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FDA declines expanded approval for Bristol-Myers’ Opdivo drug

Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient […]

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Mixed drinks with diet beverages may boost breath alcohol levels

People who mix alcohol and diet drinks end up with more alcohol on their breath, according to a new study. People who drank vodka mixed with diet soda had higher alcohol concentrations on their breath than those who drank the same amount of vodka mixed with regular soda, researchers write in Drug and Alcohol Dependence. […]

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Exclusive: Lazard works with Sanofi on $12.7 billion animal health unit deal – sources

Investment bank Lazard is working with Sanofi’s management to prepare a sale or listing of its Merial animal health unit, aiming to land the leading advisory job for the deal, which could value the business at up 12 billion euros ($12.7 billion), sources familiar with the matter said. Lazard is expected to win the role […]

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EU approves Roche’s Cotellic in combo therapy against skin cancer

The European Union gave its green light to Roche’s Cotellic for use in combination with the drug Zelboraf against advanced melanoma, the company said on Wednesday.   Roche is counting on Cotellic to help it revive flagging sales of five-year-old Zelboraf, which dropped 25 percent during the first nine months of 2015. It has been […]

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Pfizer’s Lyrica shows no relief from post-traumatic nerve pain

Pfizer Inc said its blockbuster pain drug, Lyrica, had failed to show benefit in patients suffering from a type of post-traumatic nerve pain, in a late-stage study. The drug did not lead to pain reduction in patients compared with a placebo, the company said on Wednesday. Currently, there is no approved treatment in the United […]

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Why Price Gouging May Come to an End

(And a way to save some drug companies from themselves) November 25, 2015 By Karl Thiel for BioSpace.com   Price gouging in the pharmaceutical industry has been much in the news lately. There was, of course, the recent case of Turing Pharma and its 5,400 percent increase on the price on Daraprim, a decades-old drug. […]

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Shkreli’s Turing Pharma Rolls Out a 50% Price Cut for Daraprim

New York and Zug, Switzerland-based Turing Pharmaceuticals LLC announced yesterday a 50 percent cut in its prices for toxoplasmosis drug Daraprim.   Turing and its controversial chief executive officer Martin Shkreli became the focus of a national discussion of drug pricing in August after it acquired Daraprim from IMPAX Laboratories, Inc. (IPKL) for $55 million. […]

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Research raises questions over ADHD drug effects

Researchers voiced concern on Wednesday about poor quality studies on the popular ADHD treatment Ritalin, saying evidence of some benefits, but also of sleep problems and appetite loss, suggests the drug should be prescribed with caution. Ritalin is sold by Swiss pharmaceutical firm Novartis NOVN.VX, known generically as methylphenidate and also sold under the brand […]

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FDA panel says BioMarin DMD drug data not persuasive enough

A panel of outside advisers to the U.S. Food and Drug Administration indicated that efficacy data from BioMarin Pharmaceutical Inc on its experimental drug for treating a muscle wastage disorder was not persuasive enough to warrant approval. The FDA panel did not officially vote on an approval of the drug, but 15 out of 17 […]

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Ad agency legend Al Nickel passes away

Medical advertising veteran Al Nickel passed away unexpectedly on Saturday at the age of 72 years. Mr. Nickel was a visionary and principal member of New York-based healthcare communications agency LLNS (Lyons, Lavey, Nickel, Swift). Mr Nickel is a member of the Medical Advertising Hall of Fame. He was inducted into the MAHF as part […]

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