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Italian drugmaker Chiesi Farmaceutici plans to extend its rare disease portfolio in a $1.48 billion buyout of UK-based Amryt Pharma, gaining Amryt’s Filsuvez, a naturally derived product just approved in Europe for treating the rare inherited skin disorder epidermolysis bullosa. Read More
The U.S. Court of Appeals for the First Circuit said that it will not revive several hundred lawsuits accusing GSK of failing to warn female patients that its anti-nausea therapy Zofran (ondansetron) could induce birth defects. Read More
Otsuka and developmental partner Lundbeck have snagged FDA priority review of their supplemental new drug application (sNDA) for Rexulti (brexpiprazole) as a treatment for agitation in people with Alzheimer’s disease. Read More
In a move that could affect many drugmakers and their patient assistance programs, the U.S. Supreme Court has refused to take up Pfizer’s appeal that it should be able to offer a copay assistance plan to patients to help them pay for the company’s expensive heart medication. Read More
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee struggled to find definitive answers when it met Monday to consider dosing and labeling for Regeneron Pharmaceuticals’ aflibercept as a treatment for retinopathy of prematurity (ROP), a leading cause of childhood blindness. Read More
Eli Lilly and South San Francisco, Calif.-headquartered TRexBio have inked a multi-year research collaboration and licensing deal potentially worth up to $1.1 billion to develop therapies for immune-mediated diseases. Read More
AstraZeneca announced a plan to purchase Waltham, Mass.-based CinCor Pharma in a deal worth up to $1.8 billion as it looks to expand its pipeline of heart and kidney drugs with CinCor’s hypertension candidate baxdrostat. Read More
On the heels of nabbing accelerated approval of its Alzheimer’s therapy Leqembi (lecanemab), Eisai has filed for full approval of the drug in patients with mild cognitive impairment (MCI) or mild dementia and confirmed presence of amyloid beta plaque in the brain. Read More