Today's Rundown GSK makes adjuvant available to coronavirus vaccine project Gilead climbs as coronavirus drug shows efficacy, starts trial Insmed’s inflammatory lung disease drug makes the grade in phase 2 Boston Pharmaceuticals nabs Novartis veteran as new CMO Aerie Pharmaceuticals hires former Allergan, Alcon exec to help lead clinical, medical affairs FDA clears Sony's surgery video-sharing platform Catalent laying out $315M to snatch another gene therapy CDMO Featured Story | | | Monday, February 3, 2020 GlaxoSmithKline has agreed to make its adjuvant technology available to the Coalition for Epidemic Preparedness Innovations’ effort to create a prophylactic against the coronavirus radiating out from China. |
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Top Stories Monday, February 3, 2020 Gilead has made progress in its effort to reposition failed Ebola drug remdesivir as a treatment for the coronavirus sweeping across China. In quick succession, it emerged that the nucleotide analogue prodrug appeared to help the first U.S. case of the virus and is set to undergo clinical testing in China, sending Gilead’s stock up by as much as 13% in premarket trading. Monday, February 3, 2020 In 2016, Insmed bet $30 million on a pulmonary drug from AstraZeneca. Now, that bet looks to be paying off as the New Jersey biotech reports positive topline data in a phase 2 study of non-cystic fibrosis bronchiectasis (NCFBE), a chronic condition in which the bronchi are damaged from a cycle of infection and inflammation. Monday, February 3, 2020 Boston Pharmaceuticals has grabbed a former high-ranking and longtime Novartis research executive as its new chief medical officer. Monday, February 3, 2020 Michelle Senchyna, Ph.D., has been named as the new vice president for clinical development and medical affairs at eye disorder biotech Aerie Pharmaceuticals. Monday, February 3, 2020 Multinational conglomerate Sony has received a clearance from the FDA for its digital workflow collaboration platform for hospital operating rooms and catheter labs. Monday, February 3, 2020 Catalent, which carved out a place in gene therapies with its $1.2 billion Paragon Services deal, is adding another serving to its operations. It will pay $315 million for Masthercell Global, a Belgium-based cell and gene therapy CDMO with operations in Europe and the U.S. Resources Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 