Did the odds just get worse for Arena’s new weight drug?

After the FDA panel vote against Vivus's obesity drug Qnexa, analysts tracking the wave of new weight drugs headed to the agency have been hyper-sensitive about anything that could highlight concerns about the safety of the experimental treatments. So when the agency scheduled an in-depth review of Abbott's Meridia right ahead of Arena's (ARNA) lorcaserin--just as it tackled Avandia risks right ahead of the Qnexa session--it didn't take long for fresh fright to take hold. "The Meridia...

Orexigen weight-loss drug shows positive results in study

Results from COR-I, one of the Phase III trials supporting the NDA for Orexigen Therapeutics' (NASDAQ: OREX) weight-loss drug Contrave, show that patients taking the drug were two to three times more likely to lose at least 5 or 10 percent of their body weight compared with those taking placebo. The study results have been published online in the journal Lancet.   Treatment with Contrave also resulted in significant improvements versus...

Expert panel not convinced by Vivus’ Qnexa

GAITHERSBURG, MD -- Expressing the need for more information--especially about teratogenicity--an FDA expert panel has recommended against approval of Vivus' (NASDAQ: VVUS) obesity drug Qnexa. The vote was six in favor and ten against, with many of the no voters citing the need for more safety data. During the meeting, several of patients shared their experiences with Qnexa after taking the drug during clinical trials. They asked the committee to approve the drug, pointing to the...

Vivus’ Qnexa takes center stage during panel review

GAITHERSBURG, MD -- After two long days of helping review Avandia, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee today is taking a look at Vivus' (NASDAQ: VVUS) application for Qnexa (phentermine/topiramate CR). We won't know until the afternoon how the panel will vote, but during its presentation, Vivus highlighted the current medical need for an obesity treatment, as roughly 33.8 percent of the U.S. adult population is obese. Ahead of the meeting, TheStreet's Adam...

Vivus shares rally after FDA staffers detail Qnexa concerns

With an expert panel review looming in two days, FDA staffers outlined a series of potential risks associated with the weight-loss drug Qnexa. But the agency also recognized the drug's ability to trigger significant weight loss, and analysts who have been following the therapy didn't immediately trigger any alarms about the risk analysis as VVUS shares soared in premarket trading. At extremely high doses, Qnexa--a combination of phentermine and the anti-convulsant topiramate--has been linked to...

Orexigen lands panel review as obesity drug race heats up

Orexigen Therapeutics (OREX) is getting an expert panel at the FDA to review its obesity drug Contrave. Long a subject of intense speculation in the blogosphere, the agency says that its advisory panel will sit down to review the drug on December 7, well ahead of its January 31st PDUFA date. "We look forward to the opportunity to present the findings from the Contrave clinical program and demonstrate the potential value of Contrave in treating patients with obesity," said Michael Narachi,...

Researchers make advances in understanding causes, treatments and outcomes of liver disease

NEW ORLEANS, LA (May 2, 2010) -- Non-alcoholic fatty liver disease (NAFLD), which may soon be the leading indication for liver transplant, is found to be significantly associated with worse transplant outcomes.read...

Role of protein pair in obesity regulation

New research implicates a new protein in obesity development and highlights a protein pair's "team effort" in regulating obesity and insulin...

New study shows effectiveness of MEND program in prevention and treatment of pediatric obesity

Ground-breaking results from a study to evaluate the effectiveness of the MEND Program (Mind, Exercise, Nutrition, Do it!), a multi-component community-based childhood obesity intervention, are published today in the US journal Obesity. The results coincide with the launch of Michelle Obama's initiative to reduce childhood obesity announced in the State of the Union speech. The independent study conducted by a team at University College London Institute of Child Health (ICH) demonstrates the...

New research on type 2 diabetes could benefit young adults with the condition

New research on Type 2 diabetes by Trinity College Dublin researchers could benefit young adults (aged 18-25 years) with the condition. The research led by Professor John Nolan of Trinity College Dublin and St James's Hospital, Dublin, has just been published online in the leading international journal, Diabetes Care.read...