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J&J diabetes drug shows heart benefit in large safety study

Johnson & Johnson’s type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting.

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Drug reduces dyskinesia, ‘off’ times in Parkinson’s patients

An experimental extended-release version of the drug amantadine can reduce the duration of the involuntary dancing-like movements seen in people whose long-term use of levodopa has kept their Parkinson’s disease under control.

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Supreme Court speeds biosimilars to market

The U.S. Supreme Court cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines.

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Proxy firm ISS advises vote against Mylan board, backing investor group

Influential proxy firm ISS advised voting against generic drugmaker Mylan NV’s incumbent board of directors, saying it should be held responsible for reputational damage over drug-pricing issues and the chairman’s pay package.

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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

Gilead Sciences Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.

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FDA rejects Coherus’ biosimilar for Amgen’s Neulasta

Coherus BioSciences Inc. said the U.S. FDA denied the approval of its biosimilar for Amgen Inc.’s blockbuster treatment Neulasta, which fights infections in cancer patients.

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SoCal’s Regulus Sinks After AstraZeneca Bails on Lead NASH Drug

Shares of Regulus were down more than 23 percent after pharma giant AstraZeneca terminated its involvement with the company’s clinical development program for the treatment of non-alcoholic steatohepatitis (NASH).

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Sanofi-Regeneron’s Praluent cuts cholesterol in Odyssey trials

France’s Sanofi and partner Regeneron Pharmaceuticals said their anti-cholesterol drug Praluent recorded positive results in its first dedicated studies involving patients with diabetes and high cholesterol.

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Investigational SGLT-2 Inhibitor Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies

Merck in partnership with Pfizer Inc. announced that two Phase 3 studies of ertugliflozin met their primary endpoints.

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Purohit Navigation expands staffing capabilities with key hires

Purohit Navigation – a full-service, independent, healthcare communications and advertising agency – announced that the company has expanded its already seasoned staff to serve a growing client base.

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