BioSpace News Archive

Allecra Therapeutics announced the submission of a New Drug Application to the U.S. Food and Drug Administration for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections.

Foresee Pharmaceuticals, announces that it has successfully completed an underwritten public offering of 17,500,000 shares of its common stock to the public at a price of NT$75 per share.

Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted the company’s Biologics License Application for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency.

Xentria Inc. and Meitheal Pharmaceuticals, Inc. announced an exclusive multi-year licensing agreement to commercialize its lead candidate, and novel biologic, XTMAB-16 for pulmonary sarcoidosis in North America.

Boston Scientific Corporation announced the election of Dr. Jessica L. Mega and Susan E. Morano to its board of directors, each effective immediately.

Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535.

PharmaTher Holdings Ltd. is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) to support expedited review of its priority ANDA.