Pharma News

Alder BioPharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced the presentation of positive data from its Phase 2b clinical trial evaluating eptinezumab (formerly ALD403) for the prevention of migraine.

The US Food and Drug Administration (FDA) has posted warning letters to 14 US companies that illegally sell more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without the approval of the FDA, most often on websites and social media

The Maharashtra Food and Drug Administration (FDA) has warned two Fortis hospitals in the city of strict action for allegedly reusing disposable angio medical devices and overcharging patients for them.

Drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has revised ceiling prices of 4 scheduled formulations of Scheduled-I under Drug (Price Control) Amendment Order, 2016 and retail price of one formulation under DPCO, 2013.The scheduled formulations are Clotrimazole cream 1%, Ceftriaxone Powder for Injection 1gm, Erythropoietin Injection 2000 IU/ml and Erythropoietin Injection 10000 IU/ml and Monocef-SB 125 mg Injection.

The Department of Pharmaceuticals (DoP) directive to the NPPA comes following complaints from several manufacturers that the NPPA is adopting a practice that even when some brands/generic versions of a medicine of a company have less than 1% market share, the market share of all such versions of that medicine of that company is clubbed together.

Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to XOLAIR® (omalizumab) in healthy adult volunteers between 18 – 65 years of age.

Alembic Pharmaceuticals Limited announced that the Company has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Olmesartan Medoxomil Tablets, 5 mg, 20mg and 40mg and Olmesartan Medoxomil with Hydrochlorothiazide Tablets 20/12.5mg, 40/12.5mg and 40/25mg.

Alzheon, Inc. announced publication of a newly elucidated molecular mechanism of action for tramiprosate, the active agent in the company’s lead clinical drug candidate, ALZ-801. The company’s Phase 3-ready candidate ALZ-801 is an optimized prodrug of tramiprosate, with a substantially improved pharmacokinetic and safety profile compared to tramiprosate.

The global hypertrophic cardiomyopathy therapeutics market to grow at a CAGR of 1.80% during the period 2017-2021.

Achillion Pharmaceuticals, Inc.announced the presentation of updated results from the ongoing phase 2 ‘604 Study’ being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen). These results were presented as an oral presentation during the European Association for the Study of the Liver (EASL) 2017 International Liver Congress in Amsterdam. These results demonstrate that the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally.

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