Latest News in the pharma Industry

Policy & Regulation

Mylan launches generic Felbatol tablets

Mylan launches generic Felbatol tablets

19 Jan 2016

Recommended for monotherapy or adjunctive therapy in the treatment of partial seizures.

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Benepali, the first etanercept biosimilar referencing Enbrel, approved in the EU

Benepali, the first etanercept biosimilar referencing Enbrel, approved in the EU

17 Jan 2016

Biogen will manufacture and commercialize Benepali in the EU.

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FDA grants Priority Review for venetoclax NDA

FDA grants Priority Review for venetoclax NDA

12 Jan 2016

Venetoclax, an investigational medicine, is a potential new way of treating the most common adult leukemia.

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Epigenomics receives FDA notification about status of pending approval decision for Epi proColon

Epigenomics receives FDA notification about status of pending approval decision for Epi proColon

8 Jan 2016

Final approval of the company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.

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Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA

Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA

8 Jan 2016

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

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Teikoku Pharma USA, Inc. announces FDA approval of docetaxel injection

Teikoku Pharma USA, Inc. announces FDA approval of docetaxel injection

30 Dec 2015

First non-alcohol formulation approved in the US.

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Actelion receices FDA approval of Uptravi  for the treatment of pulmonary arterial hypertension

Actelion receices FDA approval of Uptravi for the treatment of pulmonary arterial hypertension

30 Dec 2015

Uptravi will be made available to patients in the US in early January 2016.

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FDA warns of potential contamination of drug shipments from explosions in Tianjin City‏

FDA warns of potential contamination of drug shipments from explosions in Tianjin City‏

26 Dec 2015

The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd.

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Sun Pharma receives Warning Letter for Halol facility

Sun Pharma receives Warning Letter for Halol facility

22 Dec 2015

Company makes significant investments in automation and training to enhance its Quality Systems

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Boehringer Ingelheim's third generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation for treatment of patients with NSCLC

Boehringer Ingelheim's third generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation for treatment of patients with NSCLC

22 Dec 2015

FDA designation reinforces potential for BI 1482694 to become a new treatment option for patients with EGFR mutation-positive lung cancer with a T790M mutation.

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Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

21 Dec 2015

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master F...

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FDA Draft Guidance: Safety Assessment for IND Safety Reporting

FDA Draft Guidance: Safety Assessment for IND Safety Reporting

18 Dec 2015

The FDA has published draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators u...

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