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 |
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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. |
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