Moderna abandons mid-stage mRNA cancer asset in favor of similar triple-attack candidate Inspector general review of FDA's quick approval process won't take the accelerated pathway Bayer bets $1.5B that Vividion will help it target the 'undruggable' and make 1+1=3 Valneva, racing Merck for a priority review voucher, exceeds protection goal in phase 3 chikungunya vaccine trial PepGen raises $113M to challenge Sarepta in DMD, build neuromuscular and neurologic pipeline Gilead's Kite signs second blood cancer pact, this time with Appia Bio for up to $875M How a century-old tuberculosis vaccine may help fight severe COVID-19 WCG Clinical postpones massive IPO that sought $720M raise Synthetic biology outfit Zymergen sees fledgling stock tumble amid CEO departure, product delays How's Amgen's key KRAS launch looking? It's too early for meaningful sales, but expectations are riding high Thousands of patients were implanted with heart pumps that the FDA knew could be dangerous U.S. ranks last among 10 other countries in new study on healthcare systems Featured Story | By Annalee Armstrong Moderna has ditched a phase 2 asset in development for solid tumors, lymphoma and ovarian cancer to instead focus on a similar therapy that could put up a triple attack. The biotech, of COVID-19 vaccine fame, revealed in a second-quarter earnings release that the standalone OX40L candidate mRNA-2416 will be shelved in favor of mRNA-2752. read more |
| |
|---|
|
Top Stories By Kyle LaHucik As it goes with the federal government, the Office of the Inspector General said Wednesday it will review the FDA's accelerated approval pathway following a bevy of concerns regarding the agency's controversial green light to Biogen's Alzheimer's disease drug Aduhelm. read more By Kyle LaHucik Bayer's newly installed head of pharma R&D said it hasn't "delivered enough for patients yet," so the German Big Pharma is adding to its acquisitions of BlueRock and AskBio with the $1.5 billion purchase of Vividion Therapeutics, which earlier this summer contemplated going public. read more By Nick Paul Taylor A phase 3 trial of Valneva’s chikungunya vaccine candidate has induced protection in 98.5% of participants, hitting the trial's main goal and cementing the biotech’s lead over Merck in the race to develop a product to prevent the viral disease. read more By Nick Paul Taylor PepGen has raised $112.5 million to take a treatment for Duchenne muscular dystrophy into the clinic early next year. The crossover round positions PepGen to start showing if its technique for getting more oligonucleotides into cells can improve on the efficacy of Sarepta’s Exondys 51. read more By Kyle LaHucik Gilead's Kite is helping Appia Bio fly a little higher with a blood cancer research and development deal that could be worth $875 million if the wind blows in the right direction. The Culver City, California-based biotech will lead preclinical and early clinical research on two off-the-shelf cell therapies. read more By Angus Liu A research group in India has found that the century-old tuberculosis vaccine BCG may have potential for controlling severe COVID-19 in elderly patients by reducing blood levels of proinflammatory cytokines. It's not the first time scientists have proposed repurposing BCG in other diseases. read more By Kyle LaHucik WCG Clinical had hoped for $720 million in proceeds from its Thursday debut on the Nasdaq. The nine-year-old company instead chose to postpone its initial public offering. read more By Conor Hale Just months after going public through a $500 million IPO, the company disclosed severe setbacks in its commercial pipeline, erasing its chances of making money this year and projecting “product revenue to be immaterial in 2022.” read more By Eric Sagonowsky It’s only been about two months since Amgen’s hot new KRAS inhibitor Lumakras won FDA approval, but it’s clear the drug is already shouldering big expectations. While the company didn't yet report sales for the new med, Amgen execs shared details about other metrics and said they're excited about the med's prospects. read more By Neil Bedi, ProPublica Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts. read more By Anastassia Gliadkovskaya In a new international study, the U.S. ranked last in four of five categories studying equitable, affordable and good quality healthcare. read more | | With the expansion of its DNA services, Cobra Biologics, a Charles River company, has capacity to offer rapid 6-week delivery of HQ plasmids as starting material for clinical evaluation of viral vector mediated immunotherapies. 2021 slots available. |
Resources Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. 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. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Diversity, Equity & Inclusion Week August 9-11, 2021 | Virtual Event Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA | 