Featured Story By Annalee Armstrong Agenus’ cervical cancer drug balstilimab seemed on its way to FDA approval, but the biotech is now pulling the application after the agency granted full approval to Merck’s Keytruda in the same indication. Agenus Chairman and CEO Garo Armen, Ph.D., has urged the FDA’s Richard Pazdur, M.D., to intervene and allow the company’s therapy to be reviewed under the accelerated pathway, according to a document seen by Fierce Biotech. read more |
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Top Stories By Kyle LaHucik Athira CEO Leen Kawas altered images in research she conducted while a graduate student at Washington State University in the early 2010s. The altered research did not impact Athira Pharma's lead candidate, but the CEO is officially out after an independent investigation, and COO Mark Litton will replace her. read more By Kyle LaHucik Repeat biotech founder and MIT professor David Sabatini is biting back against sexual harassment claims that led to his ouster at the Whitehead Institute in August. In a lawsuit filed this week, Sabatini claims the allegations were false and is requesting damages. read more Sponsored by: Q2 Solutions Clinical lab testing at home - fact or fiction? Many operational and patient-related considerations must be taken when using a decentralized approach to specimen collection at or near the trial participant's home. read more By Ben Adams Metacrine is dumping work on an experimental fatty liver disease drug program after a phase 2 mixed bag result, resetting its clinical focus for the drug and also investigating a potential safety issue. read more By Ben Adams After launching last year and swiftly grabbing a Takeda deal, European Treg biotech Egle Therapeutics has bulked up its coffers with a 40 million euro ($46.4 million) funding round. read more By Kyle LaHucik A computational analysis concluded that two investigational cancer drugs might have promise in treating the lung disease pulmonary hypertension. That's the result of a study done by researchers at University of Pittsburgh School of Medicine and Prairie View A&M University, who believe the same technique could be used to repurpose cancer drugs for the treatment of many other diseases. read more By Rebecca Torrence SonderMind, the therapy matchmaker that hit unicorn status earlier this year, has acquired machine-learning company Qntfy to bring predictive analytics to mental health care. The startup said the acquisition will help providers on its platform deliver personalized, data-driven care to their patients. read more By Andrea Park In a dream come true for kids, rather than dissuading their pediatric patients from watching too much TV, physicians may now actually prescribe screen time as part of a therapeutic regimen. read more By Angus Liu China's Hansoh Pharma inked two siRNA partnerships. Johnson & Johnson intends to roll out a tailored patient support program for Legend Biotech's upcoming CAR-T therapy. Brii Biosciences' COVID-19 antibody combo could be a blockbuster opportunity, one analyst said. And more. read more By Kyle LaHucik Athira Pharma's CEO resigns after investigation confirms she altered research during graduate school. vTv Therapeutics named healthcare investor Deepa Prasad its new CEO and president. Opus Genetics snagged a new chief scientific officer and chief operating officer. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific 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. Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. |