Industry News

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.

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Loxo Oncology, Inc.,a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers,  announced a comprehensive program update for larotrectinib (LOXO-101), a selective inhibitor of tropomyosin receptor kinase (TRK), and its pipeline drug candidates, LOXO-292 and LOXO-195.

Clovis Oncology, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca™ (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Amgen and UCB announced that an application seeking marketing approval of romosozumab for the treatment of osteoporosis for those at high risk of fracture has been submitted for review to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Amgen and UCB are co-developing romosozumab worldwide, with development in Japan being led by Amgen Astellas BioPharma (AABP) K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

Amedica Corporation, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company's porous silicon nitride from a large-animal model demonstrated bone healing into the material just four weeks after implantation. "We anticipate these preliminary findings will be confirmed with additional retrieval data in the near future.

68^th Indian Pharmaceutical Congress (IPC) is organised and started at city of happening, Visakhapatnam under the premises of Andhra University. More than 9000 delegates and students from various part of India participated in this event. This event is organised in Andhra University for three days, 16^th to 18^th December 2016. The main theme of the event is Quality pharmaceuticals & patients welfare.