Latest News in the pharma Industry

Policy & Regulation

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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FDA approves Parkinson's disease drug

FDA approves Parkinson's disease drug

24 Mar 2017

First NCE approved for PD patients with motor fluctuations in the US in more than a decade .

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Mylan receives tentative approval for TLE400 under PEPFAR

Mylan receives tentative approval for "TLE400" under PEPFAR

21 Mar 2017

TLE400 is a fixed-combination containing Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg.

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FDA approves Novartis' Kisqali as first-line treatment for HR+/HER2- metastatic breast cancer

FDA approves Novartis' Kisqali as first-line treatment for HR+/HER2- metastatic breast cancer

16 Mar 2017

Kisqali plus letrozole showed treatment benefit across all patient subgroups regardless of disease burden or tumour location.

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Shire receives European approval for label extension of Cinryze

Shire receives European approval for label extension of Cinryze

16 Mar 2017

Cinryze is the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics.

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