Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News, which cites a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within some governing […]
COVID-19
Overcoming vaccine delivery device design’s top challenges
Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world. Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for […]
Amazon makes moves for a major medical diagnostics play
Amazon (NASDAQ: AMZN) wants to hire key employees to expand its medical diagnostics operations on a global scale, which very well could grow beyond COVID-19 testing. Senior-level job postings offer a glimpse of the notoriously secretive and ambitious tech company’s global aspirations for medical diagnostics. Just this week, Amazon put a call out for a […]
Pfizer seeks FDA blessing for COVID-19 vaccine booster
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate that […]
Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies
Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime […]
Abbott disputes New York Times story about destroyed COVID-19 test inventory
Abbott (NYSE:ABT) has responded to a New York Times article reporting the disposal of COVID-19 test inventory at a Maine factory. The New York Times article on Aug. 20 stated that, as COVID-19 cases dwindled in the U.S. in June and July, workers at Abbott’s Westbrook, Maine, facility that produced its BinaxNow rapid COVID-19 tests were […]
FDA approves Pfizer-BioNTech COVID-19 vaccine
The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. In addition, the vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years […]
How Delta could change the COVID-19 landscape
Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco. But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely […]
Novavax stock surges after striking EU COVID-19 vaccine deal
Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine. The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial […]
Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet
Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Get the full story at our sister site, Drug Delivery Business […]
MedTech 100 roundup: Industry climbs with earnings season in full swing
Better-than-expected quarterly earnings are providing a further boost to medtech industry stocks. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 30) at 118.86 points. Two weeks ago aside — when the index shot up to 145.88 points and quickly tumbled down — this mark […]