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FDA: Drug Companies Routinely Hide The Reasons Their Drugs Are Rejected From Investors

Seven times between August 11, 2008, and June 27, 2013, the Food and Drug Administration declined to approve a new medicine, in part, because patients were more likely to die when taking the drug than in a control group. Yet only one of those companies told investors – and the public – about that concern. […]

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Pfizer’s Pristiq Flunks Phase III MDD Trial

Pfizer Reports Top Line Results from a Phase 3 Study Evaluating Desvenlafaxine Succinate Sustained-Release Formulation in Pediatric Patients with Major Depressive Disorder NEW YORK, Jun 11, 2015 (BUSINESS WIRE) — Pfizer Inc PFE, +0.44% announced the top line results from a Phase 3 study which evaluated the efficacy, safety, and tolerability of Pristiq® (desvenlafaxine succinate […]

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Watchdog accuses FDA of wrongly expanding Vanda sleep drug use

U.S. regulators have inappropriately expanded the approved use of Vanda Pharmaceuticals Inc’s sleep disorder drug Hetlioz beyond its original indication for use in blind people, the consumer watchdog Public Citizen said on Thursday. The U.S. Food and Drug Administration approved the drug in January 2014 to treat Non-24-hour sleep-wake disorder in blind patients. But that […]

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MSF urges India not to cave to pressure on affordable drugs

Charity Medecins Sans Frontieres appealed to India on Thursday not to give in to pressure from Europe, the United States and Japan to make it easier for big firms to get patents in the country, potentially blocking the production of cheap generics. MSF, also known as Doctors Without Borders, said changes proposed at negotiations for […]

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Spending On These 10 Drugs Could Cost Taxpayers $50 Billion – Is That Bad For Patients?

That’s a pretty provocative headline coming from an Avalere report sponsored by America’s Health Insurance Plans (AHIP), the national trade association that represents the health insurance industry.  At a time when many Americans are getting worried about rising healthcare costs and the impact of the Affordable Care Act (“Obamacare”) on their pocketbooks, such a headline […]

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Pfizer Report Shows Scientist Warned Execs About Zoloft Risks Last Year

A report from Pfizer Inc. (PFE) shows a scientist urged company officials change safety labels for the popular antidepressant Zoloft after a potential link between the drug and birth defects was shown, Bloomberg reported this morning. Last week during a trial in Pennsylvania where the plaintiff alleges Zoloft prescribe to her during her pregnancy was […]

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Celgene Shells Out $82.5 Million in Cash for Portfolio, Option to Buy Lycera

Ann Arbor, Mich.-based biopharma Lycera will license its RORgamma agonist to Celgene Corporation (CELG) as part of a $105-plus deal to create new cancer immunotherapies which also give Celgene the option to buy Lycera, the two companies announced Tuesday. Under the terms of the deal, Celgene will pay Lycera $82.5 million in cash up front, […]

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Giant Study Boosts Januvia, Merck’s $6 Billion Drug

Januvia, a widely used diabetes drug that generates $6 billion in annual sales for maker Merck, does not increase patients’ risk of being hospitalized for heart failure, a risk that did show up in clinical trials of competing drugs. “We’ve teased this data backwards and forwards and everything comes up looking like the drug does […]

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Mylan Launches First Bioequivalent Alternative to Combination Asthma Therapy Seretide Evohaler (Salmeterol Xinafoate/Fluticasone Propionate) Under the Brand Name Sirdupla™ in the UK

HERTFORDSHIRE, England, and PITTSBURGH, June 8, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced that it has launched the first bioequivalent alternative to GlaxoSmithKline’s Seretide® Evohaler® (salmeterol xinafoate/fluticasone propionate) under the brand name Sirdupla™ in the UK.[1] Sirdupla is a pressurized metered-dose inhaler (pMDI) and is indicated to help treat or prevent symptoms of asthma […]

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10 Drugs To Cost Government $50B Over Next Decade

An eye-popping bill for just a handful of specialty medications is in the pipeline for the federal government—and therefore, taxpayers—in the next 10 years, the health insurance industry’s lead trade group warned Monday. “We are witnessing a return to dramatic increases of year-to-year drug spending,” said Dan Durham, interim CEO of America’s Health Insurance Plans. […]

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