The U.S. Food and Drug Administration approved Octapharma USA’s Wilate for the treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.

Pfizer Inc. is investing $500 million to expand a manufacturing facility in Sanford, North Carolina, that plays a central role in the company’s efforts to become a major player in gene therapy.

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

Bayer plans to build a Cell Culture Technology Center in Berkeley, Calif., investing $150 million in the project. The center will focus on developing biologics, an area where Bayer lags behind the company’s competitors.

Bayer is looking into future options for the established drugs business, partly because of price pressure in China, the German company’s head of pharmaceuticals said.

Pfizer acquired a 15 percent stake in Vivet Therapeutics as well as an exclusive option to fully acquire the business, a deal that will give the New York-based pharma giant access to the French company’s experimental gene therapy for a rare genetic disorder.

The EU’s CHMP adopted a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.

The European Commission granted Marketing Authorization for Shire’s ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated], for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.

lnylam Pharmaceuticals Inc., the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced the initiation of the ATLAS Phase 3 clinical program for fitusiran.

Baxalta’s effort to align its marketing to customer behavior has led the company into unmapped territory for a pharmaceutical company – Instagram.