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The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk.
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
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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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Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
Alumis held its initial public offering in June last year, while Acelyrin debuted on the Nasdaq in mid-2023.
In a mid-stage study, the candidate itolizumab achieved 23.3% clinical remission rate at 12 weeks, numerically better than Humira’s 20% at the same time point.
According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far.
Bristol Myers Squibb clocked $10 million in sales for new schizophrenia drug Cobenfy in the fourth quarter of 2024, with the launch proceeding ahead of expectations.
The headcount reduction will save money that the company will use in developing mavorixafor, its CXCR4 antagonist that last year received FDA approval to treat WHIM syndrome, in the larger patient population with chronic neutropenia.
Bristol Myers Squibb will make even deeper cuts to its organization to enhance efficiencies as it faces the 2028 loss of exclusivity for its blockbuster drugs Eliquis and Opdivo.
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.