Clariant Partners to Bring New Biotransformation Technology to India


The team at the signing ceremony with Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals.

Mumbai, India: Clariant, a focused and innovative specialty chemical company and Polymateria, has been developing a new standard in biodegradation of plastics, signed a partnership agreement with the Central Institute of Plastic Engineering & Technology (CIPET), Department of Chemical and Petrochemical, Ministry of Chemicals & Fertilizers, Government of India. This partnership entails bringing Polymateria's Biotransformation technology to market in India through Clariant's Masterbatches.

Clariant's Masterbatches and Polymateria will work with CIPET's world class testing facilities to apply the biotransformation technology to the local brands and packaging companies, who want to validate solutions for the most highly littered forms of plastic.

At the signing ceremony, Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals, said, "India has world leading ambitions to tackle plastic waste. With new innovations such as Biotransformation emerging, we can work with the industry to address these issues."

Niall Dunne, CEO of Polymateria, said, "This partnership agreement reflects that the only way to solve global problems is to accelerate the impact of disruptive technology through meaningful collaboration."

Sambit Roy, Head of LBL India, BU MB, Clariant, said, "We are happy with this agreement and keen to support our clear strategy towards Sustainability. Clariant has an important role to play in creating solutions for recycling and now with this new technology we will also be able to offer biodegradation solutions for fugitive plastics which are left over in recycling stream. This agreement gives us access to the global technology from Polymateria to bring the biodegradation capabilities to the Indian market; while working with CIPET's testing facilities."
Indian Society for Clinical Research (ISCR) to Host 13th Annual Conference in Mumbai

Mumbai, India: Beyond new regulations, increasing participation and enhancing patient safety is the theme of the 13th Annual Conference of Indian Society for Clinical Research (ISCR) to be held in Mumbai from January 24-25. Held against the backdrop of the New Drugs and Clinical Trials Rules, 2019 launched around a year ago, the event will bring clinical research professionals from academia, healthcare institutions, not for profit organisations and the industry together to deliberate on the road ahead for clinical research in India, as well as new and emerging areas in clinical research. Dr. V G Somani, Drug Controller General India, CDSCO, will deliver the Chief Guest address. Dr. Gagandeep Kang, Executive Director, Translational Health Science Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Ministry of Science & Technology, Govt. of India, will deliver the late Prof Ranjit Roy Chaudhury Oration.

"This year's Conference provides the right opportunity for clinical research professionals to reflect on the year that has gone by and look forward at what more we need to be doing to move the clinical research agenda in the country forward so that our patients have access to treatment for the many unmet medical needs in our country," said Dr Chirag Trivedi, President, ISCR. "India has 16% of the world’s population and 20% of the world's disease burden and yet less than 1.2% of global clinical trials are done in India (source: www.clinicaltrials.gov)." The Conference has four tracks covering Clinical Operations, Medical Writing, Biostatistics and Data Management.

Leading up to the annual conference, six pre-conference workshops have been scheduled for clinical researcher professionals, investigators and students on January 23rd. The workshops will cover Real World Evidence, Risk-based Implementation Strategy, PV Audits and Inspections and Enhancing Site and Investigator Capability among other topics.
Wockhardt: 1st Indian Company to Achieve Approval for Newly Discovered Antibiotics

Mumbai, India: Indian drug regulator, DCGI has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).

The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7 percent and is one of the largest therapeutic segment, with a 12 percent market share of the Indian Pharmaceutical Market1.

"By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality"- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group.

Antimicrobial Resistance is a medical challenge with 38 percent resistance in India. AMR is a major public health problem globally. India carries one of the largest burdens of drug resistant pathogens worldwide. Infections caused by drug -resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health -care systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India due to AMR by the year 20502.

World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a 'high' priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings3. In 2018, a national study conducted by the Indian council of Medical research (ICMR ) and Anti-microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India4. A recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die in intensive care units5.

Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, to name a few6; which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance to these agents and drying antimicrobial pipeline.

EMROK / EMROK O are the modern gram positive antibiotic against methicillin resistant Staphylococcus Aureus infections. EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India. More than 50 international publications/posters in top-notch journals/scientific conferences and studies by leading international experts have established that EMROK/EMROK-O represents a truly multi-spectrum MRSA drug with potent bactericidal action against Gram positive, quinolone susceptible Gram negative, anaerobic and atypical bacteria.

Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone-marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver function and seriously ill patients requiring for longer duration therapy.

After a significant gap of 14 years, a new anti-MRSA agent will be made available by Wockhardt as 'EMROK' for the management of resistant superbug.

Due to the combination of complexity of resistance mechanisms expressed by bacteria as well as lack of financial resources to fund antibiotic research, many major pharmaceutical firms have steered away from the antibiotic research in the last 30 years. In such challenging scenarios, Wockhardt Ltd. has invested for more than two decades in developing a strong antibiotic pipeline catering both multi drug resistant Gram positive and Gram negative pathogens and is the only company in the world having five antibiotics against superbugs in the late phase of clinical development. All these antibiotics, because of their promising activity against MDR pathogens, have received US FDA-QIDP status for expediting the drug development cycle. Out of the five, the first two antibiotics -EMROK and EMROK-O have been approved by DCGI recently and will be launched soon.
Glenmark Pharmaceuticals Receives ANDA Approval for Deferasirox Tablets

Mumbai, India: Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration(USFDA) for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade®1 Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.

According to IQVIATM sales data for the 12- month period ending November 2019, the Exjade® Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg market2 achieved annual sales of approximately $106.4 million*.

Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 43 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Bosch Packaging Technology is Now Syntegon

Waiblingen, Germany: Syntegon Technology is the new name amongst the market leaders in the processing and packaging industry. Known as Bosch Packaging Technology until late 2019, the former Bosch division has recently presented itself as an independent enterprise at the company headquarters in Waiblingen (Germany). Syntegon Technology's business focus is on intelligent and sustainable technologies for the pharmaceutical and food industries. Extending the service range is a priority for the company. Syntegon Technology employs 6,100 people at more than 30 locations worldwide. It posted 1.3 billion euros in sales in 2019. Bosch disclosed its plans to sell the packaging machinery division to a newly incorporated entity managed by CVC Capital Partners, a leading private equity and investment advisory firm, in July 2019. The transaction was completed according to plan, with the company gaining full independence at the turn of the year.

Transaction wrapped up on schedule as business development remains stable. The sale of Bosch Packaging Technology was completed on January 2, 2020, as envisioned. Bosch had announced in June 2018 that it intended to sell its packaging division, finding a buyer a year later in CVC Capital Partners (CVC). Bosch Packaging Technology then expanded its headquarters in Waiblingen, Germany, augmenting it with new departments required for the switch. Business developments remained stable in the interim, bucking the trend in the sluggish machine engineering sector. Sales in 2019 came to 1.3 billion euros, matching the previous year's figure.

The new owner, CVC, aims to vigorously develop the company as a whole and expand intra-group synergies. Commenting on the closing of the sale, Marc Strobel, a partner at CVC Capital Partners said, "CVC is delighted to see the transaction completed on schedule. Syntegon Technology has a strong presence in many market segments, great technological know-how, and innovative power. We want to build on these strengths jointly with management and the entire workforce."

Into the future with a new brand : "Processing and packaging technology for a better life!" This is Syntegon's mission statement. The company is determined to improve the lives of consumers and patients with intelligent and sustainable processing and packaging solutions. A new corporate brand was developed over the past few months. The name Syntegon stands for synergy, technology, and focus on the future. The new corporate color green underscores the importance of sustainability and health. The square in the newly designed logo symbolizes a package as well as packaging technology's ability to protect products.

The entire workforce will celebrate the independent company's launch with management on January 16, 2020. The ceremony at the Waiblingen headquarters, broadcasted live around the world, will be followed by events held at the individual locations. Syntegon Technology will share the news with its business partners today. Chairman of the Executive Board Dr. Stefan König takes this opportunity to send an emphatic message: "We are building on 150 years of experience and the 64,000 machines deployed by our customers, and pursuing new avenues of business. Now, more than ever before, we are working on intelligent and sustainable technologies and embracing the collaboration with our business partners in the true spirit of partnership."

Greater flexibility and focus on caring partnerships: This newly gained independence enables Syntegon Technology to be even more flexible. And newly added departments at the headquarters such as Purchasing and IT shorten the distances between in-house units and facilitating interaction with customers and suppliers. Whereas the company had been part of a large corporation with diverse divisions, it can now create a business framework that is an even better fit for the industry. This new setup will enable the company to enhance its profile as a leading processing and packaging company.

Syntegon Technology aims to set new priorities for services. Impelled by the spirit of partnership with its customers, the company is striving to improve its processes. One goal is to reduce response times to customer enquiries; another is to further increase the availability of service technicians. Syntegon Technology is also investing in a customer and technology center at its Waiblingen headquarters. The processing and packaging technology company collaborates with global corporations and regional market leaders, and is determined to offer even more attractive services for mediumsized enterprises and startups.

