USFDA

The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software. Outside the US, the software is already extensively used and offered via MSmetrix.

Evoke Pharma, Inc. announced that it has completed a pre New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company's planned 505(b)(2) NDA for Gimoti.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.

Matinas BioPharma Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead drug candidate, MAT2203, as a Qualified Infectious Disease Product (QIDP) with Fast Track status for prophylactic treatment of invasive fungal infections due to immunosuppressive therapy.

MiMedx Group, Inc., the leading regenerative medicine company, announced its plans for the nationwide launch of AmnioFill, the first product in the MiMedx placental collagen matrix product family to be commercially launched.

Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.

Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%).

Genmab A/S announced  that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.

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