Biopharma R&D 'surged' in 2020, but trial productivity levels a mixed bag: report CytoDyn begs investors to stop trashing FDA in bizarre call after agency's public smackdown Romano swiftly exits as CMO of gene therapy startup Passage Bio Novartis loses another NIBR exec as neuro expert Shanker joins a gene therapy biotech Sarepta shares rally on early DMD data that also reveal 2 serious, 79 mild side effects BerGenBio fails COVID-19 trial, makes post hoc case for program Cancer trials not hit by COVID chaos as bad as first thought, but other tests are suffering: Nature report Featured Story | By Ben Adams A major global pandemic was not enough to stop surging rates of biopharma research and development, but trial productivity still remains below the long-term average. read more |
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Top Stories By Annalee Armstrong CytoDyn President and CEO Nader Pourhassan begged his investors to stop trashing the FDA after the agency issued a rare public rebuke over the company’s public statements on a pair of failed COVID-19 clinical trials. “You can throw all kinds of eggs and tomatoes, whatever you like, at me. I deserve it,” Pourhassen said. “But please don’t do that to the regulatory agency.” read more By Nick Paul Taylor Gary Romano, M.D., Ph.D., has left gene therapy startup Passage Bio with immediate effect. The biotech and its chief medical officer “mutually agreed” they should part company Tuesday, and Romano left the same day. read more By Kyle LaHucik Novartis Institutes for Biomedical Research is bleeding leaders as a third in as many weeks exits the door to lead Tevard Biosciences into the clinic. read more By Annalee Armstrong Two weeks after Sarepta reported a new safety concern in a Duchenne muscular dystrophy clinical trial, the company says another gene therapy candidate has shown some early success and will be brought to the FDA for permission to kick off further testing. read more By Nick Paul Taylor A phase 2 clinical trial of BerGenBio’s bemcentinib in hospitalized COVID-19 patients has missed its primary endpoint. The AXL inhibitor failed to accelerate time to sustained clinical improvement over standard of care, but BerGenBio identified a subgroup analysis of a secondary endpoint as a reason to continue development. read more By Ben Adams Cancer trials saw the most disruption in early summer of last year amid the first wave of the pandemic but were swift to get back on course. read more | | LabConnect is the leader in innovative central laboratory services for cell and gene therapies. Far more than typical central laboratory support, only LabConnect offers comprehensive, specialized services customizable to meet the unique needs of your complex clinical trials. Connect with us today. |
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