Latest News in the pharma Industry

Policy & Regulation

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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Tesaro announces FDA approval of Zejula for women with recurrent ovarian cancer

Tesaro announces FDA approval of Zejula for women with recurrent ovarian cancer

29 Mar 2017

US commercial launch planned for late April.

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Regeneron and Sanofi announce FDA approval of Dupixent

Regeneron and Sanofi announce FDA approval of Dupixent

28 Mar 2017

First targeted biologic therapy for adults with moderate-to-severe atopic dermatitis.

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Pfizer receives positive CHMP opinion for Trumenba for prevention of meningococcal group B disease

Pfizer receives positive CHMP opinion for Trumenba for prevention of meningococcal group B disease

27 Mar 2017

Trumenba has been studied in a global clinical development program evaluating the vaccine in adolescents and adults.

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BMS receives positive CHMP opinion recommending Opdivo for head and neck cancer

BMS receives positive CHMP opinion recommending Opdivo for head and neck cancer

26 Mar 2017

Opdivo already approved by the EC for six indications in four distinct tumour types.

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