Latest News in the pharma Industry

Research & Development

Novo Nordisk successfully completes fifth Phase IIIa trial with semaglutide in people with type 2 diabetes

Novo Nordisk successfully completes fifth Phase IIIa trial with semaglutide in people with type 2 diabetes

24 Feb 2016

The trial successfully achieved its objective.

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Merck's investigational once-daily formulation of Isentress meets primary and secondary endpoints in pivotal Phase III study

Merck's investigational once-daily formulation of Isentress meets primary and secondary endpoints in pivotal Phase III study

24 Feb 2016

Results to be presented at future medical meeting, and regulatory submissions planned for 2016

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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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Vaginal ring provides partial protection from HIV in large multinational trial

Vaginal ring provides partial protection from HIV in large multinational trial

23 Feb 2016

NIH-funded study finds protective effect strongest in women over age 25.

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Amgen and UCB announce positive top-line results from Phase III study of romosozumab

Amgen and UCB announce positive top-line results from Phase III study of romosozumab

22 Feb 2016

Results from the FRAME study showed that women receiving subcutaneous injection of romosozumab monthly experienced a 73% reduction in the relative risk of a vertebral fracture through 12 months compared to those receiving placebo.

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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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Aptuit and Icagen agree to strategic alliance

Aptuit and Icagen agree to strategic alliance

22 Feb 2016

Alliance to provide drug discovery customers access to industry leading ion channel and transporter technologies.

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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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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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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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Juniper and Crystec sign agreement for next-generation medicines

Juniper and Crystec sign agreement for next-generation medicines

15 Feb 2016

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