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AbbVie buys special review voucher for $350 million

AbbVie Inc has bought a priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs. United Therapeutics received a rare pediatric disease priority review voucher in March after its drug, Unituxin, was approved by the U.S. Food and Drug Administration to […]

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Fitch: Even as FDA Approvals Slow, Cancer Treatments Progress in Pharma R&D Pipeline

NEW YORK–(BUSINESS WIRE)–Despite a slight drop in the number of FDA drug approvals during first half 2015 (1H15), treatments for cancer remain an important component of pharmaceutical companies’ R&D pipelines, according to a new Fitch Ratings report. One-third of all drugs approved by the FDA this year were cancer treatments, and positive early data on […]

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Corbus Pharmaceuticals’ Investigational Drug Resunab Granted Fast Track Status by the U.S. FDA for the Treatment of Systemic Sclerosis

NORWOOD, MA–(Marketwired – Aug 19, 2015) – Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has designated as a Fast Track development program the investigation of Resunab™ for […]

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Intarcia Diabetes Implant Beats Merck & Co.’s $6 Billion Drug in Head-to-Head Study

Boston-based Intarcia Therapeutics, Inc., announced yesterday positive results from its Phase III Freedom-2 clinical trial comparing its late-stage ITCA 650 to Merck & Co. (MRK)’s Januvia for Type 2 diabetes.   The real news here is that ITCA 650 is a new type of diabetes treatment. It is a GLP-1 receptor agonist that utilizes a […]

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Intarcia’s Diabetes Treatment Clears Key Test

Closely held Intarcia Therapeutics Inc. said its implantable drug-delivery pump proved superior to Merck MRK -0.42 % & Co.’s top-selling drug Januvia in helping diabetes patients control blood sugar in a head-to-head clinical trial. The matchstick-size pump, called ITCA 650, is loaded with a year’s supply of the widely used diabetes drug exenatide and implanted […]

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U.S. FDA approves ‘female Viagra’ with strong warning

The first drug to treat low sexual desire in women won approval from U.S. health regulators on Tuesday, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.   The U.S. Food and Drug Administration said the pink pill, to be sold under the brand name […]

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E-Cigarettes Can Help Smokers Quit, Review Says

Electronic cigarettes are less harmful than smoking traditional cigarettes and can be effective tools to help smokers quit, according to a review published Wednesday by Public Health England, a government agency. The health agency is one of the first governmental organizations to endorse e-cigarettes. The devices, which heat liquid nicotine into a vapor, have been […]

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Sprout’s Libido Pill Won’t Come Close To Viagra’s Impact

The FDA has approved a controversial drug designed to enhance a woman’s sexual drive. Addyi (generic name: flibanserin), from Sprout Pharmaceuticals, acts in the brain to enhance a woman’s libido. By taking one pill a day for a month, clinical trials showed that women on Addyi on average increased their number of satisfying sexual events […]

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Amgen Reaches $71 Million Settlement With States

Amgen Inc. reached a $71 million settlement with 48 states related to allegations that the biotechnology company made unsubstantiated marketing claims about blockbuster drugs Aranesp and Enbrel, according to several state attorneys general. In a statement on Tuesday, Amgen said the settlement with the states resolves some of the same issues addressed in Amgen’s December […]

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FDA Approves First Drug to Boost Women’s Libido

The Food and Drug Administration approved on Tuesday the first pill designed to boost sexual desire in women, but studies show some serious side effects, including drowsiness, fainting and nausea. The little pink pill, often dubbed “Viagra for women,” in clinical studies had a modest effect in boosting women’s interest in sex. But there are […]

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