Latest News in the pharma Industry

Policy & Regulation

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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Impax receives FDA approval for generic version of Adderall XR capsules, CII

Impax receives FDA approval for generic version of Adderall XR capsules, CII

17 Feb 2016

Company due to supply its ANDA product during the second quarter of 2016.

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UK court rules against Lilly in Alimta vitamin regimen patent lawsuit

UK court rules against Lilly in Alimta vitamin regimen patent lawsuit

17 Feb 2016

Lilly plans to seek permission to appeal the ruling.

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Merck receives Complete Response Letter from FDA for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin)

Merck receives Complete Response Letter from FDA for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin)

16 Feb 2016

The company is reviewing the letter and will determine next steps.

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