Latest News in the pharma Industry

Policy & Regulation

GSK’s Nucala (mepolizumab) receives approval from FDA

GSK’s Nucala (mepolizumab) receives approval from FDA

6 Nov 2015

First anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype.

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FDA requests further data for approval of Epigenomics' blood based colorectal cancer screening test

FDA requests further data for approval of Epigenomics' blood based colorectal cancer screening test

4 Nov 2015

Epigenomics adjusts 2015 outlook after FDA response letter.

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Rx-360 Summary of WHO Guidance on Good Manufacturing Practices - Inspection Report

Rx-360 Summary of WHO Guidance on Good Manufacturing Practices - Inspection Report

4 Nov 2015

Describes general principles and a recommended format for inspection reports for use by organizations performing pharmaceutical inspections.

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Regeneron’s Eylea Injection for the treatment of visual impairment secondary to myopic CNV gains EU approval

Regeneron’s Eylea Injection for the treatment of visual impairment secondary to myopic CNV gains EU approval

1 Nov 2015

Eyela already approved in the EU for neovasular (wet) age-related macular degeneration.

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FDA approves new dual combination bronchodilator Utibron Neohaler and stand-alone monotherapy Seebri Neohaler for patients with COPD

FDA approves new dual combination bronchodilator Utibron Neohaler and stand-alone monotherapy Seebri Neohaler for patients with COPD

30 Oct 2015

Utibron Neohaler (formerly QVA149;indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to place...

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Novartis receives positive CHMP opinion for the first IL-17A inhibitor Cosentyx to treat ankylosing spondylitis and psoriatic arthritis

Novartis receives positive CHMP opinion for the first IL-17A inhibitor Cosentyx to treat ankylosing spondylitis and psoriatic arthritis

23 Oct 2015

Cosentyx demonstrated rapid onset of action and long-term sustainability in patients with and without prior treatment using anti-tumour-necrosis-factor (anti-TNF) therapy.

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Impax receives FDA approval for generic version of Intuniv (guanfacine)

Impax receives FDA approval for generic version of Intuniv (guanfacine)

22 Oct 2015

Third generic product approved since the resolution of the warning letter at the Hayward facility.

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Shire provides update on next steps for lifitegrast in light of FDA CRL

Shire provides update on next steps for lifitegrast in light of FDA CRL

20 Oct 2015

Company plans to refile lifitegrast submission in the first quarter of 2016.

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Shire receives FDA complete response letter for lifitegrast NDA and plans to respond with OPUS-3 trial

Shire receives FDA complete response letter for lifitegrast NDA and plans to respond with OPUS-3 trial

19 Oct 2015

Topline results from OPUS-3 Trial expected before year-end.

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NICE approves new treatments for hepatitis C

NICE approves new treatments for hepatitis C

16 Oct 2015

NICE recommends Daklinza (daclatasvir) for use in some patients with the most difficult-to-treat type of chronic hepatitis C.

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FDA grants Priority Review for Daklinza (daclatasvir) sNDAs

FDA grants Priority Review for Daklinza (daclatasvir) sNDAs

6 Oct 2015

Three applications are under review for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1.

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Impax receives FDA approval for generic version of Diabeta (glyburide) tablets

Impax receives FDA approval for generic version of Diabeta (glyburide) tablets

5 Oct 2015

The company is preparing for commercialization of this product through Impax's generic division.

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