Latest News in the pharma Industry

Policy & Regulation

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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Alcon receives FDA approval for pre-loaded intraocular lens delivery system to treat patients undergoing cataract surgery

Alcon receives FDA approval for pre-loaded intraocular lens delivery system to treat patients undergoing cataract surgery

5 Oct 2015

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UK and India regulators agree deal for closer collaboration to improve public safety

UK and India regulators agree deal for closer collaboration to improve public safety

5 Oct 2015

MHRA signs Memorandum of Understanding with its counterpart body in India.

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FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

2 Oct 2015

Sandoz is seeking approval for all indications included in the reference product's label.

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FTC files amicus brief explaining that pharmaceutical “product hopping” can violate the antitrust laws

FTC files amicus brief explaining that pharmaceutical “product hopping” can violate the antitrust laws

2 Oct 2015

The FTC filed its amicus brief in a private antitrust action in which Mylan Phamraceuticals Inc. alleges that Warner Chilcott PLC/Mayne Pharma Group maintained a monopoly in the market for its antibiotic Doryx by suppressing generic competition through...

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