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  •  Portola Pharmaceuticals Inc.  announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Betrixaban, an FDA Fast Track-designated investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant.

  • Oasmia Pharmaceutical, a company develops a new generation of drugs within human and veterinary oncology, and Karo Pharma have entered into an agreement under which Oasmia to acquire Karo Pharma's cancer project KB9520, which has shown promising results in pre-clinical models for a number of different types of cancer.

  • Abeona Therapeutics Inc. Announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ABO-102, a single intravenous injection of AAV gene therapy for subjects with MPS IIIA (Sanfilippo syndrome type A), a rare autosomal recessive disease affecting every cell and organ in the body causing neurocognitive decline, speech loss, loss of mobility, and premature death in children.

  • GSK submit sBLA to US FDA approval for shingles vaccine, Shingrix

    GlaxoSmithKline plc has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix, to the United States Food and Drug Administration (FDA), seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over.

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  • Mersana Therapeutics, Inc., a biotechnology company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its proprietary Fleximer® platform technology,  announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate XMT-1522.The compound is Mersana’s first pipeline product, and defines a new class of HER2-targeted therapies.

  • Bristol Meyer Squibb Companyannounced  that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.

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