A quiet end to a short week. We apologize for the interruption in service, but we were attending a meeting that required a bit of travel. Now, however, we have returned to lasso a few items that have come to our attention in our absence. Meanwhile, we hope you enjoy the weekend. Our own to-do list includes shuttling about with one or more of the short people. See you shortly…

As threatened, Lilly and its Japanese partner, Daiichi Sankyo, have asked the FDA to approve the prasugrel blood clot buster. The drugmakers submitted data from several clinical trials, including one that compared the drug to Plavix. The overall results demonstrated that for every 1,000 patients treated with prasugrel as compared with Plavix, there were 22 fewer patients with heart attacks, but, major bleeding occurred in 2.2 percent of those on prasugrel versus 1.7 percent of those on Plavix. If it reaches the marketplace, by the way, the drug will be renamed Effient.

Two developments regarding Merck and lawsuits: Lawyers who rep 2,600 people are challenging a key provision of a proposed $4.85 billion settlement that requires them to advise all or none of their clients to accept the deal, the Associated Press reports. They want a federal judge in New Orleans to rule that portions of the settlement can’t be enforced in all states because it preventsl lawyers from giving clients “independent professional advice.” Plaintiffs lawyers who negotiated the settlement say they expect the challenge will be withdrawn, as a similar one filed last month was yanked. Separately, a federal judge in New York denied motions to certify classes of Fosamax patients, who wanted Merck to set up a program to monitor them for an ailment involving jaw bone decay, Reuters writes. More than 360 federal product liability cases have been filed against Merck by people who claim to have taken the osteoporosis drug.

Dan Vasella, the Novartis ceo, has high cholesterol, but takes Pfizer’s Lipitor instead of his own Lescol. He tried Lescol twice, but it didn’t agree with him. “I have side effects on our own lipid-lowering drug,” he told the WSJ Health Blog. “I don’t have them on Lipitor, so I take Lipitor. It’s funny but it’s true.” Vasella used this disclosure to make the point that people can respond differently to drugs of the same type. That is a good point. We’re not surprised to hear that Dan has high cholesterol, though. During an off-the-record dinner with we attended with him at the Plaza Hotel in New York some time ago, we recall that he ate rather rich food.

A subsidiary of an international surgical device manufacturer is under federal investigation for allegedly paying kickbacks to doctors to use its equipment, according to court documents and company disclosures, The Boston Globe reports. The federal case against Blackstone Medical got a boost yesterday when an Arkansas neurosurgeon pleaded guilty to soliciting and accepting kickbacks from a salesman who worked for Blackstone’s parent company, Orthofix International, as well as three other companies. Additional charges were dismissed in exchange for Dr. Patrick Chan’s agreement to cooperate in the government’s investigation into separate allegations that Blackstone and other companies defrauded the Medicaid and Medicare programs by paying illegal incentives to other doctors. Those allegations are contained in a whistle-blower’s lawsuit.

Looking to understand a few basics about how pharma goes about defending itself in court? Many of you already know this, of course, but the Drug and Device Law blog has worked up a quick primer, which focuses on preemption (a topic we have covered regularly), Daubert hearings concerning the validity of scientific evidence, and the learned intermediary principle which, essentially, puts the prescribing doc in the middle of it all.

And for those who thought 2007 was a dismal one for drug approvals - you are correct. The In Vivo blog makes it all very clear in this nicely done summary of a year that wasn’t for many drugmakers.