The U.S. Food and Drug Administration accepted Novartis’ Biologics License Application and granted Priority Review for the company’s investigational sickle cell medicine crizanlizumab (SEG101).

Global Blood Therapeutics reported new data from the company’s Phase III HOPE trial of voxelotor in sickle cell disease (SCD).

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.

Myovant Sciences’ combination therapy met the main goal of a late-stage study testing the treatment in women with uterine fibroids.

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.

Astellas Pharma’s blood cancer drug Xospata continues to show impressive results in the acute myeloid leukemia setting.

A European Medicines Agency panel recommended a conditional marketing approval for a gene therapy from Bluebird Bio Inc. as a genetic blood disorder treatment, setting the stage for the U.S. biotech to win the company’s first regulatory nod.

Agios Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

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.