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BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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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.