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Prescription Fish Oil Maker Hires Top Lawyer To Sue FDA On First Amendment Grounds

Amarin Pharmaceuticals, which was rebuffed by the Food and Drug Administration in its effort to market its fish oil pill Vascepa to treat high triglycerides, is suing the agency, saying its First Amendment rights are being violated. To make its case, the small drugmaker has hired one of the nation’s top free speech lawyers, Floyd […]

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WHO adds hepatitis C drugs to essential list, urges lower prices

The World Health Organization has added new curative treatments for hepatitis C to its essential medicines list, but the U.N. agency said prices needed to fall to make them accessible to patients in poorer countries. The treatment of hepatitis C, which affects about 150 million people globally and kills around half a million each year, […]

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Novartis says lung cancer drug Zykadia gains EU approval

Swiss drugmaker Novartis said European health regulators have approved a drug for advanced lung cancer that is intended to treat patients with a specific genetic mutation. Zykadia, or ceritinib, is from a new class of medicines known as ALK inhibitors. It was approved in April 2014 in the United States. It is designed for use […]

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FDA staff say Vertex CF combo works, unclear how

Vertex Pharmaceuticals Inc’s combination of an experimental compound and an approved drug significantly improved lung function in cystic fibrosis patients with the most common genetic mutation underlying the disease, FDA staff said. The U.S. Food and Drug Administration staff reviewers, however, were not sure whether Vertex’s already approved therapy, Kalydeco, had a positive effect alone. […]

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It Costs $10K More To Treat People With Diabetes, Insurers Say

It now costs $10,000 or more per person annually to treat someone with diabetes than someone who doesn’t have the chronic disease, according to a new analysis of large insurance company claims data. The Health Care Cost Institute, a Washington-based group backed by some of the nation’s largest insurance companies including UnitedHealth Group (UNH), Humana […]

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EU patent office revokes Celgene Revlimid patent; appeal planned

(Reuters) – Celgene Corp on Thursday said the European Patent Office revoked a key patent on the company’s flagship multiple myeloma drug Revlimid, a move that could shave a year or two from the medicine’s exclusivity in Europe. The so-called polymorph patent in question would have kept cheaper versions of Revlimid off the European market […]

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Antiplatelet Drug Ticagrelor More Effective Than Clopidogrel for Ad Hoc PCI Patients

SAN DIEGO, May 7, 2015 /PRNewswire/ — Antiplatelet drug ticagrelor (Brilinta®) works faster and is more effective in blocking platelet activity in low-­risk patients with acute coronary syndrome (ACS) than clopidogrel, according to a new study presented today as a late-­breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San […]

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Novartis AG’s ‘biosimilar’ drug sale blocked by U.S. appeals court

(Reuters) – A U.S. appeals court has blocked the sale of Novartis AG’s recently approved “biosimilar” form of Neupogen, Amgen Inc’s blockbuster drug used to prevent infections in cancer patients. A lower court judge rejected Amgen’s request for an injunction. The U.S. Court of Appeals for the Federal Circuit ruled on Tuesday, however, that the […]

Read More » Asthma Therapeutics Market to Reach $21.7 Billion by 2020, Says New GBI Research Report

WASHINGTON and NEW YORK and LONDON, May 7, 2015 /PRNewswire/ — As a leading provider of market research reports and solutions, is pleased to highlight a recent report by GBI Research, forecasting the asthma therapeutics market to hit $21.7 billion by 2020, a CAGR 2.4% over $18.4 billion in 2013. To view this report by […]

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J&J to consult ethicists on requests for experimental drugs

(Reuters) – Johnson & Johnson will become the first pharmaceutical company to formally seek advice from outside medical ethicists on “compassionate use” requests, in which desperate patients ask drugmakers to let them take an experimental medication, the company announced on Thursday. The ethicists’ recommendations will be advisory, with J&J making the decision. But the drugmaker […]

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