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Study finds numerous drug combinations sold in India lack regulatory approval

A person holds pharmaceutical tablets and capsules in this picture illustration taken in Ljubljana September 18, 2013. Reuters/Srdjan Zivulovic Almost two-thirds of the drug combinations widely sold in India to fight pain, depression, and psychotic conditions lack the necessary regulatory approvals, despite some of the pills being banned internationally, a study published on Tuesday shows. […]

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Orexigen says obesity drug safety trial terminated

Orexigen Therapeutics Inc and its partner Takeda Pharmaceutical Co said they were terminating a trial assessing the cardiovascular safety of obesity drug, Contrave. Orexigen Therapeutics shares were down 12.5 percent in after market trading after falling 13.6 percent in regular trading on the Nasdaq on Tuesday. The study was not being terminated due to the […]

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Orexigen says obesity drug safety trial terminated

A trial assessing the cardiovascular safety of obesity drug Contrave, made by Orexigen Therapeutics Inc and Takeda Pharmaceutical Co Ltd, was terminated on Tuesday due to unauthorized release of study data. A statement from Cleveland Clinic, which was conducting the trial, said the study was being halted as unauthorized release of trial data by Orexigen […]

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Number of Americans using $100,000 in medicines triples: Express Scripts

More than a half-million U.S. patients had medication costs in excess of $50,000 in 2014, an increase of 63 percent from the prior year, as doctors prescribed more expensive specialty drugs for diseases such as cancer and hepatitis C, according to an Express Scripts report released on Wednesday. Of the estimated 575,000 Americans who used […]

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U.S. says insurers must cover FDA-approved birth control methods

The U.S. government said health insurers must cover all FDA-approved methods of birth control without co-pays or charges to the patient, as it issued a paper on Monday looking to clarify coverage guidelines under the Affordable Care Act. Recent published reports found that some payers were ignoring federal requirements for covering birth control, a benefit […]

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Endo Pharmaceuticals Shells Out $130 Million for Nearly 70 Pipeline Programs From Aspen Pharmacare Holdings

DUBLIN — Endo International (ENDP) has continued its trend of expanding its portfolio through acquisitions, announcing a $130 million deal to acquire a large portfolio of anti-pain anti-infectives, cardiovascular and other therapeutics areas from Aspen Pharmacare Holdings, the company said this morning. The deal includes products that are currently on the market, as well as […]

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Horizon Pharma plc Announces Settlement of PENNSAID(R) 2% Patent Litigation With Perrigo Company plc

DUBLIN, IRELAND–(Marketwired – May 8, 2015) – Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that its affiliates have entered into a settlement and license agreement with Perrigo Company plc and its […]

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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 […]

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MarketResearch.com: 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, MarketResearch.com 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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Venezuela says probing drugmakers for improper use of hard currency

(Reuters) – Venezuela is investigating whether drug companies including Germany’s Merck KGaA and Bayer AG have improperly profited from subsidized foreign exchange amid growing medicine shortages, the country’s health minister said. Those firms have received a favorable exchange rate through Venezuela’s currency controls to produce or import price-controlled medication to treat chronic ailments such as […]

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EU watchdog disagrees with negative view on UniQure gene therapy

(Reuters) – European regulators do not agree with the negative view expressed by one adviser about the efficacy of UniQure’s drug Glybera, the Western world’s first gene therapy. The Dutch company said it had received a final assessment report from the European Medicines Agency’s Committee for Advanced Therapies (CAT) following doubts raised by the adviser, […]

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Emergency Physicians Are Not Likely To Prescribe Opioids To Discharged Patients

While some people visit primary care physicians when they’re in pain, others head to the emergency room. With emergency physicians wanting to provide pain relief to their patients, prescribing opioids to discharged patients may seem like the best option to some — but many physicians are refusing to jump the gun too soon. Published in the Annals of Emergency Medicine, a journal […]

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