FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test Biogen, with sales falling sharply, posts 'obviously disappointing' Aduhelm sales of $300K, CEO Vounatsos says White House says it's prepped to deliver millions of kids' COVID vaccines to pediatricians, children's hospitals, pharmacies Medtronic issues EU safety warning for Percept PC deep brain stimulation implant Novavax struggling to meet quality standards in COVID-19 vaccine production push: report F-star shoots for the moon with massive $1.35B J&J biobucks deal for 5 bispecifics Pfizer strong-armed governments in COVID-19 vaccine supply talks, report says Drug overdoses surged during the pandemic. Providers are thinking outside the box to combat the opioid crisis Abbott's COVID test sales make comeback thanks to delta-driven demand Princeton and MIT gene-editing pioneers uncover clues for improving CRISPR and other tools Stealth's not so sneaky strategy to file unprepared drug application foiled by FDA HLTH21: Blue Shield of California, Google Cloud team up to take on claims management NYU surgeons successfully transplant kidney from genetically modified pig into human patient Featured Story | By Ben Adams We found out, via a small and almost unnoticed ClinicalTrials.gov update today, that AstraZeneca suspended trial work on its experimental blood cancer drug AZD5991. Now, we have learned that things are in fact bleaker for the therapy. read more |
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Top Stories By Kevin Dunleavy Biogen sales were sliding ahead of the controversial approval for Alzheimer's drug Aduhelm. On Wednesday morning, Biogen revealed a stunning number—$300,000—in third-quarter sales for the medicine, once hailed as a first-of-its-kind breakthrough drug. read more By Dave Muoio The Biden administration that it has secured enough shots for all 28 million U.S. kids ages five to 11 and, contingent on regulatory authorization, will work with tens of thousands of providers and community organizations to put shots in arms. read more By Andrea Park Medtronic identified an issue in which its Percept PC deep brain stimulation implant may stop working and need to be removed after an implanted patient undergoes a cardioversion. read more By Joseph Keenan Novavax, which reaped $1.6 billion from the federal government last year to develop and manufacture a COVID-19 vaccine, is reportedly struggling to meet quality standards. read more By Kyle LaHucik Add Johnson & Johnson's Janssen Biotech to the list of Big Pharmas lining up at the doors of 2011 Fierce 15 winner F-star Therapeutics. The $17.5 million upfront, $1.35 billion biobucks pact grants Janssen an exclusive license to up to five novel bispecific antibodies. read more By Eric Sagonowsky Pfizer is playing a leading role in producing vaccines against COVID-19, but new documents released by Public Citizen shine a light on the company's aggressive tactics when negotiating supply deals. read more By Anastassia Gliadkovskaya Drug overdose deaths rose 30% in 2020. But experts say the U.S. lags in offering evidence-based treatment to address addiction. Fierce Healthcare spoke to providers who are trying to revolutionize the way forward. read more By Conor Hale After weathering a nearly billion-dollar dip in rapid COVID testing revenues earlier this year, Abbott’s BinaxNow antigen test sales rebounded following the COVID-19 resurgence due to the delta variant. read more By Angus Liu Scientists at Princeton and MIT, including gene-editing pioneer David Liu, used a new screening method called Repair-seq to identify pathways that affect different outcomes in CRISPR/Cas9, prime editing and base editing. The findings could help design more accurate and efficient gene-editing systems, they say. read more By Annalee Armstrong It was a bold strategy, filing a drug the FDA clearly said was not ready for prime time, but Stealth BioTherapeutics did it anyway. Today, its chickens have come home to roost. read more By Paige Minemyer BOSTON—Blue Shield of California and Google Cloud are joining forces to build a new, scalable cloud platform that aims to automate and simplify the medical billing process. read more By Andrea Park The kidney came from a pig that was genetically modified by United Therapeutics subsidiary Revivicor, which received FDA approval for its GalSafe pigs last year. read more |
