Latest News in the pharma Industry

Policy & Regulation

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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JHL Biotech receives approval From European authorities to begin biosimilar clinical trial

JHL Biotech receives approval From European authorities to begin biosimilar clinical trial

15 Feb 2016

First biotech company in Greater China region to receive European approval.

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CMA fines pharma companies £45 million

CMA fines pharma companies £45 million

12 Feb 2016

The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine.

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