Latest News in the pharma Industry

Policy & Regulation

FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

19 Dec 2016

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

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New Repatha dose delivery option receives positive CHMP opinion

New Repatha dose delivery option receives positive CHMP opinion

16 Dec 2016

The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.

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Merck's Idenix Pharmaceuticals awarded $2.54 billion for infringement of a hepatitis C drug patent

Merck's Idenix Pharmaceuticals awarded $2.54 billion for infringement of a hepatitis C drug patent

16 Dec 2016

In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent.

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FDA approves Synjardy XR tablets for adults with type 2 diabetes

FDA approves Synjardy XR tablets for adults with type 2 diabetes

13 Dec 2016

New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.

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Novartis' Lucentis received EU approval in new indication

Novartis' Lucentis received EU approval in new indication

10 Dec 2016

Lucentis the only treatment available for a wide range of CNV conditions.

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Mederi's Stretta Therapy for GERD approved in China

Mederi's Stretta Therapy for GERD approved in China

9 Dec 2016

Clinically proven and cost-effective solution for gastroesophageal reflux disease recently launched in China.

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Pfizer refutes the findings set out in the CMA decision

Pfizer refutes the findings set out in the CMA decision

8 Dec 2016

Pharma giant says it complied with established competition law.

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FDA approves Jardiance tablets to reduce the risk of cardiovascular death in adults with T2D

FDA approves Jardiance tablets to reduce the risk of cardiovascular death in adults with T2D

5 Dec 2016

The only oral T2D medicine to provide a life-saving cardiovascular benefit.

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GSK's Relvar Ellipta gains approval in Japan for COPD patients

GSK's Relvar Ellipta gains approval in Japan for COPD patients

3 Dec 2016

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FDA accepts BLA for avelumab for the treatment of metastatic MCC for Priority Review

FDA accepts BLA for avelumab for the treatment of metastatic MCC for Priority Review

29 Nov 2016

If approved by the FDA, avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

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European Commission approves BMS's Opdivo for Hodgkin's

European Commission approves BMS's Opdivo for Hodgkin's

24 Nov 2016

Opdivo is now the first and only PD-1 inhibitor approved for a hematologic malignancy in the European Union.

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NICE ‘yes’ to Imnovid in the fight against the biggest blood cancer killer in the UK

NICE ‘yes’ to Imnovid in the fight against the biggest blood cancer killer in the UK

23 Nov 2016

Pomalidomide available to people in England immediately via the Cancer Drugs Fund.

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