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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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Read our takes on the biggest stories happening in the industry.
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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Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.
Skye Bioscience’s nimacimab fell short of investor and company expectations, but showed encouraging weight-loss results when combined with Wegovy, according to analysts at William Blair.
Amgen will offer its lipid-lowering drug Repatha directly to patients for $239 per month, representing a nearly 60% reduction from the current wholesale acquisition cost of $527.70.
A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big Pharma companies, while smaller biotechs are left to hope “the situation doesn’t get worse.”
The inaugural 40 Under 40 cohort includes CEOs, leaders who have founded or co-founded their company and executives from a range of disciplines. Winners’ accomplishments include shaping drug development, achieving key FDA milestones and launching a new field of study.
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.
The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.
AstraZeneca has invested heavily in AI, primarily through collaborations, including an up to $5.3 billion partnership with China’s CSPC Pharmaceutical in June.
This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.