Pharma News

USFDA post warning letters to 14 companies for selling illegal cancer treatments

  • Posted on: 28 April 2017
  • By: Shalini.Sharma

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


NPPA revises ceiling prices of 4 scheduled formulations of Schedule-I under DPCO Amendment Order, 2016 and retail price of 1 formulation under DPCO, 2013

  • Posted on: 27 April 2017
  • By: Shalini.Sharma

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.


Government fix ceiling price of scheduled formulation under para 4 of DPCO, 2013

  • Posted on: 27 April 2017
  • By: Shalini.Sharma

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 Pharma get FDA Clearance of IND for GBR 310

  • Posted on: 26 April 2017
  • By: PharmaTutor News

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 receives USFDA approval for Olmesartan Medoxomil Tablets and Olmesartan Medoxomil

  • Posted on: 26 April 2017
  • By: PharmaTutor News

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 Scientists Discover Novel Therapeutic Mechanism of Inhibition of Formation of Toxic Beta Amyloid Oligomers

  • Posted on: 25 April 2017
  • By: PharmaTutor News

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.


Achillion Pharmaceuticals announced results from the ongoing phase 2 ‘604 Study’

  • Posted on: 25 April 2017
  • By: PharmaTutor News

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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