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Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.
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While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
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Merck, known as MSD outside of the United States and Canada, announced that the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its key secondary endpoint of overall survival, for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
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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.
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Viracta’s closure comes on the heels of its delisting from Nasdaq last month and multiple rounds of layoffs last year.
Despite the discontinuations, CEO Pascal Soriot said AstraZeneca’s December 2020 acquisition of Alexion was a “fantastic” deal for the pharma.
Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
Most employers are expecting to hire this year, according to BioSpace data and Recruitment Manager Greg Clouse, who noted that companies are looking to do more than just replace people lost to turnover.
Wegovy sales increased by more than 100% over 2024. But that wasn’t enough to satiate analysts who want to know why Novo Nordisk can’t access more patients, particularly in the U.S.
Valerio only has cash to last three months, according to the DNA decoy specialist. The news comes less than six months after the company acquired Emglev Therapeutics to advance antibodies for autoimmune and inflammatory conditions, as well as cancers.
BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.
Despite significant dips in its vaccines sales, the British pharma narrowly beat consensus estimates for Q4 2024 and raised 2031 sales projections to just over $50 billion.
Amgen outperformed expectations in the fourth quarter of 2024, but revealed an FDA hold on early-stage obesity asset AMG 513 and the discontinuation of other programs.