Industry News

Allergan plc. , a leading global pharmaceutical company  announced that its Phase III ready investigational medication rapastinel (GLYX-13) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Major Depressive Disorder (MDD). This follows the Fast Track Designation for rapastinel granted by the FDA in 2014.

MabVax Therapeutics Holdings, Inc., announces receipt of notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with 89Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015.  MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.

Matinas BioPharma Holdings, Inc., announced that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is authorized to initiate a Phase 1 clinical study for investigational drug, MAT2501 (encochleated amikacin), for the treatment of  non-tuberculous mycobacterium (NTM) infections, its lead chronic indication.

ACADIA Pharmaceuticals Inc., a biopharmaceutical company announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in ACADIA’s New Drug Application (NDA) for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease.

Allergan plc  announced that it has entered into a global agreement with AstraZeneca to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam. Together, the two companies will evaluate the combination to treat serious infections caused by metallo βlactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae (CRE), for which there are currently very limited treatments, thus presenting a new treatment option for patients with MBL-producing pathogens. Under the terms of the agreement, Allergan will maintain commercialization rights in the U.S. and Canada and AstraZeneca will maintain commercialization rights in all other countries.

Dr. Reddy's Laboratories, announced  that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously.

The U.S. Food and Drug Administration  approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. Halaven is marketed by Eisai based in Woodcliff Lake, New Jersey.

The U.S. Agency for International Development (USAID) today announced three new awards to support the Government of India’s efforts to end tuberculosis (TB) in India.

AbbVie , in cooperation with Neurocrine Biosciences, Inc. announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo.