Latest News in the pharma Industry

Policy & Regulation

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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Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

11 Feb 2016

Sandoz's late-stage biosimilar pipeline gains momentum with sustained investment - five of 10 planned regulatory filings achieved.

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Shire partner, Shionogi, submits NDA in Japan for ADHD treatment for children

Shire partner, Shionogi, submits NDA in Japan for ADHD treatment for children

11 Feb 2016

With submission, Shire continues to strengthen its presence in Japan.

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Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

10 Feb 2016

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

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FDA approves expanded use of BMS’s Daklinza

FDA approves expanded use of BMS’s Daklinza

8 Feb 2016

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.

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Oasmia submits MAA to the EMA for its lead cancer product Apealea

Oasmia submits MAA to the EMA for its lead cancer product Apealea

8 Feb 2016

The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.

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