Neurocrine Bioscience and Acadia Pharmaceuticals posted positive top-line results from their respective Phase III trials on major neurological diseases.
The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
The U.S. Food and Drug Administration approved Seattle Genetics’ Tukysa (tucatinib) in combination with chemotherapy agents trastuzumab and capecitabine for adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body.
Vivek Ramaswamy’s Roivant Sciences has launched another “vant” company, this time in China, in a partnership with Hong Kong-based Sinovant Sciences.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
Pfizer Inc. announced that the supplemental New Drug Application for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis, has been accepted for filing by the U.S. Food and Drug Administration.