Latest News in the pharma Industry

Policy & Regulation

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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FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

19 Dec 2016

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

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New Repatha dose delivery option receives positive CHMP opinion

New Repatha dose delivery option receives positive CHMP opinion

16 Dec 2016

The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.

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Merck's Idenix Pharmaceuticals awarded $2.54 billion for infringement of a hepatitis C drug patent

Merck's Idenix Pharmaceuticals awarded $2.54 billion for infringement of a hepatitis C drug patent

16 Dec 2016

In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent.

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FDA approves Synjardy XR tablets for adults with type 2 diabetes

FDA approves Synjardy XR tablets for adults with type 2 diabetes

13 Dec 2016

New once-a-day formulation indicated to improve blood sugar when used along with diet and exercise.

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