USFDA

Dr.  Reddy’s Laboratories Ltd. Receives FDA approval for  ZEMBRACE^TM      SymTouch^TM (sumatriptan succinate) Injection for the  acute  treatment of migraines in adults.

Neos Therapeutics, Inc., a pharmaceutical company with a late?stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older.

Biofrontera , the biopharmaceutical company focusing on sun-induced skin cancer, announced recent progress on the ongoing approval process for Ameluz® and BF-RhodoLED® in the USA. FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.

Aortica Corporation  announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study sponsored by Dr. Benjamin Starnes – Chief of Vascular Surgery at the University of Washington (UW).  The supplement names Aortica as the supplier of both a Fenestration Alignment Software and a patient-specific 3-D printed fenestration template.

Amgen  announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

Immunocore, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune disease,  announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead programme, IMCgp100, for the treatment of uveal melanoma. The Orphan Drug status qualifies Immunocore for a number of development incentives and will enable Immunocore to receive fast track registration for IMCgp100, its lead ImmTAC (Immune mobilising mTCR Against Cancer) therapeutic.

Merck , known as MSD outside the United States and Canada,  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Fate Therapeutics, Inc, a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for cancer and immune disorders, announced the U.S. Food and Drug Administration (FDA) has cleared the Company's investigational new drug (IND) application for ProTmune™, a programmed cellular immunotherapy consisting of donor-sourced mobilized peripheral blood cells which have been functionally modulated using two small molecules. The IND is now active and Fate Therapeutics plans to initiate a multi-center, randomized, controlled Phase 1/2 clinical trial in adult patients with hematologic malignancies undergoing mobilized peripheral blood (mPB) hematopoietic cell transplantation (HCT) in mid-2016.

Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery,  announced it has received FDA 510(k) clearance for NEUROCAP, an innovative device designed to reduce painful neuroma formation and thereby facilitate tissue repair and regeneration.

Athenex, Inc. announced  that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel. This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug.