December 2016

Tonix Pharmaceuticals Holding Corp. Announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).

Pain Therapeutics, Inc. announced it plans to meet with the U.S. Food and Drug Administration (FDA) in person on Monday, February 13, 2017 to discuss the regulatory path forward for REMOXY ER.  The Company will provide details of this FDA meeting after receipt of final meeting minutes.

Novelion Therapeutics  announced that subsidiary Aegerion Pharmaceuticals completed the first commercial shipment of JUXTAPID® (lomitapide) to a patient in Japan. In September 2016, JUXTAPID was approved by Japan's Ministry of Health, Labor & Welfare (MHLW) for patients with homozygous familial hypercholesterolemia (HoFH).

Merck, known as MSD outside the United States and Canada, announced that Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, has been approved in Japan for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first- and second-line treatment settings at a fixed dose of 200 mg every three weeks. MSD will manufacture and market Keytruda in Japan and will promote it with Taiho Pharmaceutical Co., Ltd.

Government is aware of the sale and advertisement of Ayurvedic medicines through TV channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and Rules framed thereunder. Presently, there are no regulatory provisions for pre-censorship on advertisements. Action is taken whenever violation of Advertisement Code is brought to the notice of the Ministry of Information and Broadcasting or the advertisement is found to be in contravention of the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.