FDA stops all Allogene's CAR-T trials over safety scare, raising questions about future of gene editing Mirati, Sanofi join forces in lung cancer with a KRAS-SHP2 combo approach Takeda's transplant drug gets unanimous support of FDA AdComm despite concerns over diversity of its study Sponsored: The Role of Quality and Speed in Custom Model Generation No sweat for Brickell: the biotech will submit its gel for FDA approval with 2 positive phase 3 trials Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform Pfizer, Bayer-backed Pyxis ups IPO price as biotech's public run continues unabated Novel vaccine strategy protects mice from COVID-19 and 4 related coronaviruses White House funnels $1B into at-home COVID test makers, quadrupling monthly supply by December New FDA chief set to be nominated by Biden, 9 months into his tenure Fierce Pharma Asia—Takeda's narcolepsy trial problem, gene therapy pact; human error in Moderna's COVID vaccine Chutes & Ladders—Pfizer's development leader is retiring in early 2022 Featured Story | By Nick Paul Taylor The FDA has sent shockwaves through the off-the-shelf CAR-T space, slapping a clinical hold on all of Allogene Therapeutics’ AlloCAR T clinical trials in response to an abnormality that could theoretically cause cancer. read more |
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Top Stories By Ben Adams Mirati may have been beaten to the punch by Amgen after it nabbed a speedy FDA approval for its KRAS drug Lumakras this year, but it’s still pushing to try to wring the most efficacy out of its rival therapy. read more By Nick Paul Taylor Takeda’s faltering effort to deliver a wave of new products that will drive sales growth over the next decade has received a boost. Having seen its other prospects stumble in recent months, Takeda got back on track with unanimous FDA advisory committee votes in favor of a transplant drug. read more Sponsored By: Taconic Biosciences Pressure to get results in drug discovery and development is unprecedented and the need for genetically engineered custom mouse models is greater than ever. Innovative thinking is getting these critical models into researchers hands faster. read more By Kyle LaHucik Brickell Biotech reached statistical significance on all measures for both of its pivotal late-stage studies of a sweat gel. That gives the Colorado biotech the confidence to ask the FDA for approval in mid-2022. read more Sponsored by: Almac Group PanCan utilised Almac's IRT expertise to accelerate their adaptive platform outcomes and improve patient care. Find out how here. read more By Ben Adams As a barometer of the rude health biotechs continue to find themselves in on Wall Street, Big Pharma-backed oncology player Pyxis Oncology is upping its IPO. read more By Arlene Weintraub Scientists at Osaka University set out to develop a universal vaccine that targets the "core" region of the coronavirus' spike protein receptor-binding domain, which is similar among all related viruses. They engineered antibodies that protected mice against COVID-19 and four other coronaviruses, they reported in a new study. read more By Andrea Park The billion-dollar investment is estimated to quadruple the total number of at-home, rapid tests available to Americans by December. Beginning that month, that number will reach 200 million tests per month, which will be available for purchase and distribution by government entities, employers and consumers alike. read more By Kevin Dunleavy After nearly nine months without a permanent FDA leader and after watching the agency withstand a torrent of criticism, President Joe Biden finally ready—almost—to announce a nominee for the beleaguered agency. read more By Angus Liu Takeda halted two trials for a narcolepsy candidate to examine a safety signal. The Japanese pharma also signed a gene therapy pact potentially worth over $1 billion with Selecta Biosciences. Moderna has identified "human error" as the source of contaminations in its halted COVID-19 vaccine doses in Japan. And more. read more By Kyle LaHucik Pfizer's chief development officer, Rod MacKenzie, is the Big Pharma's second executive to retire in early 2022. NIH Director Francis Collins will also hit the exit, before the end of this year. Sanofi poaches Gilead cancer executive Valeria Fantin to run its oncology research. read more Resources Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. 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