Intelligent and sustainable technologies: Syntegon Technology has intensified its efforts to develop intelligent and sustainable technologies. Drawing on a deep well of experience in developing and integrating software solutions, the company uses connected components as well as components enhanced with artificial intelligence to this end. It puts a premium on ensuring sophisticated technologies are simple to use. The greater goal is to collect and evaluate data to avoid machine downtime, maximize product quality, and optimize overall plant efficiency.

The enterprise is pursuing two approaches to produce sustainable packaging - one is to use mono materials rather than conventional multilayer films, and the other is to use paper packaging as an alternative to plastic. Syntegon Technology supports its customers on the path to a sustainable future with material testing, machine applications, and innovative packaging designed to meet the requirements of products, transport modes, and regional circumstances. The company has also significantly reduced its machines' energy consumption.

The numbers speak for themselves : A campaign to train the spotlight on Syntegon Technology's new brand is underway. The company is letting the numbers tell the story. Featuring prominently on the website at www.syntegon.com/numbers, these persuasive figures show what Syntegon is all about. The next highlight on the agenda is the Düsseldorf interpack trade fair, where the company will present its fresh, new brand identity to customers in May 2020.
Transgene and NEC Start Two Clinical Trials with TG4050, an AI-Powered Cancer Vaccine for Ovarian and Head & Neck Cancers

Tokyo, Japan: Transgene is a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation is a leader in IT and network technologies. They both has recently announced that the first patients have been enrolled in the first-in-human trials evaluating TG4050, a therapeutic vaccine based on the myvac technology and powered by NEC's cutting-edge AI capabilities. In these Phase 1 trials, TG4050 is being administered to patients with head and neck cancer who have a high risk of relapse after surgery and patients with ovarian cancer after surgery and adjuvant therapy.

Transgene's highly innovative myvac technology allows the generation of virus-based immunotherapy within a very short time frame while encoding patient-specific mutations identified and selected by NEC's Neoantigen Prediction System. TG4050 has been designed to target up to 30 patientspecific neoantigens (cancer cell mutations). They are selected using NEC's Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary immune data, allowing it to accurately prioritize and select the most immunogenic sequences.

Transgene uses its expertise in viral vectorization via myvac to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Company has also set up a unique in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the clinical development of this novel therapeutic vaccine.

"As each patient's cancer is unique, we have developed a therapy that turns their solid tumor's genetic signature into a powerful highly specific anticancer weapon. TG4050 is based on an MVA viral vector that has proven biological activity and has the ability to elicit an immune response against tumor antigens. Our partnership with NEC ensures that TG4050 is benefitting from its world-leading expertise in artificial intelligence and its unique algorithm that is used to select up to 30 patient-specific antigens that allow this novel vaccine to induce a strong immune response. We are convinced that TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer," explained Philippe Archinard, Chairman and Chief Executive Officer of Transgene.

"We are excited to enroll our first patients in these trials and see TG4050 advance to the clinic. This is another step closer towards the realization of an AI-driven individualized immunotherapy for each patient. Our unique partnership with Transgene enables us to leverage its significant clinical development know-how and proven viral vector delivery platform. We are hopeful that TG4050 will make a significant difference for patients throughout the world," commented Osamu Fujikawa, Senior Vice President, NEC Corporation. A Phase 1 clinical trial of TG4050 is enrolling patients with ovarian cancer after surgery and first-line chemotherapy. This multi-center, one-arm trial will recruit patients in the USA and in France. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. Dr. Matthew Block, MD, PhD, immunologist and medical oncologist at the Mayo Clinic, is conducting the trial in the USA; in France, the trial will be conducted by Dr. Martinez at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie.

Another Phase 1 clinical trial of TG4050 is enrolling patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) that have received an adjuvant (first-line) therapy after surgery. This multi-center, open-label, randomized two arms trial will include patients in the UK and in France. Patients will receive either TG4050 monotherapy after completion of the adjuvant therapy or in combination with the standard of care at the time of recurrence. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. In France, the trial is being conducted by Pr. Delord at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie; in the UK, the trial is coordinated by Pr. Ottensmeier from Southampton University. Both studies are sponsored by Transgene and are co-financed by Transgene and NEC.
Change in Management in Sanner Group: Ralf Tiemann is the New CEO and Dr Johannis Willem van Vliet is the New CTO

Bensheim/Germany: Sanner – the international supplier of high -quality plastic packaging and components for pharmaceutical, medical and healthcare products - renewed its organizational structure. Ralf Tiemann was appointed as the CEO of the entire Sanner Group. He is supported by a three-member team consisting of the new CTO and Managing Director of Sanner GmbH, Dr. Johannis Willem van Vliet, the vacant position of CSO and the long-standing CFO Claudia Tonhäuser.

Sanner is set for further growth. Accordingly, the Bensheim-based company has decided to reallocate responsibilities within the organization. Ralf Tiemann, who has headed the subsidiary Sanner Pharmaceutical & Medical Packaging Materials Co. Ltd. based in Kunshan, China since 2008, took over the newly created position of CEO of the entire Sanner Group on January 1, 2020. "Sanner is in an excellent international position to continue on its growth path," says Tiemann. "In addition to investments in the different locations, we will also successively expand our portfolio in the coming years. This includes intelligent solutions for greater therapeutic adherence as well as sustainable, biobased plastic packaging".

Dirk Mähr, member of the management board of Sanner GmbH since August 2015, left the company at the end of 2019. Therefore Sanner GmbH appointed Dr. Johannis Willem van Vliet to the management board last summer. As CTO, he is responsible for production, development and quality. Until the position of CSO is filled, van Vliet will also temporarily assume responsibility for sales, marketing, product management and personnel. As Vice President of Ottobock healthcare products GmbH, van Vliet most recently headed the development department for 2 medical products in Vienna. He holds a PhD in mechanical engineering and has many years of experience in research and development as well as production and automation. "This is ideally in line with Sanner's strategic orientation: we want to further strengthen the company in international competition with higher investments in development activities, Industry 4.0 and the expansion of the medtech portfolio," says van Vliet.

Claudia Tonhäuser will continue to be responsible for finance, controlling, purchasing and IT. The business informatics graduate has been with Sanner GmbH for many years and has held the position of CFO since 2010.
Clarivate Analytics Highlighted India as an Emerging Hub for Biologics and Biosimilars

New Delhi, India: Clarivate Analytics plc, a global leader in providing trusted insights and analytics to accelerate the pace of innovation, has released a new report together with the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and ABLE (Association of Biotechnology Led Enterprises). Entitled 'India: The emerging hub for biologics and biosimilars', the report features analysis based on insights from Cortellis Deals Intelligence™ and Cortellis Competitive Intelligence™, and it can be downloaded.

The report examines the transformation of the pharmaceutical/ biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars), driven by unmet clinical needs, the inherent advantages of biotherapeutics, and commercial potential. Of the top 10 blockbuster molecules in 2018, only two were small molecule therapeutics and eight were biological therapeutics.

The report was released at the Global Bio-India 2019 in New Delhi by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Shri. Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr. Renu Swarup, Secretary, DBT and other luminaries including Prof. Vinod K. Paul, Member NITI Aayog and Dr. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Limited.

Dr. Renu Swarup, Secretary, Department of Biotechnology said, "India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle class patients."

The Indian pharmaceutical/biotech industry is well placed to capitalize on the substantial opportunity offered by biotherapeutics and includes companies with an extensive pipeline of biosimilars under active development.

Kiran Mazumdar, Chairperson and Managing Director, Biocon Limited, said, "Technological innovation, coupled with economies of scale, are driving India's emergence as a global hub for biologics and biosimilars. In enabling affordable access to high quality biosimilars worldwide, India's biopharma sector can emulate the global leadership achieved in generic drugs and vaccines." Dr. Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, "India's contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science."

So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.

"Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization," concluded Arvind Pachhapur, Vice President, Clarivate Analytics.
Cadila Pharma Showcased Its Might at CPhI Frankfurt



Ahmedabad, India: Cadila Pharmaceuticals, one of the biggest pharma companies in India and known for innovation and quality, participated in the recently concluded CPhI Worldwide event held in Frankfurt, Germany.

CPhI is one of the biggest pharmaceutical industry buyer-seller meet where pharma stakeholders can come and interact to grow their business. Cadila's International Formulations team and the Active Pharmaceutical Ingredient (API) team participated in the event where they talked about their products and expertise. Their products which are heavily based on research and development, got a great response from the buyers. The event was held from 5 to 7 November, 2019 in Messi, Frankfurt.

Leading Cadila's International formulations team at the event, Mr Mahidhwaj Sisodia, Executive Vice President, International Business, said "We are excited to be at CPhI Frankfurt. We are very well poised to serve the growing finished formulations market across the globe. We met delegates from multiple countries and the feedback throughout has been very encouraging."

The next CPhI event will be hosted in Delhi, India from 26 to 28 November, 2019 expecting to see multiple stakeholders attend the event.
Biocon Biologics & Just-Evotec Biologics Signed Licensing Deal for a Biosimilar Asset

Bengaluru, India; Hamburg, Germany; and Seattle, USA: Biocon Limited and Evotec SE have recently announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just-Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset.

Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, and manufacturing & commercialization postregulatory approval under its own label in global markets. Biocon Biologics aims to address the needs of a large patient pool through this differentiated therapy. Through this in -licensing deal, Biocon Biologics has expanded its current therapeutic basket of biosimilars going beyond diabetes, oncology, and immunology.

Just-Evotec Biologics has a unique platform with deep experience in the fields of protein, and process & manufacturing sciences, which it has leveraged to develop this complex molecule. Just-Evotec Biologics has received an undisclosed license fee from Biocon Biologics and will be eligible to receive development, regulatory, and commercial milestone payments.

Dr Christiane Hamacher, CEO, Biocon Biologics, said: "We are extremely confident of the quality of the biosimilar asset developed by Just-Evotec Biologics and this collaboration will provide a head start for Biocon Biologics to commercialize a biosimilar under its own brand. Leveraging our R & D skills and manufacturing expertise, we aim to take this differentiated therapy from ‘bench to bedside'. This product expands our therapeutic basket and will enable us to address unmet patient needs for a high quality affordable therapy".

Dr James N Thomas, EVP, Global Head Biotherapeutics & President US Operations at Just-Evotec Biologics, said: "We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars. Just-Evotec Biologics' optimised product and process platform has generated an excellent early-stage product candidate which we have licensed to Biocon Biologics for further development using their late-stage development, manufacturing and commercial capabilities to bring a compelling treatment to patients. We look forward to providing support to the Biocon Biologics team as their program advances towards the clinic”. Dr Thomas added, "This is the beginning of a great relationship between Just-Evotec Biologics and Biocon Biologics".

Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just-Evotec Biologics' vast experience in the process development domain, particularly with respect to optimised manufacturability.

R & D is at the core of Biocon Biologics' journey towards meeting its strategic long-term goal to address the needs of millions of patients worldwide. Biocon Biologics' scientific expertise and world class R & D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe.

Biocon Biologics has a product pipeline of 28 molecules including 11 with Mylan, several with Sandoz, and is developing many independently. The Company's therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology, and inflammatory diseases.
Firms Collaborate on Next Generation Pick and Place Delta Robotics

Ecublens, Switzerland: Pioneering Swiss robotics company Demaurex has signed a joint development agreement with Genesis Robotics and Motion Technologies to produce advanced components to boost packaging line robotics.

Demaurex has been an industry leader for high speed pick and place robotics; and will integrate with Genesis Robotics’ LiveDrive Direct-Drive Moto into its latest generation Delta Robot Systems.

Demaurex engineered and industrialised the original Delta robot in 1988, based on a patent of Reymond Clavel of the Ecole Polytechnique Federale de Lausanne (EPFL), introducing high speed, vision guided product pick and place systems to the robotics market for the first time.

Demaurex has been operating in the food pharma packaging market for decades; its robots are moving items, less than 3kg in weight, quickly form one position to another.

It also works in the consumer goods market - personal care, as well as bakery, produce, fresh meat, vegetables etc.

The key area the company started in was confectionery, when one of its chief technology officers saw a 20kg robot picking and placing 20g chocolate packs.

Genesis Robotics' LiveDrive Direct Drive Motor is designed to improve performance, reduces maintenance, and increases up-time.

The key feature of the technology is its reduced components size which improves the level of speed, torque, and precision on packing and packaging lines in various industries.

Frank Souyris, General Manager at Demaurex, said: "The LiveDrive technology offers new levels of simplicity and ease of use, eliminating the need for costly, bulky and unhygienic gearboxes all in a much smaller envelope. This will result in reducing the total cost of ownership and promoting ease of use for our customers."

Most robots feature components, motors and gears adding up to around 500mm. The length of the live drive is less than 60mm.

Roy Fraser, Vice President of Product at Genesis Robotics, told Packaging News: "This is one of the core unique selling points; it gets the robots much close which improves the robot density and subsequently the pick density. The LiveDrive produces lower inertia and lower mass and up to three times as much torque ratio. It means the motor can start and stop very fast - making it much more productive, efficient, and reliable."

Fraser explained that not only was the motor made smaller, the technology removed the gearbox too. He mentioned, "removing the gearbox means removing the risk of contamination, breakdown, and maintenance. Additionally, power consumption is lower."

James Klassen, inventor of LiveDrive, added that the collaboration between Demaurex is significant for Genesis because it demonstrates that the power density of the LiveDrive motor can help redefine the Delta Robot.

"The platform itself is what the industry has been waiting for: a high torque actuator that delivers three times higher torque density, high peak torque capacity, and the highest levels of precision. Taking advantage of three foundational discoveries - Magnetic Amplification, Advanced Structural Magnetic Architecture, and unparalleled Heat Dissipation - the LiveDrive Direct-Drive motor provides manufacturers with the ability to design simpler, faster, and more precise robots and machines."

Chris Di Lello, Chief Executive of Genesis Robotics and Motion Technologies, added: "We are honoured to work with Demaurex SA as we believe that this collaboration demonstrates the powerful outcome that can be achieved when two companies with shared values, an intense desire to improve on the status-quo, and a deep respect for each other work together in true partnership."
Roche and Spark Therapeutics, Inc. Announced Extension of Tender Offer

Basel, Switzerland; and Pennsylvania, United States: Roche and Spark Therapeutics, Inc. announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the "Shares") of Spark for USD 114.50 per share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the offer to purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the "Offer").

Pursuant to the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings Inc., 022019 Merger Subsidiary, Inc., and Spark (as amended, the "Merger Agreement"), the Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on Wednesday, July 31, 2019, has been extended until 5:00 p.m., New York City time, on Tuesday, September 3, 2019, unless it is extended further under the circumstances set forth in the Merger Agreement. All terms and conditions of the Offer shall remain unchanged during the extended period.

The Offer was extended to provide additional time for the US Federal Trade Commission (the "FTC") and the UK Competition and Market Authority (the "CMA") to complete their previously disclosed reviews of Roche's pending acquisition of Spark. The parties remain committed to the transaction and are working cooperatively and expeditiously with the FTC and the CMA.

Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 pm, New York City time, on July 30 2019, approximately 9,715,086 Shares of Spark (none of which were tendered by notice of guaranteed delivery) had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 25.2 percent of Spark's outstanding Shares. Stockholders who have already tendered their Shares of Spark do not have to re-tender their Shares or take any other action as a result of the extension of the expiration date of the Offer.

Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, a majority of the outstanding Spark Shares. McKenzie Partners Inc. is acting as information agent for the Offer.
Facing Headwinds in the US, Natco Pharma Looks to Scale Up its Business in China

Hyderabad, India: Natco Pharma is focusing on filing of cancer treatment drugs in China, the world's second largest pharmaceutical market, as part of its strategy to diversify its business in various emerging markets amid headwinds in the US. Addressing to the shareholders in the company's Annual Report for 2018-19, Natco Pharma Chairman and Managing Director V C Nannapaneni said the company had foreseen imminent headwinds in the US market and had begun diversifying its resources towards building businesses in new markets. Those investments are now reaping rewards, he added.

"We are currently investing to further establish our presence in Australia, Singapore, China, and South East Asian countries; and are confident that our businesses in these markets will propel growth in the future", Nannapaneni said. In the near term, growth for the company would continue to be driven by markets viz India, Brazil, and Canada, he added.

"As we continually balance our portfolio of products and growth in the US, we expect majority of revenue to be coming from non-US markets," Nannapaneni said. Commenting on the company's plans in the China market, he added that it is focusing on oncology product filing in the country.

China is the second largest pharmaceutical market globally with total spending of USD 137 billion in 2018. Government reforms to improve insurance access and recent upgrades in the hospital and primary care infrastructure have led to increase in spending on healthcare initiatives.

China's pharma market is likely to grow at 3-6 per cent to USD 140-170 billion by 2023 as against Brazil which is likely to grow at 5-8 per cent to USD 30-43 billion.

Nannapaneni also said the drug firm has also begun exploratory work for expansion into Africa. "We believe that this will help us to diversify further into new geographies for growth", he said.
Maharashtra to Set Up Single Window Clearance System for Pharma Companies

Maharashtra, India: The Maharashtra Government is planning to attract pharmaceutical companies to set up base in the state and has decided to set up a single-window system to grant them clearances and address their grievances.

Food and Drug Administration (FDA) Minister Jaykumar Rawal recently held meetings with representatives of the Indian Drug Manufacturing Association to understand why the pharma companies, for whom Maharashtra was earlier a preferred destination, shifted to Himachal Pradesh in recent years.

Earlier, around 3,000 pharma companies had their manufacturing units in Maharashtra. But gradually, majority of them shifted to Himachal Pradesh due to various sops offered there, Rawal told reporters here during the weekend.

"I found out during my meetings with the stakeholders that these companies face a big hurdle in getting environmental clearances.

The FDA will set up a single-window clearance system to help in this matter", he said.

Rawal said there were plans to make Nagpur and Aurangabad as the Pharma Hubs in the state. In Nagpur, work is already in progress at MIHAN(Multi-modal International Cargo Hub and Airport at Nagpur), he noted. "The focus will be on production of Ayurvedic medicines. There are plans to make a pharma hub between Aurangabad and Nashik along the Mumbai-Nagpur Samruddhi Corridor. Plans are also afoot to set up a world class lab at the pharma hubs", the minister said. "We want to compete with China in the production of generic medicines", he further said.

