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Pharma News 7_5

Prasugrel review extended – Daiichi Sankyo Company, Limited, and Eli Lilly and Company said that the U.S. Food and Drug Administration (FDA) has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period…more

Heart trials for diabetes medicines? – The agency wants its Endocrinologic and Metabolic Drugs Advisory Committee to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large…more

Paxil and pregnancies – Much of the hoopla one reads about the controversial antidepressant concerns the risk of suicide and the extent to which the drugmaker disclosed – or did not disclose – meaningful clinical trial data…more

Doctors under the Influence?

Breathing easier at Merck and Schering? – Could it be? Are they getting a divorce over Vytorin? No, sorry to excite you. But the drugmakers are ending their respiratory joint venture and their eight-year effort to market a combination of their Claritin and Singulair medications, which are used to treat allergic rhinitis…more

Analyst takes up news space with BMS conjecture – The drugmaker looks increasingly attractive and a sale is a “distinct possibility,” according to Tim Anderson, a pharma analyst at Sanford Bernstein…more

Pharma’s sinking reputation – The latest Harris Interactive poll that examines American attitudes toward corporate America offers a sobering view of and for the pharmaceutical industry. Only 26 percent of Americans view the industry favorably…more

Can’t make this stuff up – A drug developed using nanotechnology and a fungus that contaminated a lab experiment may be broadly effective against a range of cancers, U.S. researchers reported on Sunday…more

Sweet home Alabama – A state court jury decided the two drugmakers defrauded Alabama in a long-running Medicaid drug pricing scheme and ordered them to pay more than $114 million in damages, the Associated Press reports…more

Pfizer rocking the CME funding world – In what may be a first, a drugmaker will still support continuing medical education courses at academic institutions, teaching hospitals and those supported by medical societies, but no longer directly support CME courses offered by for-profit medical-education and communication companies, Dow Jones reports…more

Xience (drug-eluting stent from Abbott) gets approval.

They do pass laws in D.C., after all – Earlier this year, the city became the first in the country to license sales reps, whose licenses can be revoked if their activities are deemed fraudulent. The bill was passed in hopes of enforcing good business practices on people who have undue influence over docs, and therefore patients…more

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