USFDA

ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for AP32788, a tyrosine kinase inhibitor (TKI) designed as a targeted therapy for patients with non-small cell lung cancer (NSCLC) with specific mutations in EGFR or HER2. ARIAD anticipates initiation of its Phase 1/2 clinical trial of AP32788 in patients with NSCLC in the second quarter of 2016.

LivaNova PLC, announced it has been granted approval from the United States Food and Drug Administration (FDA) for its innovative stented aortic bioprosthesis CROWN PRT for the treatment of aortic valve disease.  This is the second valve to be approved in the U.S. this year and is expected to be launched in the coming months.  LivaNova’s Perceval valve, the sutureless biological valve on the market for aortic valve replacement procedures, was approved on January 8, 2016.

Proteostasis Therapeutics, Inc., announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PTI-428, an investigational oral treatment for cystic fibrosis (CF).

Dr. Reddy's Lab (DRL) has received tentative approval from the US health regulator for anti-biotic Zenavod indicated for the treatment of a type of chronic skin disease in adult patients.

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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.

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.