Latest News in the pharma Industry

Policy & Regulation

Regeneron and Sanofi receive FDA approval of a new once-monthly dosing option for Praluent Injection

Regeneron and Sanofi receive FDA approval of a new once-monthly dosing option for Praluent Injection

26 Apr 2017

Monthly dosing schedule now approved in both US and EU.

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Recipharm delivers first serialised batch to Saudi Arabia

Recipharm delivers first serialised batch to Saudi Arabia

23 Apr 2017

Company has invested €300,000 into the project, which is part of a wider €40 million investment into new serialisation technology and processes to comply with the European Falsified Medicines Directive.

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Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

23 Apr 2017

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

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FDA approves Genentech’s Lucentis for diabetic retinopathy

FDA approves Genentech’s Lucentis for diabetic retinopathy

18 Apr 2017

First and only medicine FDA-approved to treat all forms of diabetic retinopathy.

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FDA issues complete response letter for baricitinib

FDA issues complete response letter for baricitinib

16 Apr 2017

Additional clinical data are needed to determine the most appropriate doses.

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FDA approves new indications for Harvoni and Sovaldi

FDA approves new indications for Harvoni and Sovaldi

9 Apr 2017

First HCV direct-acting antivirals approved for use in adolescents.

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Merck receives CRL from the FDA for TECOS study with sitagliptin

Merck receives CRL from the FDA for TECOS study with sitagliptin

7 Apr 2017

CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.

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Hikma enters into settlement agreement with Jazz for sodium oxybate

Hikma enters into settlement agreement with Jazz for sodium oxybate

6 Apr 2017

Agreement terms are "favourable for both parties".

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Amgen submits applications in the US and Europe to expand current indication for Xgeva

Amgen submits applications in the US and Europe to expand current indication for Xgeva

4 Apr 2017

Applications include data from the largest international trial conducted in multiple myeloma.

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FDA now happy with Alkem's API facility

FDA now happy with Alkem's API facility

4 Apr 2017

Company's CAPA addresses the three Form 483 observations.

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Novartis drug combination Tafinlar + Mekinist receives EU approval for BRAF V600-positive advanced NSCLC

Novartis drug combination Tafinlar + Mekinist receives EU approval for BRAF V600-positive advanced NSCLC

3 Apr 2017

New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC.

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FDA approves Genentech’s Ocrevus for relapsing and primary progressive forms of MS

FDA approves Genentech’s Ocrevus for relapsing and primary progressive forms of MS

29 Mar 2017

An important new treatment option for people with relapsing forms of multiple sclerosis demonstrating superior efficacy on the three major markers of disease activity compared with Rebif.

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