The Indian pharma products have a good response in Europe, he commented, adding that Bosnia is keen on a joint co-operation with Maharashtra in the pharma sector.
Herma to Present New Colour Print and Apply System for Personalised Packaging at FachPack 2019

Nuremberg, Germany: At FachPack 2019 from 24-26 September 2019 in Nuremberg, Germany, HERMA (hall 3A, booth 236) will present the new PA8 4C Print & Apply System, a solution break through that meets the demands of personalization, efficiency, and market demands while providing optimal color quality. The system, one of the first of its kind, allows for full-color, edgeto-edge print on white labels and the exact assignment of each completely individualized label to the respective packaging unit. Possible labeling types are top labeling as well as L- and C-shape labeling. The label applicator, which was especially developed for this system, ensures that only the last label printed is applied. Memjet VersaPass technology is used to manage the printing of the labels. "We choose Memjet for this solution because of its outstanding print quality", says Ulrich Fischer, Head of Product Management at HERMA's Labeling Machines Division. "In addition to image quality, the safety of the water-based ink is ideally suited for applications in the pharmaceutical or food industries."

Suitable labels for Memjet technology are available as paper or PP film versions with glossy or matt surfaces. Memjet's integrated four color management system (CMYK) ensures that preset color accuracy for logos, and defined spot colors of a brand owner design, are achieved with precision regardless of the label material. "Packaging that has been individualized in that manner meets brand owner requirements and increase marketing effectiveness", says Fischer.

Just-in-time design: Ulrich Fischer pointed out, "As we are frequently talking about very small batch sizes in late stage customization, one will always have to consider for each case whether automated systems make economic sense." Regarding packaging dimensions, the system is currently designed for sizes between 90 x 50 x 15 mm to 150 x 150 x 30 mm (L x W x H). Format sets are used to adapt the system to different packaging sizes. Label sizes can vary between 45 x 85 mm to 175 x 150 mm (W x L). "Combined with the possible labeling types, this gives users maximum design freedom", added Martin Kühl, Head, Labeling Machines Division, HERMA. "The system allows them to design only the actually required packaging unit just in time, with no need to store many pre-printed folding cartons".
Eris Lifesciences and PlexusMD Joined Hands to Offer Saarthi

Ahmedabad, Gujarat: Eris Lifesciences – a leading pharmaceutical company, and PlexusMD - India's largest professional networking platform for doctors, have recently announced their partnership for a unique AIempowered learning platform named "Saarthi". Through this endeavour, the companies aim to enable Indian physicians to stay connected with global developments and practise evidence-based medicine to improve patient health outcomes. Artificial intelligence (AI) empowered technology and machine learning can help tailor the content and adapt the pace of delivery to each practising physician’s unique learning needs for them to apply the insights more effectively in their practice.

This app-based platform will be a one-stop destination to provide Continuing Medical Education (CME), medical content, medico-legal precedents, medical conference feeds, case discussions, etc. for physicians. "Saarthi" is an interactive, innovative, and relevant platform to simplify learning for doctors, who continuously face time-constraints in their attempt to keep abreast with latest developments in the medical field.

With an artificial intelligence empowered technology, Saarthi will help doctors in their evidence-based practice as each patient case can be unique. A distinctive feature of the app is a calculator that will help doctors quickly arrive at the right dosages, drug combinations, and diagnostic criteria for commonly encountered situations.

Highlighting the need for such an offering, Dr. Viraj Suvarna, President Medical, Eris Lifesciences Ltd. said: "This is a collaboration between two very exciting pioneers, one from the pharmaceutical space and the other from technology. This partnership is a step forward in a domain that requires deep learning but where time constraints become a major deterrent for doctors".

Elaborating on the partnership, Dr. Rohan Desai, Founder, PlexusMD, said: “E-learning is the reality in every domain, including medicine. Saarthi is a unique platform where an AI-empowered engine will deliver precise and customized content to the enrolled doctors depending on their interests and learning requirements. The app will address two critical issues in today's time -information overload and fake news - to ensure doctors are provided with information relevant to them."

"Technology has made learning an enjoyable experience. The traditional learning that doctors were exposed to during their graduation and postgraduation days can now be made exciting with the use of technology. Doctors can learn from case studies using virtual and augmented reality".

Eris Lifesciences is focused on filling up the gaps in patient care: diagnostics , therapeutics and patient compliance. PlexusMD, an online professional network for medical professionals and healthcare organisations, is centered on professional growth of doctors.
LIVI Announced New NHS Partnership

United Kingdom: LIVI, the UK division of European digital healthcare provider KRY, has announced a collaboration with Northampton General Practice Alliance, Alliance for Better Care, as well as other partners across the South East for health partnership.

The partnership aims to bring access to app-based video GP consultations for over 1.85 million NHS patients, enabling local GPs to also work on the platform helping to treat patients in their area digitally.

The company is already operating in North-West Surrey, with the service available to over 360,000 patients. The service will now be extended to Birmingham, Shropshire, Northamptonshire, and parts of the South-East, as well as extending services to more practices in Surrey, meaning that LIVI will now offer services to 1.85 million patients.

The partnerships come at a time of significant pressure for the UK’s Primary Care Networks, with the NHS struggling to recruit and retain doctors, particularly in crucial areas such as paediatrics.

Video consultations have been cited as a way to take the strain off GPs, as well as offering them greater flexibility, support, and more meaningful work, since they can focus their time in the surgery on the patients who need it most.

Luke Buhl-Nielsen, UK Country Manager of LIVI, said that the company's mission is to improve access to primary care for every patient and it does so in a way that significantly relieves pressure on GP surgeries. He continued, "Our first partnership in North-West Surrey highlighted within the first six months of the positive impact that LIVI can have - offering GPs greater workplace flexibility, decreasing attendance at A+E or Urgent Care Centres, while delivering excellent care for every patient. We're excited to see the future impact of our new partnerships for both patients and care providers.

NHS England's recently published GP Patient Survey showed a sharp decline in the number of patients in North-West Surrey. It has been revealed that they would have attended A & E as an alternative to seeing a GP, revealing a 28 percent drop in the number of patients reporting that they went directly to A & E after being unable to get a suitable GP appointment in the year since August 2018.
Glenmark Pharma Received USFDA Nod for Cholesterol Lowering Drug

Mumbai, India: Glenmark Pharmaceuticals has announced that it has received final approval from the US health regulator for Ezetimibe and Simvastatin tablets, used for treating high levels of cholesterol in the blood.

The approved product is a generic version of MSD International's Vytorin tablets. The approval has been granted by the United States Food and Drug Administration (USFDA) for Ezetimibe and Simvastatin tablets in the strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement.

Citing IQVIA sales data, Glenmark said Vytorin tablets' market achieved annual sales of approximately USD 92.4 million for the 12-month period ended April 2019.

The company said its current portfolio consists of 157 products authorised for distribution in the US and 58 ANDAs pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.55 per cent higher at 450.80 apiece on BSE.
Bayer Acquired BlueRock in Cell Therapy Move

Leverkusen, Germany: Bayer AG has announced that it is to fully acquire BlueRock Therapeutics, a privately held US-headquartered biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology by using a proprietary induced pluripotent stem cell (iPSC) platform.

The news comes following a 2016 joint venture with Versant Ventures to establish BlueRock Therapeutics, and Bayer will now acquire the remaining stake for approximately USD 240 million in cash to be paid upfront at closing, and an additional USD 360 million payable upon achievement of pre-defined development milestones.

BlueRock Therapeutics' portfolio of cell therapies is currently focused on neurology, cardiology, and immunology with a lead program in Parkinson's disease expected to enter the clinic by the end of 2019.

“The acquisition marks a major milestone on our path towards a leading position in cell therapy", said Stefan Oelrich, member of the Board of Management, Bayer AG and President of Pharmaceuticals Division. "In line with our strategy to ramp up our investments in technologies with breakthrough innovation potential, we have decided to build our cell therapy pipeline based on BlueRock Therapeutics' industry-leading iPSC platform. Ultimately, we are joining forces to deliver new treatment options for medical needs that are still unmet today."

After the acquisition, Bayer will own full rights to BlueRock Therapeutics’ CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities.
Kite Introduced New Indicators to its Temperature Sensitive Packaging Range

Coventry, England: Employee-owned business, Kite Packaging, has released its new temperature indicators to help businesses accommodate a maintained temperature in transit.

These new temperature indicators are small self-adhesive labels that go inside chilled packaging to facilitate contents that need to be kept at a certain temperature.

They monitor the temperature throughout a specified time period and indicate when their maximum threshold has been breached. Each indicator also informs users about how long the contents have been above the specified threshold temperature. Temperature indicators are commonly used with many food, pharmaceuticals, and medical products to show the accumulated time-temperature history of a product.

There are two specifications available: food temperature indicators and pharmaceutical temperature indicators, ranging from temperatures 5-8°C and have varied time frames.

Each of Kite Packaging's indicators are self-activated and will ensure chilled goods get to their destination at the desired temperature that businesses require.

The temperature indicators are another addition for the business's new chilled packaging range, which features enviro-friendly insulated boxes, insulated box liners, ice packs, thermal pallet overs, and temperature controlled pouches.
Stempeutics, Kemwell in Joint Development and Marketing Pact for Stem-cell Products

Bengaluru, India: Bengaluru-based firms Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG) and Kemwell Biopharma have joined hands for global commercialisation of Stempeutics' stem cell product Stempeucel.

Under the agreement announced on July 22, Kemwell will take a minority stake in Stempeutics and invest up to 95 crores based on certain milestones as well as establish a world class cGMP cell therapy manufacturing facility at Kemwell's facility in Bengaluru for contract manufacturing of cell therapy products.

Currently Stempeutics is working on three key indications i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA), and Diabetic Foot Ulcer (DFU). For marketing the products in India, it has partnered with Cipla for the CLI indication and with Alkem Labs for OA indication. Stempeutics is now exploring registration and commercialisation of Stempeucel in developed markets. Funds received from Kemwell will be utilised for achieving key regulatory milestones in the US, Europe and Japan, as stated by the Company spokesperson. Commenting on the Kemwell collaboration, Ranjan Pai, Chairman, Manipal Education and Medical Group said, "We are progressing well towards our goal of bringing stem cell-based products for unmet medical needs in the Indian market by Yr 2020. Stempeutics has done pioneering work in stem cells R & D and by far, it is the first stem cell company in Asia to demonstrate significant clinical outcomes in CLI. The synergistic combinations of Kemwell and Stempeutics will accelerate the development of novel stem cell-based products for patients and will transform India into a global player in stem cell therapeutics."

Anurag Bagaria, Chairman and CEO, Kemwell added, "We believe that Stem Cells will become a major branch of medical treatment and a standard of care for challenging diseases. Kemwell is looking forward to building a world-class cGMP facility in Bangalore and make India as an emerging hub for cell therapy manufacturing. We are happy to partner with Stempeutics because of their strength in developing innovative stemcell products starting from basic research, preclinical studies, large scale manufacturing, and conducting multi-centre clinical studies meeting international standards."

Chandru Chawla, Executive Vice President - Cipla and Board Member, Stempeutics added: "Stempeutics has been at the cutting edge of stem cell research and remains among the top cell therapy companies in the world bringing therapeutic products for difficult-to-treat diseases. It has made Invent-in-India a reality".

B N Manohar, CEO of Stempeutics said, "Our Company's mission is to develop innovative stemcell products addressing major unmet medical needs with an India first, global next approach. In the past 10 years, we have developed cutting-edge technology to bring stem cell products in India to physicians who now have an off-the-shelf stem cell therapy in their hand to fight diseases like Critical Limb Ischemia. With Kemwell's investments, we plan to register for additional indications for Stempeucel, expanded into the developed markets, and further to develop our pipeline."
Cipla Re-enters Chinese Market in Joint Venture with Jiangsu Acebright

Mumbai, India: Mumbai-based global pharmaceutical major Cipla has announced that it has entered the Chinese market in a joint venture with Jiangsu Acebright. Cipla will set up a manufacturing plant for respiratory products in China under the joint venture.

A combined total investment of USD 30 million will be made for the joint venture. Cipla EU, a wholly-owned subsidiary of Cipla, will hold an 80 percent stake and Acebright will hold a 20 percent stake. Even though Cipla will start off with respiratory products in China, the pharma company aims to expand to other segments in the future, according to Umang Vohra, MD & Global CEO of Cipla.

"We are keen to take our well-established expertise in the respiratory segment to patients in China. Simultaneously, we will explore various routes to build a product portfolio in other therapeutic segments such as oncology", Vohra said. He also added that China would be an important part of their future roadmap.

"While our core home markets remain our current growth anchors, we see China as a crucial part of our future roadmap. In May, we inaugurated our office in Shanghai. We have a long-standing relationship with Acebright, and this partnership to build a manufacturing facility in China is a significant step for us", he said.

Meanwhile, Shengping Xu, Chairman of Acebright Group, said: "We have a long-standing partnership of more than 20 years with Cipla which shares our vision and approach towards patients. We are pleased to strengthen our relationship with Cipla through this joint venture and strongly believe the joint venture will bring more products to Chinese patients in the respiratory segment."

This is not the first time Cipla has entered the Chinese market. In 2012, the pharma major held stakes in three different Chinese companies: 25 percent in Biomab, 48.2 percent in Jiangsu-based Cdymax and 16.6 percent in Shanghai Desano Pharmaceuticals.

Cipla later rejigged its investments letting go of the stake in Biomab and Cdymax. It sold its stake in Jiangsu-based Cdymax in 2014 for USD 18.5 million. The share in Hong Kong-based Biomab was sold in 2015 to British Virgin Islands-based Biomab Brilliant for USD 25.8 million.
Cipla Profit Rises 6% to 478 Crore

Mumbai, India: Drug maker Cipla has reported a net profit of ` 478.19 crores for April-June period. That marked an increase of 5.97 percent compared to the corresponding period a year ago. In a regulatory filing during market hours, Cipla said its revenue from operations grew 1.27 percent to Rs. 3,989.02 crores in the quarter ended June 30. The pharmaceuticals major had posted a revenue of Rs. 3,938.99 crores in the first quarter of financial year 2018-19.

In a presentation to investors, the company said that despite significant global volatility and revenue deferrals, its profitability was maintained in the first quarter of the current financial year.

The Mumbai-based drug-maker said its international sales grew 8 percent to Rs. 2,466 crores in the quarter. Its domestic sales however declined 8 percent to Rs. 1,429 crores.

Its revenue from the pharmaceuticals business stood at Rs. 3,959.93 crore, marking a year-on-year increase of 1.22 percent. Its India operations contributed 34 percent to the total revenue while North America accounted for 28 percent, Cipla said in its presentation.

The company said that its earnings before interest, taxes, depreciation, and amortisation (EBITDA) rose 25 percent on year to Rs. 905 crores in the April-June period.

Shares in Cipla jumped as much as 4.97 percent during the session, before settling with a gain of 3.76 percent on the BSE after the earnings announcement, outperforming the benchmark Sensex index which fell 0.77 percent.
Vitafoods Asia Assists Companies to Develop their Nutraceutical Business

Singapore: At Vitafoods Asia, buyers can source products that address core and new health areas, such as combating the effects of pollution by using an oral nutraceutical.

Monteloeder is a returning exhibitor at Vitafoods Asia 2019. “Vitafoods Asia is a good platform to interact with customers from Southeast Asia,” said Ignacio Cartegna, Vice President of Sales, Monteloeder.

“Our company develops branded ingredients that we sell in more than 40 countries”, added by Cartegna. He said that the main challenge is a “lack of resources and the disparity of legislation. If you want to develop something different, supported by clinical studies, that comply with the legislation, and that is capable of competing in the market you need resources.”

In Asia, particularly in China, India, Korea, and Vietnam, pollution is a serious issue to which, Cartegna commented, Monteloeder are responding. “Exposure to air pollutants have been associated with premature skin ageing, dryness, acne, skin rashes, pigmentation problems, and wrinkles. Among all the pollutants, particle matters of more than 2.5 μm are especially dangerous as they penetrate deep the lung tissues and are linked to many diseases.”

This year, at Vitafoods Asia, he said, “We are presenting Zero Pollution, which is the first oral ingredient to prevent and repair some of the damaging effects leading to pollution exposure, especially on the skin. So, it is a skin product.”

To help companies like Monteloeder, Vitafoods Asia provides solutions for entities of any size to build a nutraceutical business in Asia. Visitors to Vitafoods Asia can leverage the exhibition and conference to source ingredients and raw materials, to meet with contract manufacturers, to source branded finished products, to discover packaging options, or to source services that help to address research, marketing, packaging, product development, or regulatory issues.
Study Shows Personal Digital Devices may Help in the Identification of Mild Cognitive Impairment, Mild Alzheimer's Disease Dementia

Indianapolis and San Mateo, United States: Initial results from a feasibility study conducted by Eli Lilly and Company, Evidation Health, and Apple Inc. showed that an iPhone, Apple Watch, iPad and the Beddit sleep monitoring device, in combination with digital apps may be able to differentiate people with mild cognitive impairment (MCI) and mild Alzheimer's disease dementia. The exploratory results were presented at the Association for Computing Machinery's KDD conference in Anchorage, and are published on the conference website as one of the top papers of the conference.

"Over the past few years, we've seen how data and insights derived from wearables and mobile consumer devices have enabled people living with health conditions, along with their clinicians, to better monitor their health," said Nikki Marinsek, PhD, a first author and data scientist at Evidation Health. "We know that insights from smart devices and digital applications can lead to improved health outcomes, but we don't yet know how those resources can be used to identify and accelerate diagnoses. The results of the trial set the groundwork for future research that may be able to help identify people with neurodegenerative conditions earlier than ever before."

