Lilly / Daiichi Sankyo - Effient: Clot Wars continue

Back stories here. And here.

Food and Drug Administration medical reviewers said the agency should approve Effient (prasugrel), a proposed anti-clotting drug being developed by Eli Lilly and Co. and Daiichi Sankyo Co., but should carry tough warnings about bleeding and cancer risks.

Reviews of Prasugrel by different FDA divisions were posted on the agency's Web site Friday.

The drug faces a review Tuesday by medical experts who serve on the agency's cardiovascular and renal drugs advisory committee. The panel is being asked to recommend if prasugrel should be approved for use in certain patients at risk for a heart attack and, if so, what warnings should be placed on the drug.

Last month, a European Medicines Agency committee issued a positive opinion recommending approval of prasugrel. That opinion will be forwarded to the European Commission which grants approval for drugs in the European Union. The commission usually follows that agency's advice.

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Lilly beat BMS to ImClone

ImClone has agreed to be acquired by Eli Lilly for about $6.1 billion, Reuters reports, citing sources familiar with the situation.

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Are AstraZeneca the "mystery bidder" for ImClone

You tell me.

Generic German Plavix - Ja!

A German court has allowed a generic version of the blockbuster anticlotting drug Plavix to be marketed there (starting immediately) by Ratiopharm and another generic-drug company called Yes.

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Platelet wars! Plavix vs Effient

The chief operating officer of Bristol-Myers Squibb said Eli Lilly's rival Effient blood clot preventer will be a "niche" product if approved and the TRITON study found it either harmed or offered no benefit to three types of patients.

"There are three important subgroups of patients that seem to derive either net harm or no clinical advantages" from Effient, Lamberto Andreotti told analysts in a conference call.

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Will BMS and AZ get the "saxagliptin blues"?

aka Onglyza!

The Food and Drug Administration is considering tougher standards for new and current diabetes drugs, raising concern in the pharmaceutical industry that the agency may ultimately raise the time and cost needed to approve of a wide array of new drugs.

The FDA is weighing whether to insist that new diabetes drugs have a positive impact on cardiovascular disease and life span, which are more difficult to measure than current benchmarks such as lower blood sugar.

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Plavix / Aspirin combo application pulled

European regulators have revealed that Sanofi-Aventis and Bristol-Myers Squibb have withdrawn a marketing authorisation application for a drug which combines the blockbuster Plavix with aspirin.

The European Medicines Agency said it had been formally notified by the firms’ decision to withdraw its application for DuoPlavin (clopidogrel/acetylsalicylic acid), which was expected to be used by patients already taking clopidogrel (Plavix) and acetylsalicylic acid (aspirin) for the prevention of atherothrombotic events in acute coronary syndrome. The application was submitted to the EMEA on May 30 and was under review by the agency's Committee for Medicinal Products for Human Use (CHMP).

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Dolan loses AmEx after "change of status"!

Peter Dolan, fired last week as chief executive of drugmaker BMS, has resigned from American Express's board of directors, the credit card and travel services company said.

In a Monday regulatory filing, New York-based American Express said Dolan resigned from its board on Sept. 15, "following his change of status" at BMS.

Oh dear, how sad, never mind!