Ranbaxy will pay $500 million to settle issues with the U.S. Food and Drug Administration over manufacturing problems at multiple plants. The settlement finalized a long-running investigation by the FDA. When Ranbaxy’s generic version of Lipitor was approved on November 30, there was speculation it meant that Ranbaxy had reached an agreement with the agency to resolve issues related to falsifying records that resulted in the production and sale of AIDS drugs that failed to meet FDA standards. However, no mention of a settlement was made then. Now, the consent decree as well as the $500 million provision to resolve all potential civil and criminal liabilities confirms that a settlement has been reached.

AstraZeneca reported back-to-back setbacks on a pair of key drug development programs. After reporting that it would nix its ovarian cancer drug program for Olaparib after a mid-stage failure, AstraZeneca and Targacept reported that their partnered drug for depression, TC-5214, failed its second of four late-stage trials. Just as in the first late-stage study, TC-5214 did no better than a placebo at treating depression. AstraZeneca will, however, attempt to study Olaparib in other forms of cancers and still has two more late-stage trials to complete for TC-5214. Burrill & Company, publisher of The Burrill Report, is an investor in Targacept.

Merck has agreed to pay $24 million to settle civil charges that it knowingly submitted inflated prices to price-reporting services causing the state of Massachusetts to overpay pharmacists for a widely used asthma medication under the Medicaid program. The agreement, unveiled by the Attorney General of Massachusetts, resolves a 2003 lawsuit against 13 drug makers over inflated prices for medicines that were sold in pharmacies.

After completing a safety review of Sanofi’s heart drug, Multaq, the U.S. Food and Drug Administration concluded that the drug doubled the risk of serious cardiovascular events, including death, when used by patients with permanent hearth arrhythmias. The review comes after French regulators decided to no longer pay for the drug and the European Medicines Agency restricted its use to patients for whom previous and alternative treatments had failed. Despite the grim news, Sanofi did catch a break when the FDA didn’t pull the drug entirely from the market, and instead provided still more updates to the Multaq label.
The U.S. Food and Drug Administration joined Novartis in investigating the death of a multiple sclerosis patient who had taken Gilenya for the first time. The 59-year-old patient died within 24 hours of starting treatment. Though Gilenya has been associated with some serious potential side effects, including a slowed heart rate, the FDA said it could not draw any conclusive links between the drug and the death of the patient, who was also using two cardiovascular drugs, a beta-blocker and a calcium channel blocker. “At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed,” the agency said in a statement. “[FDA] recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label.”

Novartis halted the development of its high-blood pressure treatment Rasilez for long-term use due to unwanted side effects when added to standard therapy. Rasilez was launched in the United States in 2007 for the treatment of high-blood pressure but Novartis was seeking to expand the use of the drug, believing that it could protect key organs in patients who are at high risk of suffering heart or kidney failure, if taken over a long period of time. A committee overseeing the study, however, identified higher unwanted side effects when Rasilez was added to standard therapy. The data was enough to prompt Novartis to terminate the trial, effectively dashing its hopes of a blockbuster drug.

Sanofi’s oral multiple sclerosis experimental therapy, Aubagio, was found to be no more effective than Merck KGaA’s injectable multiple sclerosis treatment, Rebif, in a head-to-head study. The results may prove to be costly, even though Aubagio distinguishes itself from injectable MS treatments. “Aubugo has the advantage of being an oral treatment, but its potential will be limited by more efficacious drugs,” Bryan, Garnier & Co. analyst Eric le Berrigaud told Bloomberg. “If there weren’t other medicines like Gilenya, BG-12, and Lemtrada in the clinic, [Aubagio] would be a great product.”

Vivus’ shares fell after the company released data linking one of the key ingredients in its experimental diet drug Qnexa with oral cleft defects in the children of mothers who took the drug early in their pregnancies. The prevalence rate of .29 percent in the group of women who took the drug during their pregnancy was higher than the .16 percent rate in the group of women who took Qnexa prior to becoming pregnant.

Sunovion Pharmaceuticals will lay off an undisclosed number of sales representatives that are responsible for selling the company’s asthma drugs. The number of layoffs was earlier reported to be near 300, the Boston Business Journal reported.

Johnson & Johnson has requested that retailers return about 12 million bottles of Motrin over concerns the painkiller may not dissolve fast enough. Tests of the Motrin samples showed that some caplets don’t dissolve as expected when the drug is near its expiration date, J&J said in a statement on its website. The recall is not a consumer level recall, meaning consumers do not have to dispose of or return the product; they just may experience a delay in relief after taking the drug. The recall covers Motrin distributed in the United States, Puerto Rico, Fiji, Belize, the Bahamas, St. Lucia and Jamaica, according to the statement.