June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China
A first from Ultragenyx in a rare disease
FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be approved for the rare disease. It is also approved to treat X-linked hypophosphatemia.
Court win for Mylan in Tecfidera IP case
While investors had hoped a February IP decision had removed an overhang for Tecfidera dimethyl fumarate from Biogen Inc. (NASDAQ:BIIB), the multiple sclerosis drug is once again at risk of facing generic competition. On Thursday, the U.S. District Court for the Northern District of West Virginia invalidated a patent for Tecfidera for lack of written description, opening the door for Mylan N.V. (NASDAQ:MYL) to launch its dimethyl fumarate product upon FDA approval. Biogen’s only other Orange Book-listed patent for the drug expires on June 20. Biogen shares fell $21.16 to $260.30 on Thursday (see “Tecfidera IP Win”)...