Perlmutter steps down as Merck R&D lead as early research chief Li steps in Mesoblast hit by FDA rejection, request to run another trial GSK's ex-vaccine, pharma lead jumps ship to run G1 Therapeutics FDA lifts clinical hold on Solid Bio gene therapy trial Synthetic Biologics cans phase 2 IBS trial deemed likely to fail Ex-Ipsen boss de Garidel takes the helm at AZTherapies FDA authorizes oral rinse-and-spit test for COVID-19 Sixfold Bioscience snares U.K. grant to test cancer-fighting siRNA delivery system FiercePharmaAsia—CStone-Pfizer deal; Gilead's filgotinib nods; Takeda-Ovid epilepsy data Chutes & Ladders—Merck KGaA names insider Garijo as CEO in glass ceiling-busting promotion Featured Story | By Ben Adams After seven years running Merck’s R&D engine, much of which has revolved around cancer blockbuster Keytruda and, now, COVID-19 vaccines, Roger Perlmutter, M.D., Ph.D., is hitting the exit. read more |
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Top Stories By Nick Paul Taylor The FDA has issued a complete response letter to Mesoblast’s request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data. read more By Ben Adams Nearly two months after GlaxoSmithKline’s vaccine head left the Big Pharma in the middle of it making a pandemic shot, Jack Bailey has penned a deal to lead cancer biotech G1 Therapeutics. read more By Nick Paul Taylor The FDA has lifted the clinical hold on a phase 1/2 clinical trial of Solid Biosciences’ gene therapy treatment for Duchenne muscular dystrophy. Solid Bio secured clearance to resume dosing in the trial after making manufacturing changes to cut the number of viral particles given to patients. read more By Amirah Al Idrus Synthetic Biologics and Cedars-Sinai Medical Center are pulling the plug on a phase 2b study in irritable bowel syndrome because it’s unlikely to hit its primary objective. Cedars-Sinai, the sponsor, will do a “comprehensive review” of the data and publish the findings. read more By Amirah Al Idrus As Corvidia CEO, Marc de Garidel saw the heart disease biotech through a $2.1 billion acquisition by Novo Nordisk. Barely two months later, he’s back in the saddle, this time at AZTherapies, a company working on treatments for Alzheimer’s and other neurodegenerative diseases. read more By Conor Hale By swishing and gargling a small amount of solution for 30 seconds and then spitting it into a funnel and vial, the test both eliminates the need for a nasal swab and assists people who may have trouble in providing sufficient saliva for a direct test. read more By Fraiser Kansteiner Sixfold Bioscience snared an Innovate UK Smart Grant to run early tests on its targeted cancer drug delivery system. Set to run for 18 months, the project will yield a preclinical data pack to help Sixfold hustle its platform into the clinic, potentially by early 2022. read more By Angus Liu Pfizer injected $200 million into CStone Pharmaceuticals for exclusive local commercial rights to the Chinese biotech's PD-L1 agent. After an FDA rejection, Gilead's rheumatoid arthritis med filgotinib won a nod in Japan. Takeda and Ovid shared mixed data for a rare epilepsy med. And more. read more By Kyle Blankenship Merck KGaA names Garijo to top spot; Vico Therapeutics adds Bayer vet Sandbrink as CMO; TriSalus appoints Katz to chief medical role. read more Resources Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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