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FDA
With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns.
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Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
FDA
BioSpace looks back at 2025 and where the FDA is going in 2026.
During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
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Pressure from the FTC and Pfizer is building around Novo Nordisk’s bid to snatch obesity biotech Metsera. The antitrust watchdog has spotted issues with the structure of Novo’s bid, while its New York-based rival has put more money on the table.
While investment has slowed in radiopharmaceuticals, analysts predict increased interest to come as Novartis shows just how successful radiopharmaceuticals can be.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
The Basel area is home to over 800 life sciences companies, including Novartis and Roche, according to nonprofit Basel Area Business & Innovation. The nonprofit’s CEO and a BeOne Medicines executive discuss the location’s evolution, advantages and future.
Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort?
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
Investors got to hear Novo Nordisk’s side of the Metsera bidding war drama for the first time on Wednesday, as the company reported third-quarter earnings. A rough quarter underscored the stakes for the Danish pharma.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to the progressive loss of control over movement.
Arena launched with $500 million in early 2024 to fund basic biological research, from which it planned to spin out dedicated companies to focus on drug development.