Merck cans both its COVID-19 vaccines due to weak clinical data Roche eyes FDA filing after bispecific matches Eylea again 2020’s top 10 clinical trial flops Faze Medicines nabs ex-Northern Biologics chief, Shire alum as new CEO After selling off most of the Vants, Roivant CEO Ramaswamy moves upstairs to executive chair TScan adds another $100M to the pot to as it plots new TCR cancer trials Aurinia snags FDA approval for lupus nephritis med Lupkynis, its first drug launch Gut bacteria point to novel strategies for combating asthma, COVID-19 FDA approves Boston Scientific's newest deep brain stimulator for Parkinson's disease Featured Story | By Nick Paul Taylor Merck has stopped development of its two COVID-19 vaccine candidates after getting a look at phase 1 data. The vaccine powerhouse said neither candidate triggered immune responses comparable to those achieved by rival jabs, leading Merck to cut its losses and focus on COVID-19 therapeutics. read more |
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Top Stories By Nick Paul Taylor Roche’s bispecific faricimab has matched Regeneron’s Eylea in another pair of phase 3 clinical trials. The top-line results suggest the VEGFxAng2 bispecific antibody faricimab performs as well as Eylea in people with “wet” age-related macular degeneration even when it is dosed half as often. read more By Phil Taylor While big companies can shrug off a failure, the wasted investment and missed commercial opportunities can still be damaging. For smaller companies, flunking a trial can jeopardize the future of the business. read more By Amirah Al Idrus Faze Medicines has a new CEO: Philip Vickers, Ph.D., a Shire alum who most recently led cancer-focused Northern Biologics. Vickers takes over from interim CEO Cary Pfeffer six weeks after Faze emerged with $81 million to pursue medicines targeting biomolecular condensates. read more By Amirah Al Idrus Roivant CEO and founder Vivek Ramaswamy is to become the biotech builder’s executive chairman as he promotes Chief Financial Officer Matt Gline to the chief’s role. There’s less to manage these days after Roivant sold off five Vants—Myovant, Urovant, Enzyvant, Altavant and Spirovant—to Sumitomo Dainippon, which now runs them under a new company, Sumitovant. read more By Ben Adams TScan Therapeutics has raised a cool $100 million in a series C to start 2021 on the positive notes it rang throughout 2020. read more By Beth Snyder Bulik Aurinia has nabbed its first FDA approval with an OK for Lupkynis (voclosporin) to treat lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus. And now it'll look to its newly bolstered commercial team to take the drug into a wide-open market. read more By Arlene Weintraub Australian researchers studied the microbiome in mouse models of asthma and were surprised to discover that the molecules L-tyrosine and p-cresol sulfate protected against lung inflammation. Now they're planning to fast-track L-tyrosine into clinical trials in asthma, and they believe it might also be effective against acute lung disease in COVID-19. read more By Conor Hale Boston Scientific has obtained approval from the FDA for the fourth generation of its Vercise Genus deep brain stimulation system, allowing conditional use while within an MRI scanner. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, “HQ” High Quality, GMP) manufacture. Now part of the Cognate BioServices family, Your CDMO partner from concept to commercial for cell & gene therapy products. Learn more. |
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Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Virtual Clinical Trials Summit February 9-10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved February 23-24, 2021 | 9:00am-3:30pm PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9:00am-3:30pm EST Learn what it takes to get a drug developed and approved March 9-10, 2021| 9:00am-3:30pm EST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 9:00am-3:30pm PST Learn the science driving biopharma. Specific for the non-scientist. May 6-7, 2021 | 9:00am-3:30pm EST | 