UPDATED: At the eleventh hour, Woodcock shunned by Biden as Califf becomes FDA commish nominee Majority of surgeons in new survey warn of longer wait times, care delays if Medicare cuts go through AstraZeneca wields ax, scrapping midphase programs from $1B takeover, Heptares pact in latest quarterly cull Recall of Ellume at-home COVID antigen tests grows to more than 2.2M kits GlaxoSmithKline, Vir target emergency authorization for intramuscular COVID-19 antibody drug with new trial win Johnson & Johnson to spin out consumer health business in new publicly traded company SITC: Cellectis' off-the-shelf CAR-T for pancreatic cancer and mesothelioma shows activity in mice Report: Nursing homes shed 221K jobs since start of pandemic while other sectors have recovered Abbott’s retrievable, leadless pacemaker clears trial hurdle as FDA continues review Late to the party: Europe on the verge of approving Roche and Celltrion antibodies for COVID Cortexyme picks a lower dose for nebulous Alzheimer's drug after phase 2/3 flop C2N's amyloid blood test for Alzheimer's risk matches up to PET scans in study Telehealth unicorn Thirty Madison goes brick-and-mortar with in-person hair restoration clinic Featured Story | By Ben Adams Reports are coming in that President Joe Biden is on the cusp of nominating former Obama pick Robert Califf M.D. as his new FDA commissioner. read more |
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Top Stories By Robert King A majority of surgeons warn in a new survey that nearly 10% in Medicare payment cuts could lead to longer patient wait times and delays in care. read more By Nick Paul Taylor AstraZeneca has completed a clearout of its midphase pipeline, dumping a clutch of cancer, diabetes and cardiovascular disease drugs it picked up in deals including its $1 billion takeover of Ardea Biosciences. read more By Andrea Park Though initially estimated to affect about 427,000 COVID-19 tests, the recall of Ellume’s rapid antigen at-home tests has since expanded to include more than quadruple that amount. read more By Angus Liu GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody drug sotrovimab already bears an FDA emergency use authorization as an infusion. Now, the pair hopes to win the same status for an intramuscular formulation. read more By Kevin Dunleavy Continuing a trend, especially among the largest firms in the pharmaceutical industry, Johnson & Johnson will form a new company to handle its consumer health business. The launch of the new publicly traded company is expected in 18 to 24 months. read more By Arlene Weintraub Cellectis is pressing ahead with several attempts at off-the-shelf CAR-Ts—and, now, it has preliminary data to back up one such effort that’s aimed at solid tumors. Its CAR-T targeting tumor associated antigen mesothelin showed activity in mice, the company reported. read more By Robert King Nursing homes have lost 221,000 jobs since the start of the pandemic even as other healthcare industries have been able to recover from job losses. read more By Conor Hale The company’s Aveir system aims to provide ventricular pacing on-demand—triggering an electrical pulse only when needed to get a slowing heart back on track, instead of a constant cadence. read more By Kevin Dunleavy Nearly a full year after the U.S. gave Regeneron’s antibody cocktail an emergency authorization, Europe is on the verge of approving the monoclonal antibody duo. The European Medicines Agency also recommended another antibody, Celltrion’s regdanvimab. read more By Annalee Armstrong Just over two weeks after boldly deciding to forge on with an Alzheimer’s drug despite a failed phase 2/3 clinical trial, Cortexyme now says it will use a lower dose in studies to come. read more By Conor Hale A study of C2N Diagnostics’ blood test showed it could help predict which people may be at an increased risk for Alzheimer’s disease based on the level of amyloid proteins found in the brain—a task that has traditionally requires PET scans, spinal taps or biopsies for cerebrospinal fluid. read more By Rebecca Torrence Digital health unicorn Thirty Madison has previously used virtual visits and medication delivery to serve customers across its brands. But early next year, the company plans to open its first in-person location—a hair transplant clinic in New York City, the first step in a long-term brick-and-mortar strategy. read more | 