Latest News in the pharma Industry

Policy & Regulation

Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection

Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection

2 Mar 2016

Certified quality of analytical services for developers of biologics and biosimilars .

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Amgen submits sBLA for Blincyto (blinatumomab)

Amgen submits sBLA for Blincyto (blinatumomab)

2 Mar 2016

Filing based on Phase II study showing Blincyto provides meaningful therapeutic benefits in difficult-to-treat type of pediatric acute lymphoblastic leukemia.

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Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of hemophilia B

Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of hemophilia B

2 Mar 2016

If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.

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True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD

True North Therapeutics receives Orphan Drug Designation in the EU for TNT009 for the treatment of autoimmune hemolytic anemia, including CAD

29 Feb 2016

Top-line Phase Ib data in patients with CAD expected in mid-2016.

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FDA approves new indication for Novartis drug Afinitor for progressive, nonfunctional GI and lung neuroendocrine tumours

FDA approves new indication for Novartis drug Afinitor for progressive, nonfunctional GI and lung neuroendocrine tumours

28 Feb 2016

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET.

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FDA approves Genentech’s Gazyva for certain people with previously treated follicular lymphoma

FDA approves Genentech’s Gazyva for certain people with previously treated follicular lymphoma

26 Feb 2016

This is the second FDA approval for Gazyva based on a positive Phase III study.

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FDA accepts and grants Priority Review for Avycaz sNDA

FDA accepts and grants Priority Review for Avycaz sNDA

25 Feb 2016

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated intra-abdominal infections , in combination with metronidazole.

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FDA accepts Sanofi NDA for once-daily fixed-ratio combination of insulin glargine and lixisenatide

FDA accepts Sanofi NDA for once-daily fixed-ratio combination of insulin glargine and lixisenatide

23 Feb 2016

FDA decision anticipated in August 2016.

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Mylan's ANDA for generic Advair Diskus accepted for filing by FDA

Mylan's ANDA for generic Advair Diskus accepted for filing by FDA

22 Feb 2016

FDA provides GDUFA goal date of 28 March 28 2017

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Pfizer receives expanded FDA approval for Ibrance in HR+, HER2- metastatic breast cancer

Pfizer receives expanded FDA approval for Ibrance in HR+, HER2- metastatic breast cancer

21 Feb 2016

First-in-class therapy now approved for use in a broader range of women.

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Novartis drug PKC412 receives Breakthrough Therapy designation from FDA for newly-diagnosed FLT3-mutated AML

Novartis drug PKC412 receives Breakthrough Therapy designation from FDA for newly-diagnosed FLT3-mutated AML

21 Feb 2016

PKC412 (midostaurin) significantly improved overall survival of adult patients eligible to receive standard induction and consolidation chemotherapy.

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Rx-360 summary of the FDA proposed rule for combination products

Rx-360 summary of the FDA proposed rule for combination products

19 Feb 2016

The proposed rule would harmonize the requirements for prescription and nonprescription products.

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