Sept. 17 Quick Takes: Another Tecfidera setback for Biogen; plus ChemoCentryx PDUFA date and Amytrx’s debut
Tecfidera patent ruling another setback for Biogen
The U.S. District Court for the District of Delaware concluded that another court’s prior ruling invalidating a patent for Tecfidera dimethyl fumarate from Biogen Inc. (NASDAQ:BIIB) does apply under the principles of collateral estoppel. The ruling removes uncertainty that generics companies can launch Tecfidera competitors, as Mylan N.V. (NASDAQ:MYL) has already done at risk. Wednesday’s ruling followed a June decision by the U.S. District Court for the Northern District of West Virginia (see “More Pressure on Biogen's Pipeline”).
July PDUFA date for ChemoCentryx vasculitis therapy
ChemoCentryx Inc. (NASDAQ:CCXI) said Thursday FDA has accepted the company’s NDA for avacopan, a C5a receptor inhibitor, to treat antineutrophil cytoplasmic antibody (ANCA) associated vasculitis. The PDUFA date is July 7, 2021...