FDA faces a reputation crisis amid Trump pressure for fast COVID action—and that's bad news for pharma FDA chief Hahn walks back plasma claims, but his correction still missed the mark, experts say Hospital operating margins down 28% through July: report Biogen conference likely linked to 'tens of thousands' of COVID-19 cases, researchers say Qiagen to launch digital, portable test for COVID-19 antibodies, preordering 900K for U.S. AstraZeneca is not involved in talks over emergency COVID-19 vaccine use: spokeswoman Biopharma roundup: FDA faces blood plasma backlash; Qiagen plots portable antibody test launch Healthcare roundup: CMS offering infection control training to nursing homes AstraZeneca starts phase 1 of antibodies that could protect against COVID-19 for 6 months In a COVID-19 twist, pharma's doc-rep relationships are actually improving: study Sutter Health posts $857M loss in first half of 2020 due to COVID-19 Mayo generates $154M in operating income in Q2 despite sharp drops in volume due to COVID-19 Medtronic reports 44% drop in quarterly income as it begins to recover from COVID-19 Science 37 teams up with ERT to tap into high-quality data from virtual trials Featured Story | By Beth Snyder Bulik The flip-flop emergency approval of convalescent plasma by the FDA sparked a social media wildfire of criticism—and cast a shadow on the agency’s reputation. Many criticized the FDA and Commissioner Stephen Hahn over the plasma EUA for COVID-19 patients and the appearance of President Trump's involvement. read more |
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Top Stories By Eric Sagonowsky As criticism of the FDA's convalescent plasma authorization mounted Monday, Commissioner Stephen Hahn, M.D., sought to clear the air. But his defense—and his attempt to correct a misplaced statistic—didn't sit well with some experts. read more By Tina Reed But remove the CARES Act funding from the equation and there's a much more "dire" situation driven by a devastating spring and sluggish return in patient volumes, according to Kaufman Hall's latest report. read more By Eric Sagonowsky It’s been some months since Biogen’s February management conference has been in the news, but as the pandemic drags on, researchers are now linking the early “superspreading event” with tens of thousands of cases in the U.S.—if not more. read more By Conor Hale Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes. read more By Eric Sagonowsky With leading COVID-19 vaccines already in efficacy testing, U.S. authorities are eyeing a possible emergency use authorization for AstraZeneca’s program before the election, the Financial Times reported Monday. But AstraZeneca hasn’t been involved in those talks, and the company says it's too early to speculate about a green light right now. read more By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner FDA Commissioner Stephen Hahn backpedalled claims on blood plasma's efficacy. Meanwhile, health experts blasted Hahn for "wasting trust" in the agency. Qiagen plans to roll out a digital antibody test before the end of the month. Medtronic's pandemic revenue slump is subsiding. Plus, doctor-sales rep relationships have grown amid the pandemic, a study found. read more By Healthcare Staff Follow along with the latest COVID-19 news straight from the Fierce Healthcare team. read more By Nick Paul Taylor AstraZeneca has started a phase 1 clinical trial of its two-antibody cocktail against COVID-19. The 48-subject trial is set to deliver data later this year and set AstraZeneca up to evaluate the protective and therapeutic effect of the drug in larger phase 2 and 3 studies. read more By Beth Snyder Bulik Among the many shifts wrought by the COVID-19 pandemic is the relationship between pharma sales reps and physicians. But that might be a good thing. A new Accenture study has actually found plenty of pandemic positives for pharma reps, including doctors with more time to learn about drugs and more inquiries on support services and financial help. read more By Robert King Sutter Health posted an $857 million loss in the first half of the year as operations hit a major decline due to the COVID-19 pandemic. read more By Robert King Mayo Clinic has weathered a sharp drop in patient volume to generate $154 million in net operating income in the second quarter of the year. read more By Conor Hale Over the past quarter, Medtronic’s net income dropped nearly 44% compared to the same period last year—but that still outpaced what many expected, considering the wide-ranging effects of the coronavirus pandemic. read more By Ben Adams Californian siteless trial specialist Science 37 is joining forces with trial data collector ERT to grab the same high-quality data in a virtual model as it would in a traditional model. read more | 