News
By improving gait stability, Ionis’ zilganersen could be “potentially disease modifying,” according to analysts at William Blair.
FEATURED STORIES
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
From Wall Street to real estate to a “big, ugly” pharma building, Mayo Venture Partner Audrey Greenberg reflects on a career defined by taking a leap at just the right moment.
Job Trends
Arvinas, Inc. and Pfizer Inc. announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera estrogen receptor degrader, in combination with palbociclib.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
THE LATEST
While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.
During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
In December 2024, Teva also secured FDA approval for the other liraglutide brand Victoza, indicated for type 2 diabetes.
Health Secretary Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Sept. 4, following the ouster of CDC Director Susan Monarez and tapping of HHS Deputy Secretary Jim O’Neill as her interim replacement.
Nipocalimab, approved as Imaavy for generalized myasthenia gravis earlier this year, failed to show significantly added benefit when used with an anti-TNFα therapy in patients with rheumatoid arthritis.
In another blow to Prothena’s neurodegenerative disease portfolio, anti-amyloid candidate PRX012 has run into the same problem that larger peers Biogen and Eli Lilly have battled: high rates of swelling in the brain.
Sometimes, job interviews stand out for all the wrong reasons, including odd settings, off-topic topics and questionable decorum. BioSpace collected several stories that highlight biopharma professionals’ strangest experiences as they pursued employment.
Exelixis is looking at the possibility of relocating some of the eliminated Pennsylvania roles to its headquarters in Alameda, California, according to a company spokesperson.
The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.”
Novo Nordisk has brought on other cardiometabolic collaborators this year, including United Laboratories International and Deep Apple Therapeutics.