"Lilly has been leading the fight against Alzheimer's disease for more than 30 years, and we're broadening the application of digital health to identify tools that may improve the lives of people with chronic conditions and diseases", said Divakar Ramakrishnan, PhD, Lilly's Chief Digital Officer. "While further research is needed, the study findings provide important insight into the potential benefits of wearable devices in identifying chronic health conditions such as MCI, Alzheimer's disease, and Dementia. These findings could inform subsequent research that may eventually lead to early screening or detection tools for neurodegenerative conditions."

In ways not previously detected through common clinical screening tools, data obtained through the use of Apple devices suggested an ability to differentiate between individuals with mild cognitive impairment and mild Alzheimer's disease dementia, and those without symptoms. The 12-week study evaluated 113 participants, ages 60-75, in real-world settings to determine whether Apple devices in combination with mobile applications, were able to help identify cognitive and behavioral differences among the study participants with and without mild cognitive impairment.

Evidation established a secure study platform to obtain study participants' consent to collect and analyze 16 terabytes of data across a number of sources, including: passively derived sensor data from the smart devices, questionnaires about mood and energy, and simple assessment activities on the Digital Assessment App.

The App included psychomotor tasks, such as dragging one shape onto another or tapping a circle as fast and as regularly as possible, reading tasks and a typing task.

"With further study, we may be able to screen people at high risk or detect dementia and Alzheimer's earlier with the devices we use in our everyday lives," said Christine Lemke, Co-founder and President of Evidation Health. "These early findings suggest the potential of novel digital measures that are based on data generated and controlled by individuals."

"We are excited to work alongside Lilly and Evidation in supporting the research community, as they seek to discover digital biomarkers of cognitive impairment," said Myoung Cha, Apple's Head of Health Strategic Partnerships.

The findings of the exploratory study provide feasibility evidence that wearable devices could enable solutions that may help identify and indicate when people are starting to experience cognitive decline. Specifically, these results show that Apple devices and digital applications may have the potential to:
  • Monitor symptoms of people diagnosed with MCI or mild Alzheimer's disease dementia
  • Detect cognitive changes that could be indicative of MCI
  • Test the efficacy of treatments and therapies
  • Accelerate the development of therapies used in conjunction with traditional diagnostic tools to improve accuracy of diagnoses
GSK Collaborated with Pfizer to Form New World-leading Consumer Healthcare Joint Venture

Brentford, United Kingdom; NewYork, United States: The Joint Venture brings together two highly complementary portfolios of trusted consumer health brands including GSK's Sensodyne, Voltaren, and Panadol and Pfizer's Advil, Centrum, and Caltrate. Underpinned by science-based innovation, it is the global leader in OTC products and has number 1 or 2 market share positions in all key geographies, including the US and China.

Following today's announcement, the Joint Venture will focus on completing the integration of two businesses, which is expected to realise annual cost savings of GBP 0.5bn by 2022 for expected total cash costs of GBP 0.9 billion and non-cash charges of GBP 0.3 billion. Up to 25 percent of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities.

Brian McNamara, Chief Executive Officer, GSK Consumer Healthcare, said: "Now the deal is closed; our focus will be on completing the integration of these two businesses and leveraging their combined strength. With our portfolio of brilliant, science-based brands and strong talent and capabilities, we are well-positioned to create a world-leading consumer healthcare business with stronger sales, cash flow, and contribution to earnings."

As previously announced, GSK intends to demerge the Joint Venture from the company within three years and to list the GSK Consumer Healthcare Business on the UK equity market.

Emma Walmsley, Chief Executive Officer, GSK and Chair of the Joint Venture, said: "The completion of the joint venture with Pfizer marks the beginning of the next phase of our transformation. This is an important moment for the Group, laying the foundation for two great companies, one in Pharmaceuticals & Vaccines and one in Consumer Health."
Siemens Healthineers to Buy Robotic-assisted Vascular Interventions Leader, Corindus Vascular Robotics for USD 1.1 billion

Erlangen, Germany: Siemens Healthineers AG, a healthcare provider, has entered into a merger agreement with US based Corindus Vascular Robotics Inc, a global technology leader for robotic-assisted vascular interventions.

Under the terms of the agreement, Siemens Healthineers will acquire all fully diluted shares of Corindus for USD 4.28 per share in cash or USD 1.1 billion in total. The transaction is expected to be closed by end of calendar year 2019, subject to Corindus shareholder approval, receipt of regulatory approvals and other customary closing conditions. The Corindus board fully supports the acquisition proposal. Corindus is headquartered in Waltham, Boston, Massachusetts, and currently has approximately 100 employees.

Corindus develops, produces and sells robotic systems for minimally invasive procedures. These systems help doctors to precisely control guide catheters, guide wires, balloon or stent implants via integrated imaging. The physician does not have to stand at the angiography table as usual but can control the procedure with a separate controlling module and is therefore less exposed to radiation. Corindus is currently one of the leading companies offering a robotic treatment platform for major vascular therapeutic markets, meaning coronary, peripheral vascular, and neurovascular interventions. For example, heart disease is the most common cause of death in the US Every year, more than four million percutaneous coronary interventions are carried out worldwide.

The acquisition of Corindus meets the objective of simplifying today's challenges in everyday hospital life. Robotic assisted minimally invasive procedures have the potential to reduce treatment times, increase precision during treatment, raise standardization levels in clinical procedures, and ultimately improve clinical outcomes, which is the strategic focus of the Advanced Therapies business segment.

“The interplay of exact imaging and robotic-assisted interventions will enhance both the eyes and hands of the physician, metaphorically speaking. With the addition of Corindus to our strong therapies portfolio we sharpen our procedural focus and will grow by expanding precision medicine and improving clinical outcomes. In the future, our digital and artificial intelligence-based tools will help to integrate the aspects of imageguidance and therapy even further”, said Michel Therin, President of Advanced Therapies at Siemens Healthineers.

The CorPath systems developed by Corindus will be used together with angiography systems that Siemens Healthineers sells as one of the leading suppliers. The Siemens Healthineers products make minimally invasive treatment possible by using high-quality imaging before and during medical interventions. The company's leading role in image-based minimally invasive procedures is now complemented by robotic-assisted precision medicine. This expansion strengthens the therapy position of Siemens Healthineers and underlines its role as one of the leading solution providers along the entire treatment path. This makes the acquisition of Corindus a strategically significant extension of Siemens Healthineers' therapy business.

The future integration of Siemens Healthineers digitization and artificial intelligence solutions with Corindus' robotic systems offers further promising possibilities. The aim is to further increase procedure optimization in order to enable the greatest possible degree of efficiency and clinical reproducibility. In addition, Corindus is driving forward the approval procedure for remote robotic treatment in vascular interventions. Due to the limited availability of specialists for minimally invasive procedures in many regions and the limited number of corresponding clinical facilities, remote treatment could significantly improve patients' access to treatment in the future.
Windgap Medical Partnered with ALKAbelló to Commercialize Epinephrine Auto-injector to Treat Anaphylactic Shock

Watertown, USA: Windgap Medical Inc, a privately-held pharmaceutical company, announced that it has entered into a strategic partnership with ALK-Abelló, A/S (ALK) to commercialize the company's epinephrine autoinjector (EAI) for the treatment of anaphylactic shock.

Under its agreement with Windgap, ALK has exclusive worldwide sales and distribution rights for the Windgap EAI in exchange for up-front, technical, and sales milestone payments along with tiered royalties on net sales in the USA, along with a split of net profit for products sold outside of the USA.

EAIs are used for the emergency treatment of acute allergic reactions – also known as anaphylaxis - which can be triggered by exposure to certain foods, or by exposure to venom from bee or wasp stings. There are more than 200,000 cases of anaphylaxis each year in the USA, and a study by the Asthma and Allergy Foundation of America estimated that up to 16 million Americans will experience it during their lifetime. Windgap estimates that the EAI market in the USA exceeds USD 1 billion annually, with a large unmet need that may enable significant market growth.

Windgap and its manufacturing collaborators are commercializing its ANDIPen wet/dry autoinjector platform. The first product using this platform will be epinephrine for the treatment of anaphylaxis. The EAI is designed to address many unmet patient needs like portability, temperature stability, ease-of-use, and a long shelf-life.

"Windgap is excited to be working with ALK, a world-leader in the treatment of allergy with a strong understanding of the world-wide EAI market, to help commercialize our product. Our teams are working well in partnership to support that effort," said Chris Stepanian, Windgap's CEO and Co-founder.

"Windgap has worked hard to assemble a world-class team to commercialize our epinephrine auto-injector. I believe the global market to be sizable and significantly under addressed. In addition to our partnership with ALK, we have strong support through a strategic investment by Molex Ventures. Molex represents one of our major manufacturing collaborators who is investing along-side our Series B lead investor Shepherd Kaplan Krochuk."

Windgap's products have not been reviewed by the FDA but the Company intends to seek approval first, for its epinephrine product for anaphylaxis.
Health Ministry asked Medical Device Manufacturers to Register at Information Sharing Portal as Part of MvPI

India: In order to effectively implement the Materiovigilance Programme of India (MvPI), the Union Health Ministry has directed medical device manufacturers to register at the recently launched Medical Devices Information Sharing Portal through hyperlink - www.mvpi.co.in.

