Latest News in the pharma Industry

Policy & Regulation

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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Sanofi NDA for lixisenatide accepted for review by FDA

Sanofi NDA for lixisenatide accepted for review by FDA

30 Sep 2015

First New Drug Application for a GLP-1 receptor agonist to include CV outcomes data.

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Lilly and Sanofi reach settlement agreement in US insulin glargine litigation

Lilly and Sanofi reach settlement agreement in US insulin glargine litigation

28 Sep 2015

Pending final FDA approval, Basaglar can be launched in the US beginning on 15 December 2016.

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Novo Nordisk receives US FDA approval for Tresiba and Ryzodeg 70/30

Novo Nordisk receives US FDA approval for Tresiba and Ryzodeg 70/30

28 Sep 2015

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Allergan launches generic version of Invega

Allergan launches generic version of Invega

25 Sep 2015

Allergan is the first company to receive FDA approval for and launch a generic version of Janssen's Invega.

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