Latest News in the pharma Industry

Policy & Regulation

Cardinal Health reaches $20 million settlement with West Virginia

Cardinal Health reaches $20 million settlement with West Virginia

9 Jan 2017

Company collaborating with all participants in the pharma supply chain to tackle to the epidemic of prescription drug abuse.

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FDA accepts for filing sNDA for Liletta 52 mg

FDA accepts for filing sNDA for Liletta 52 mg

4 Jan 2017

Application seeks to extend duration of use up to 4 years for Liletta.

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BioNet receives Thai FDA approval of the world's only available recombinant monovalent acellular Pertussis vaccine

BioNet receives Thai FDA approval of the world's only available recombinant monovalent acellular Pertussis vaccine

29 Dec 2016

BioNet's vaccine is the first recombinant monovalent Pertussis vaccine in the world to receive a MAA for booster indication in adolescents and adults.

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Positive Phase III results of Genentech’s investigational medicine Ocrevus

Positive Phase III results of Genentech’s investigational medicine Ocrevus

28 Dec 2016

Ocrevus is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies.

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FDA approves Shire's Adynovate

FDA approves Shire's Adynovate

28 Dec 2016

New FDA-approved indications for Adynovate provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule.

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FDA places clinical hold on several Phase I trials of Vadastuximab Talirine

FDA places clinical hold on several Phase I trials of Vadastuximab Talirine

28 Dec 2016

Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events.

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FDA approves first drug for spinal muscular atrophy

FDA approves first drug for spinal muscular atrophy

26 Dec 2016

Spinraza improved motor function in SMA patients.

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Cardinal Health agrees to pay $44 million to the Department of Justice

Cardinal Health agrees to pay $44 million to the Department of Justice

26 Dec 2016

Payment resolves the outstanding civil penalty portion of the company's 2012 administrative settlement with this US DEA.

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New pill available on the NHS for patients suffering with psoriatic arthritis

New pill available on the NHS for patients suffering with psoriatic arthritis

22 Dec 2016

Oral Otezla receives positive NICE recommendation for adults with psoriatic arthritis.

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Metformin products, including Glucophage approved for type 2 diabetes patients with moderate renal impairment in Europe

Metformin products, including Glucophage approved for type 2 diabetes patients with moderate renal impairment in Europe

22 Dec 2016

European Commission decision confirms Metformin for treatment in type 2 diabetes patients with moderate renal impairment, which will lead to extended treatment access.

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FDA extends review of application for Ocrevus

FDA extends review of application for Ocrevus

21 Dec 2016

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

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FDA grants accelerated approval to Rubraca for the treatment of advanced ovarian cancer

FDA grants accelerated approval to Rubraca for the treatment of advanced ovarian cancer

20 Dec 2016

First and only PARP inhibitor in the US indicated t.o treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations.

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