Pfizer (PFE) said it was halting a trial of its experimental drug tanezumab to treat chronic low back pain and diabetic peripheral neuropathy at the request of the U.S. Food and Drug Administration. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain, the pharmaceutical company said. The FDA's request follows reports of adverse events in osteoarthritis patients taking tanezumab, and the agency's concerns regarding the potential for such events in other patient populations in which the compound is being studied. Pfizer said it will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab.
A U.S. Food and Drug Administration panel is advising the agency to revoke Roche's (OTCQX:RHHBY) right to market Avastin as a treatment for metastatic breast cancer after additional trial data convinced it that the biologic's risks might outweigh its benefits. The recommendation could put a $1 billion dent in Avastin's global sales some reports say, slicing as much as a sixth off Roche's $6 billion take from the drug in 2009 and opening up fears that European regulators may also revisit their approval of the drug's use in treating advanced breast cancer.
GlaxoSmithKline (GSK) said it is suspending enrollment of new patients in a post-marketing trial of Avandia at the request of the U.S. Food and Drug Administration pending the agency’s review of an advisory committee panel earlier this month that recommended imposing greater restrictions on the drug because of concerns over an elevated risk heart attack among people who use the drug. Patients already enrolled in the trial may continue to use the drug.
An independent data monitoring committee reviewing a late-stage clinical trial of Novartis Pharma (NVS) and its license partner Nordic Bioscience’s oral calcitonin incorporating Emisphere Technologies drug delivery technology to treat osteoarthritis of the knee is not showing the drug to be effective. The committee said an analysis of one-year data from the two year study show the drug is safe, but that there is no reason to continue the study for efficacy. The committee said the final decision whether to continue the study known as 2302 rests with the Sponsor. A parallel two-year late-stage study known as 2301 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee is still in progress. In December 2009, the data monitoring committee conducted a futility analysis of one-year data for all patients enrolled in this two-year study, including assessments of safety and efficacy parameters, and recommended continuing with such a study. The sponsor currently intends to continue the clinical program of oral calcitonin in osteoarthritis, including both the 2301 and the 2302 study.
Theratechnologies (OTC:THTCF) said that the U.S. Food and Drug Administration notified the company that its review of an application to market tesamorelin, an experimental drug to treat excess abdominal fat in HIV-infected patients with lipodystrophy, will take until the fourth quarter of 2010. The agency had been expected to act on the Montreal-based company’s application by the end of July. Theratechnologies stock fell nearly 20 percent on the news.
GlobeImmune laid off 25 percent of its 60-person staff, according to a report from the Daily Camera. CEO Timothy Rodell said "There will be no discontinuation in any projects. We just didn't need the level of resources we have." GlobeImmune is developing an experimental immunotherapy drug for the treatment of Hepatitis C.