Industry News

- Read more about Novartis acquire Texas-based Encore Vision
Novartis has entered into a definitive agreement for the acquisition of Encore Vision, Inc., a privately-held company in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia. This acquisition would add a first-in-class disease modifying topical treatment for presbyopia to the Novartis ophthalmology pipeline, providing a potentially disruptive innovation to patients in a new therapeutic area of high unmet need and high prevalence. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.
- Read more about FDA accepts Vernalis’ CCP-08 NDA for full review
Vernalis plc and Tris Pharma, Inc. are pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the CCP-08 New Drug Application ("NDA") for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of 4 August 2017.
- Read more about Cipla receives final approval for generic Tricor® tablets
Cipla Ltd, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, has received final approval for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA).
- Read more about Sun Pharma to acquire branded oncology product Odomzo® (sonidegib) for global markets
Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies today announced its plans to acquire a branded oncology product, Odomzo, from Novartis. The agreement has been signed between subsidiaries of both the companies and will close following anti-trust clearance and further closing conditions. The agreement has been signed for an upfront payment of US$ 175 million and additional milestone payments.
- Read more about Tonix Pharmaceuticals’ announce U.S.FDA granted breakthrough therapy designation toTNX-102 SL
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).
- Read more about Pain Therapeutics Discuss regulatory path forward for REMOXY® ER with FDA
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.
- Read more about Novelion Therapeutics' subsidiary introduce JUXTAPID® (lomitapide) in Japan
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).
- Read more about Merck's anti-PD-1 therapy, Keytruda receives Japanese approval
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.

[adsense:336x280:8701650588]
- Read more about Recent charges of price collusion among generic drug manufacturers to have serious implications: ICRA
As a step-up to the ongoing probe by the anti-trust department of the US Department of Justice (DoJ), initiated in October 2014, on the sharp increases in prices of certain generic drugs in the US and the possibility of cartelisation among the drug makers, 20 US States filed a lawsuit on December 15, 2016 against six pharmaceutical companies – Aurobindo Pharmaceuticals Limited, Citron Pharma LLC, Heritage Pharmaceuticals Inc., Mayne Pharma, Mylan NV and Teva Pharmaceuticals. The lawsuit alleges these companies for conspiring the prices of two generic drugs –Doxycycline Hyclate (an anti-biotic) and Glyburide (an anti-diabetic drug).
- Read more about Loxo Oncology provide update for Larotrectinib (LOXO-101) and its Pipeline drug candidates
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.