Big pharma’s last two weeks have included a phase 3 setback, a new FDA approval and a fresh round of 340B litigation. Here’s what to know:
- Amylyx Pharmaceuticals said its investigational drug avexitide reduced severe hypoglycemic events by 55% compared to placebo in a phase 3 trial for post-bariatric hypoglycemia, according to an Aug. 18 news release. Amylyx plans to submit a new drug application by the end of 2026.
- AstraZeneca discontinued a phase 3 trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer after an independent data monitoring committee determined the regimen was unlikely to improve survival compared with pembrolizumab plus chemotherapy, according to an Aug. 17 news release. Other phase 3 trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma and mesothelioma will continue as planned.
- AstraZeneca sued Illinois Attorney General Kwame Raoul on Aug. 14 over the state’s new 340B contract pharmacy law. AbbVie and Novartis filed similar suits against the law earlier in the month, arguing it unconstitutionally forces manufacturers to sell discounted drugs through an unlimited number of contract pharmacies.
- Eli Lilly filed six lawsuits against U.S. compounding pharmacies, medical spas and online sellers it accuses of illegally selling black-market versions of retatrutide, its investigational obesity drug still in phase 3 trials. The company said it has also referred more than 200 individuals and entities to regulators and law enforcement worldwide.
- Bristol Myers Squibb won accelerated FDA approval for Zenbexus (iberdomide), the first approved CELMoD therapy, in combination with daratumumab and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, according to an Aug. 13 news release.
- Prescription drug prices fell 3.1% over the 12 months ending in July — the steepest annual decline in more than six decades — while the index also dropped 0.8% from June to July.
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