Latest News in the pharma Industry

Policy & Regulation

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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Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma

Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma

15 Mar 2017

Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin

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Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

14 Mar 2017

Dietary supplement products "misbranded" and unapproved new drugs being marketed with drug claims despite not being approved for any use.

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Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin

Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin

13 Mar 2017

Settlement provides Mylan with global licenses for its trastuzumab product.

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Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatment of myelodysplastic syndromes

Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatment of myelodysplastic syndromes

13 Mar 2017

BI 836858 was previously granted orphan drug designation for the treatment of patients with AML.

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