Latest News in the pharma Industry

Policy & Regulation

NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option

NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option

21 Jan 2016

NHS patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy.

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Lilly and Incyte submit NDA to FDA for oral once-daily baricitinib

Lilly and Incyte submit NDA to FDA for oral once-daily baricitinib

20 Jan 2016

Baricitinib is for the treatment of moderate-to-severe rheumatoid arthritis.

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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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