Latest News in the pharma Industry

Policy & Regulation

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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FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment

FDA approves Basaglar (insulin glargine injection), a long-acting insulin treatment

17 Dec 2015

Basaglar is the first FDA-approved follow-on insulin glargine treatment.

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A Practical Guide to Writing Risk Management Plans

A Practical Guide to Writing Risk Management Plans

17 Dec 2015

Research and Markets has announced the addition of the "A Practical Guide to Writing Risk Management Plans (RMPS) (London, UK — 25 January 2016)" conference to their offering.

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NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

NICE ‘no’ for Opdivo, could deny some lung cancer patients one of the most significant advances in almost 20 years

15 Dec 2015

The draft decision specifically affects adult patients with locally advanced or metastatic squamous non-small cell lung whose disease has progressed after prior chemotherapy.

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Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

Rx-360 summary of PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE-009-12)

10 Dec 2015

The Guide covers GMP principles and active substances used as starting materials.

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