PHARMACY MARKET

Lubrizol Life Science Launches Advanced, Natural Nutraceutical Solution to Support Mental Agility

Lubrizol Life Science | October 28, 2020

Lubrizol Life Science Health (LLS Health) launches ASTAGILE™ microcapsules, its new sustainable, organic-certified, astaxanthin (Haematococcus pluvialis), microencapsulated with spirulina. The two ingredients have been uniquely combined in a patent-pending product designed to promote mental agility and support healthy ageing for young and senior adults. Astaxanthin is a carotenoid found in freshwater microalgae, and spirulina is a type of algae. Both have numerous health promoting effects. To create the synergistic algae blend, LLS Health teamed with Neoalgae Micro Seaweeds Products, SL, a research and development company in Spain dedicated to microalgae biotechnology.

Spotlight

"A new report published by the Tufts Center for the Study of Drug Development (CSDD) pegs the cost of developing a prescription drug that gains market approval at $2.6 billion, a 145% increase, correcting for inflation, over the estimate the center made in 2003."

Spotlight

"A new report published by the Tufts Center for the Study of Drug Development (CSDD) pegs the cost of developing a prescription drug that gains market approval at $2.6 billion, a 145% increase, correcting for inflation, over the estimate the center made in 2003."

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BUSINESS INSIGHTS

Applied BioMath, LLC Announces Collaboration with BYOMass™ for Systems Pharmacology Modeling in Oncology

Applied BioMath | October 18, 2021

Applied BioMath, the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, today announced a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases. BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily. "We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms, We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies." - Margaret Jackson, D.Phil., Founder and CEO of BYOMass Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class, We look forward to collaborating with BYOMass and helping them decide next steps for this project." - John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. About Applied BioMath Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic.

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PHARMA TECH

PharmaJet partner Zydus Cadila Announces COVID-19 Vaccine Expansion Plan to Multiple Countries With Korean Firm

PharmaJet | January 05, 2022

PharmaJet®, the maker of innovative, needle-free injection technology, announced that its partner Zydus Cadila, is partnering with Enzychem Lifesciences to manufacture their COVID-19 plasmid DNA vaccine in Korea. The plan is to manufacture 80+ million doses of the ZyCoV-D vaccine, which was recently granted emergency use approval by India’s national regulatory agency for those aged 12 years and above. The vaccine will be manufactured in Korea and exported to several lower-middle income countries in Latin America and Asian New Southern Policy member countries. It is exclusively delivered by the PharmaJet Tropis® Needle-free Injection System. Under the terms of this agreement, Zydus will transfer its manufacturing technology and provide technical assistance to Enzychem Lifesciences. The vaccine is administered intradermally using the PharmaJet needle-free system, which can be deployed more readily, especially in resource-poor populations where these are urgently needed. “This manufacturing agreement will enable people in lower-middle income countries access to a safe, well-tolerated and efficacious vaccine, delivered by a proven delivery system. Our systems have been successfully used to deliver millions of doses for polio immunization initiatives in Pakistan, Somalia, The Gambia, and numerous other countries. We are prepared for this commercialization initiative and have scaled our operations to meet the demand driven by COVID-19 vaccinations as we continue to fulfill our company mission of improving peoples’ lives through our needle-free delivery technology.” Chris Cappello, President and CEO of PharmaJet About PharmaJet PharmaJet’s mission is to improve people’s lives through needle-free technology. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. About Enzychem Headquartered in Seoul, South Korea, Enzychem Lifesciences is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Enzychem lead candidate, EC-18, has successfully completed US FDA phase 2 clinical testing in cancer patients. In response to the Korean government pledge for a Vaccine Hub, Enzychem has formed a consortium with Hanmi Pharma and several domestic companies in Korea to manufacture vaccines against COVID 19. The company plans to leverage its expertise in lipid chemistry and manufacturing to establish itself as a regional producer of lipid-based formulations for improved delivery of nucleic acids and other biologicals and drugs. About Zydus Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 23,000 people worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating healthier communities globally.

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BUSINESS INSIGHTS

InDex Pharmaceuticals strengthens the clinical development organization in preparation of the start of the phase III study CONCLUDE with cobitolimod

InDex Pharmaceuticals | August 23, 2021

InDex Pharmaceuticals Holding AB today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod. Anders Bröijersén is joining InDex as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Anders Bröijersén is a medical doctor and PhD with 15 years of experience in Clinical Development, Medical Affairs and Drug Safety at leading pharmaceutical companies such as Boehringer Ingelheim and MSD. Anders joins InDex from Sobi where he currently serves as Medical Director, Global Pharmacovigilance & Patient Safety. Johan Levin is a trained nurse and has more than 20 years of experience in Clinical Development at leading pharmaceutical companies and clinical research organizations (CROs) such as MSD and Covance. He currently works as senior Clinical Research Associate (CRA) at PRA Health Sciences. "I am pleased that InDex has been able to attract two highly qualified new employees and welcome Anders and Johan to the team," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are expanding the organisation in preparation of the start of our global phase III study CONCLUDE with cobitolimod to be able to be active towards the study sites in collaboration with our CRO. This was a successful model for patient recruitment in our previous study CONDUCT." The phase III study CONCLUDE with cobitolimod will include 440 patients and be conducted at several hundred clinics in over 30 countries. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. Cobitolimod Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study. InDex Pharmaceuticals InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company's lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.

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