Latest News in the pharma Industry

Research & Development

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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Capsugel and Pulmatrix collaborate to develop and manufacture novel inhaled therapeutics

Capsugel and Pulmatrix collaborate to develop and manufacture novel inhaled therapeutics

16 Feb 2016

Capsugel will combine its spray drying process development, scale-up expertise and commercial manufacturing capabilities with Pulmatrix’s iSPERSE (inhaled small particles easily respirable and emitted) technology.

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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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Incyte decides to discontinue JANUS studies of ruxolitinib plus capecitabine

Incyte decides to discontinue JANUS studies of ruxolitinib plus capecitabine

15 Feb 2016

The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.

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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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Newly published head-to-head data show Stiolto Respimat improved lung function across range of measures

Newly published head-to-head data show Stiolto Respimat improved lung function across range of measures

10 Feb 2016

Stiolto Respimat was compared with a European formulation of a combination of a long-acting beta agonist, salmeterol, and an inhaled corticosteroid, fluticasone propionate.

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