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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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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.
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).
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 announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha (evolocumab). The new automated mini doser (AMD) with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.
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.
AMTZ (Andhra MedTech Zone) aims to make India a self-sufficient and in fact an exporter of good quality and cost-effective medical technology.
The objective of the Seminar was to familiarize the Industry on this opportunity which exists in fulfilling this gap which is likely to only widen as the healthcare services reach out to semi-urban and rural areas. The seminar also threw up opportunities for foreign collaborations for technology transfers and financing for setting up units.
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