Latest News in the pharma Industry

Research & Development

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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Parkinson’s disease market set to hit $3.2 billion by 2021 as search for cure continues

Parkinson’s disease market set to hit $3.2 billion by 2021 as search for cure continues

28 Feb 2016

GBI Research report says that despite steady market growth, various unmet needs remain and a cure is yet to be found.

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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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Cobra Biologics and Centre for Process Innovation collaborate to advance development of regenerative medicines

Cobra Biologics and Centre for Process Innovation collaborate to advance development of regenerative medicines

25 Feb 2016

Cobra and CPI will develop in depth scientific and technical understanding to allow a scalable and flexible manufacturing process to be developed to produce, purify and characterise a range of AAV vectors.

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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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