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 […]
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 […]
HHS OIG will review FDA’s approval of Biogen’s aducanumab
The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally. […]
Introducing ‘BYOP’ clinical trials
BYOD — “bring your own device” — became a common term in tech circles a decade ago. Now with primary care doctors playing a growing role in clinical trials, the provider of decentralized clinical research software Curebase (San Francisco) aims to popularize the concept of “BYOP” — “bring your own physician.” That is, the company is […]
Rani Therapeutics prices $73M IPO for robotic drug-delivery pill tech
Rani Therapeutics Holdings (NSDQ:RANI), developer of a robotic drug-delivery pill system, generated $73.3 million in its underwritten initial public offering (IPO) of Class A common stock. The San Jose, Calif.–based company’s IPO of 6.7 million shares priced at $11 a share, generating gross proceeds of $73.3 million. The company initially targeted an IPO worth approximately […]
Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call
With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call. While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during […]
Walmart teams up with Novo Nordisk to launch private-brand analog insulin
Walmart (NYSE:WMT) is launching what it describes as the first private label analog insulin. The company estimates the insulin products will save customers between 58% and 70% of the cost of branded insulin. Novo Nordisk (NYSE:NVO) will manufacture the analog insulin, which is a type of lab-grown insulin genetically engineered to optimize glucose control. The […]
Athira Pharma’s stock falls 39% after placing its CEO on leave
The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave. The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020. Washington State University has launched an […]
Senator Manchin asks Biden to oust Woodcock over Aduhelm row
The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB). The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand […]