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As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered.
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too.
Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional clinical trials of its GLP-1 drugs in addiction beyond a Phase II trial testing semaglutide and two other drugs with alcohol use as a secondary endpoint.
Imfinzi is one of AstraZeneca’s key growth drivers for 2025, with potential approvals in stomach and bladder cancers. The PD-L1 blocker brought in over $4.7 billion in sales last year.
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”
Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression.
A new Pitchbook report found $4.3 billion in funding to women-fronted biotech companies across 121 deals. The increase comes as sociopolitical headwinds slam into initiatives to support women and minorities.
Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision to declare the Wegovy shortage over. Eli Lilly did the same in a parallel case over Zepbound’s removal from the FDA shortage list and this week a judge denied the compounders’ injunction.
Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals.
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
While hiring activity has not yet picked up, it should do so soon, according to BioSpace Recruitment Manager Greg Clouse. Meanwhile, another year-over-year decrease in layoffs means less competition for jobs.
The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions.
Novo Nordisk’s NovoCare will now provide uninsured or underinsured patients access to Wegovy for just $499 per month—less than half of its list price.
At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma.
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.