This portal would serve the purpose as an India specific tool to help Indian Pharmacopoeia Commission (IPC) facilitate baseline study of products available with medical devices companies in India and assure patient safety.

IPC in consultation with Central Drugs Standard Control Organisation (CDSCO)has developed the portal to ensure that safe medical devices are available in the country.

IPC has been keenly working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015.

Other reporting tools and reference documents for manufacturers available on IPC website are an updated medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices and a handbook for MvPI.

Union Health Ministry is also planning to create a Registry of High Risk Medical Devices to effectively study and follow medical device associated adverse events (MDAE) and enable dangerous ones to be withdrawn from the market.

The registry would track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises at the manufacturer’s end.

MvPI which was launched in 2015 to ensure safety of medical devices is currently being coordinated by the IPC at Ghaziabad.

IPC functions as the NCC for MvPI and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as its collaborating centre. Technical support is being provided by the National Health System Resource Centre (NHSRC) in New Delhi.

Uptill now, MvPI has put 17 exclusive centres under it to collect and disseminate reporting of adverse events due to medical devices at the point of care besides the 270 adverse drug reaction monitoring centres (AMCs) across the country.

MDAER form launched by IPC will help generate independent, evidencebased recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number, etc.

As many as 4,700 patients in India had been affected by the faulty articular surface replacement (ASR) hip implants in India. The implant manufactured by J & J subsidiary DePuy Orthopaedics Inc was globally recalled over concerns that metallic implants could leak toxic cobalt and chromium into patient's body and pose risk to human health.
Cipla Q1 net profit rises 6% to Rs 478 crore

Mumbai, Maharashtra: Pharma major Cipla saw its consolidated net profit rise by almost 6 percent during the June quarter to Rs 478.19 crore. The company had posted a profit of Rs. 451.25 crore during the year-ago period.

Cipla reported net income from operations for the three-month period under review at 3,894.46 crore, as against 3,845.84 crore during the year-ago period. The total revenue for Q1FY20 was 3,989.02 crore, in comparison to 3,938.99 crore seen during Q1FY19.

The company reported EBITDA (Earnings Before Interest, Tax, Depreciation and Amortisation) of Rs 905 crore for the June quarter, 25 percent higher than what was reported during the corresponding quarter last year. The EBITDA percentage was 22.7 percent.

"The paid-up equity share capital stands increased to 161.17 crores (80.58 crores equity shares of Rs 2 each) upon allotment of 1.27 lakh equity shares of ` 2 each pursuant to "ESOS 2013-A" during the quarter ended June 30, 2019," Cipla said in a regulatory filing.

"We witnessed a muted first quarter in FY20 owing to a combination of external volatility and some conscious business decisions taken with the long-term sustainability in mind. Our secondary growth in our flagship therapies in India and in the South Africa private market remained impressive, and our base business in the US saw y-o-y growth with increased revenue from recent high-value launches," said Cipla MD and Global CEO Umang Vohra.

"Our business fundamentals remain strong, and our overall base business profitability was maintained at healthy levels despite the volatility. Our growth drivers remain on track with sustained expansion of our basket of biosimilars in emerging markets, entry into new markets such as China to set up our respiratory franchise, and further depth in our U.S. specialty pipeline with ZEMDRI," Vohra further added

Morevoer, Cipla Ltd signed a definitive agreement to acquire the minority stake of Eight Roads in Cipla Health Limited (CHL). Eight Roads had acquired minority ownership in CHL through two rounds of investment in April 2016 and August 2018. The latest deal will grant Cipla Ltd 100 percent ownership interest of CHL.

Cipla shares closed at 519 on BSE, registering a gain of 18.80 points or 3.76 percent, after making an intraday high of 525.05 (4.97 percent).
Syngene, through Biocon Foundation, Narayana Health & Agastya International Foundation launch CHAMPS Initiative

Bangalore, India: Syngene International in association with Narayana Health, Agastya International Foundation, and Biocon Foundation has launched CHAMPS (Child Health Activists Mentoring & Promoting Heath in Society). This is a student mediated initiative focused on preventing and managing early onset of noncommunicable diseases (NCDs).

The initiative, currently rolled out as a five-month pilot, is intended to be a three-year program to educate students in prevention and management of early onset of NCDs and promote healthier lifestyle.

In India, 60 percent of all fatalities are caused by NCDs: type 2 diabetes, cancer, heart, and respiratory diseases. Studies conducted across India reported high prevalence of hypertension with little to no awareness and control. The Fourth National Family Health Survey evaluated and reported hypertension in 207 million people (men 112 million, women 95 million). CHAMPS will address this public health issue of hypertension through 8th and 9th standard students trained to screen for these symptoms within their community.

The combined synergies of Narayana Health as knowledge partner, Syngene and Biocon Foundation as funding partners, and Agastya International as the implementation partner will ensure greater awareness in the involved communities. The training modules are tailored to comprehension levels of students who have been enrolled; and are designed to create awareness on hypertension and training them in the use of the Blood Pressure apparatus.

Kiran Mazumdar Shaw, Managing Director, Syngene International Ltd, in light of the initiative, said, "As indicated in the 'Hypertension in India' report by National Centre of Biotechnology and Information (NCBI), the number of fatalities in India, due to hypertension, has risen and the states with greater urbanization, human and social development have greater incidence. Through the CHAMPS, we shall engage high school students as change agents, by training them to screen for symptoms, record blood pressure readings and share it with relevant authorities. This will enable monitoring of NCDs in communities for corrective actions to be implemented."

The aim of Champs program is two-fold. First we would like to detect high BP at early stage to prevent future complications by appropriate treatment. By training high school students to record BP we are introducing passionate young kids to the world of medical profession and change the way healthcare is delivered globally," said Dr. Devi Shetty, Chairman and Executive Director, Narayana Health.

According to Ramji Raghavan, Founder Chairman, Agastya Foundation, the fundamental idea of the CHAMPS initiative of developing children as change agents in raising awareness of one of the NCDs, namely hypertension, ties in well with Agastya's philosophy of developing children as young instructor leaders, who are change agents imbibed with a scientific temper.

"This health awareness programme will be imperative in creating the much -required health awareness among the younger generation, giving them a sound body to harbour a sound mind. This will in return strengthen our nation and help in building a healthier future", said R Umashankar, Principal Secretary, Karnataka Education Department.
Eversana Expanding their Business in Asia Pacific region

Chicago, USA: Eversana, a leading independent provider of global commercial services to the life science industry, announced the rapid expansion of its Asia Pacific business with the addition of two new offices in Singapore and Mumbai. The announcement came as the company appointed a regional leadership team to be based in Singapore to drive the company's growth and ensure client service.

Eversana offers a fully integrated and independent commercial service platform designed to solve patient support, distribution, field force, compliance, and marketing challenges in the life science sector. As the Asia Pacific market grows, there is an increased need for global solution capabilities for companies headquartered in the area or aiming to expand in the region, as well as US and European headquartered companies looking to bring solutions to the APAC markets.

"China and Japan are now the second and third largest life science markets; and are widely regarded as vital contributors to the future of precision medicine," said Jim Lang, CEO, Eversana. "We recognize that a thriving global life science sector requires a commercial service platform that not only adds value at every stage of the product lifecycle, but also understands the unique business, regulatory and cultural intricacies of our global marketplace."

Worldwide, Eversana has more than 2,000 employees working from 25 locations, including offices in North America, Europe, and Asia. Eversana plans to invest significant capital resources to build its regional footprint and support talent development. The company expects to open offices in Shanghai and Tokyo by the end of 2019.

"For ourselves and our customers, it's not just an economic opportunity, but rather a moral imperative to bring these life transforming therapies to patients located in this region," added Lang.
Pumas-AI Introduced Healthcare Software for Researchers & Clinicians

Maryland, Bultimore: Pumas-AI, a new University of Maryland, Baltimore (UMB) startup company established by University of Maryland School of Pharmacy (SOP) faculty members Vijay Ivaturi, PhD, Assistant Professor, and Joga Gobburu, PhD, MBA, professor, has released its first, cuttingedge software platform for pharmaceutical researchers and clinicians.

Known as Pharmaceutical Modelling and Simulation (Pumas), the software was developed at UMB through a partnership with experts at Julia Computing. Software development efforts have been led by Christopher Rackauckas, PhD, senior research analyst in the SOP Department of Pharmacy Practice and Science, with significant input from independent contributor Joakim Nyberg, PhD, of Uppsala, Sweden.

Pumas is a copyrighted, comprehensive platform based on the Julia programming language that contains multiple modules designed to meet the needs of analysts in the pharmaceutical industry, while also working to advance therapeutic innovation in the clinic setting.

"The success rate for pharmaceutical innovations is approximately two percent," said Gobburu, who, in addition to his role in the Department of Pharmacy Practice and Science, also serves as Executive Director of the Center for Translational Medicine (CTM) at the School of Pharmacy. "Pumas software is tailored to revolutionize big data analytics in health care, unlike those tools used in other fields. By combining the extensive health care knowledge of our faculty and staff with the scientific computing experts at Julia Computing, we have developed a tool that will not only benefit business leaders working in the pharmaceutical industry, but also those who are caring for patients on the frontline of health care delivery."

"Moving technologies with commercial potential, such as Pumas, into the public sector is an important aspect of what universities do," said Phil Robilotto, UMB Associate Vice President, Office of Technology Transfer, and Director of UM Ventures, Baltimore. "This innovative health care data software created by SOP’s scientific team is a big success for UMB and will be incredibly beneficial to the public as it's further developed.”

The Pumas software platform, licensed from UMB, is the first product released by Pumas-AI, whose goal is to double pharmaceutical and patient care success rates by democratizing tools and education in the health care data analytics space. Pumas provides a wide range of analytic capabilities for pharmaceutical and biotechnology development, as well as therapeutic decision making - addressing a crucial need for pharmaceutical companies and investors, who often base their decisions on a combination of technical, regulatory, and commercial success probabilities, all of which the Pumas software can provide quantitatively.

"Pumas is our company's first product specifically designed for professionals in the pharmaceutical and health delivery sectors to bridge this gap," said Gobburu . "It leverages the Julia programming language, and combines modern artificial intelligence (AI) with traditional mechanistic models, allowing the CTM to foster one of its goals of enhancing real-world data analytics."

Julia was selected for its speed and succinctness as a programming language, which produces an interface that looks similar to R, but operates at the speed of FORTRAN. Because Pumas is created entirely in Julia, users can make direct use of the language's database, statistics, and visualization functionality - all without losing performance. Pumas was released in July in conjunction with a Julia language conference hosted by UMB.

"Pumas is the first pharmaceutical modeling suite that is designed from the ground up to be used with modern graphics processing unit (GPU) hardware and parallelized stiff differential equation solvers. It also allows for integration of machine learning with pharmacometrics, enabling a new kind of science known as scientific machine learning or scientific AI," says Rackauckas. "We are excited to not only accelerate current workflows, but also help users explore the new, realistic models that are enabled by this technology."

In addition, Julia is the programming language of choice for prominent researchers who work on projects at the cutting edge of machine learning as well as in differential equations research, which means that, unlike many other tools , Pumas has the unique ability to directly incorporate modern techniques to achieve maximal efficiency and accuracy.

"At the CTM, we strive to develop point-of-care solutions for providers and clinicians that can help individualize treatment for patients," said Ivaturi, who also serves as a pharmacometrician in the CTM at the School. "The Pumas software platform will be instrumental in helping us optimize treatments for a number of conditions and therapeutics."

He adds, "It is going to revolutionize therapeutic decision making and allow health care organizations to benefit from payor incentives by demonstrating substantial improvements to successful patient care."
Unichem Laboratories Received USFDA Nod for Hypertension Management Drug

Mumbai, Maharashtra: Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.

The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing.

The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

As mentioned by the spokesperson of Unichem Laboratories, Hygroton tablets are indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, corticosteroid, and estrogen therapy, and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Unichem said the product will be commercialised from its Ghaziabad plant.
Cadila Pharma Bagged TISS LeapVault CLO Awards in Two Categories

Ahmedabad, Gujarat: Cadila Pharmaceuticals has bagged two TISS LeapVault CLO awards under the categories of Program for Sales Enablement and Social Media Based Learning Program. Tata Institute of Social Science-Leapvault CLO Summit and Award brings together leaders from human resource, corporate learning, coaching, organisation and leadership development. This award was conferred on the Learning and Development (L & D) team of Cadila Pharma for their initiative of training the field force using WhatsApp.

Cadilas L & D team thought of an idea of using the existing platform of Whatsapp to increase their reach. Hence, the team merged e-learning with social media for the training of the field force. The L & D team of Cadila Pharmaceuticals began its training program in January 2019. The objective of the training is to build customer-centric capabilities of its diversified field force using new-age learning tools. The company adopted a mix of classroom teaching and e-learning using WhatsApp as a tool to ensure the application of the key learnings.

The L & D team trained 1,999 employees across 13 locations in ten days. For the remainder of the training program, the team used WhatsApp to ensure a regular connect was maintained with the teams. Through innovative weekly campaigns of selfies, audio and video clips to ensure the application of the learning, which included grooming, interpersonal skills, and communication.

Dr. Sunil Singh, the Chief Human Resource Officer of Cadila Pharmaceuticals, and Ajay Tyagi, Chief Learning Officer of Cadila Pharma were the brains behind this creative solution. "We observed 30 percent adoption among our colleagues, which is higher than the standard 20-25 percent usually seen in e-learning. This initiative is one more step towards our vision of becoming a progressive, transformative, and a caring organization", Dr Singh said in a statement.

This recognition comes recently after two awards won by Cadila Pharmaceuticals for the Best Warehouse Workforce Award at the Second Annual Future Warehouse Summit Awards 2019 in the month of July 2019 and a WorldStar Packaging Award in May 2019.

Cadila Pharma has been making bold moves to ensure a culture of excellence. With multiple initiatives like four-day summer break, leave on first Saturdays and flexi timings, Cadila Pharma has remained committed towards breaking the age-old practices of manufacturing industry.
Shimmer Won Two GHP International Life Sciences Awards for its Wearable Sensor Technology

Staffordshire, United Kingdom: Shimmer Research, a global leader in wearable technology for research applications, announced that it has been honored with two GHP International Life Sciences Awards - Best Clinical Trials Wearable Sensor Technology Company USA, and Best Researcher Wearable Wireless Technology Provider 2019.

Shimmer was recognized for its verisense wearable sensors platform, which was designed from the ground up for clinical research; its NeuroLynQ consumer neuroscience platform, which uses scientificallyvalidated galvanic skin responses (GSR) to monitor an audience's emotional response to stimuli; and its Shimmer3 sensor platform, which records additional biometric measures, such as electrocardiography (ECG) and electromyography (EMG).

"For more than 10 years, Shimmer has been a wearable sensor leader in the academic and corporate research markets, most recently with our Shimmer3 platform," said Geoffrey Gill, President of Shimmer Americas. "We are very grateful for the thousands of researchers around the world who have developed innumerable algorithms to interpret wearable sensor data. During the past two years, we have leveraged that experience to develop highly tailored offerings for the clinical research and consumer neuroscience markets. We are delighted to receive these two GHP International Life Sciences Awards for our wearable sensor. It is welcome recognition that we have 'hit the mark' with our new developments."

Verisense was designed specifically to meet the specialized needs of clinical research, including improving data quality, while reducing burden on sponsors, sites, and participants. Sponsors gain access to secure raw participant data, which are validated using built-in algorithms. They also receive a dashboard that displays the status of the entire study at a glance, and allows drill down to individual sensors. Site setup takes five minutes and system alerts flag any issue that arises during the study in real time. Verisense sensors are also easy for participants to use; they can just put them on and forget about them. They can be worn all the time, even in the bath or shower, the battery lasts for up to six months, and data transfer is completely automatic. The Verisense platform can monitor up to seven sensors on a participant's body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as Parkinson's disease or epilepsy.

Designed for consumer neuroscience applications, NeuroLynQ allows an audience's emotional response to be measured objectively in real time in a real-world setting using GSR. It has been used to measure audience reactions to events as diverse as the Super Bowl and a classical music concert. It can also evaluate audience response to new marketing or advertising material. It takes only a couple of minutes for audience members to learn how to put on the NeuroLynQ sensor and the platform can provide results from up to 45 people simultaneously in a format that is easy to use and interpret.

Shimmer's wearable sensors have gained widespread market acceptance because they are easy to use, reliable, and provide high quality, validated data. The company also ensures that its technology continues to evolve to meet changing market needs. Underscoring the popularity of Shimmer sensors, they are also used by more than 20 original equipment manufacturers in their products and services.
Piramal's Pharma Business Has Grown over 10 percent to 4,786 Crore in FY19



Mumbai, India: Over 90 percent of Piramal's Pharma revenues derived from niche businesses of complex generics and Contract Development and Manufacturing Operations (CDMO).

This is in stark contrast to most large Indian Pharma companies that have less than 5 percent of its business in these categories, opting for the large volume generics business.

Commenting on this growth, Mr. Ajay Piramal, Chairman, Piramal Enterprises states that "Our differentiated business model in Pharma has enabled sustained revenue growth despite pricing pressures and regulatory concerns that impacted the industry. During the year, our Pharma business grew 11 percent y-o-y to 4,786 crores. The margin profile for this business has improved significantly, over the last few years. Global Pharma business EBITDA crossed 1,000 crores in FY2019, with EBITDA margins at 23 percent in FY2019 as compared to 10 percent in FY2011."

The business has completed 70 integrated projects of which 28 were completed in FY2019 alone.

Piramal Pharma Business has expanded its offering with integration of key acquired products from Janssen, launch of Sevoflurane Integrated Closure variant Miglustat in select European markets and MITIGO introduced in the US. The OTC business has also expanded with a Direct reach to ~4.2 lakh outlets.

Pharmaceutical business had a challenging regulatory environment. Piramal focused on quality control, regulatory compliance, and reliable customer service to maintain strong growth. Over the past few years, Piramal Enterprises Limited (PEL) has made significant investments in activating various growth levers, which are expected to drive the next round of growth for its Pharma business.