Expert panel set to review Boehringer’s Pradaxa

On September 20, an FDA expert panel will review Boehringer Ingelheim's Pradaxa (dabigatran), an experimental blood thinner that the company says is safer, more effective and simpler to use than the generic warfarin. The drug is indicated to prevent stroke in those with irregular heartbeats. It's good news for Boehringer, as some analysts speculated an expert panel wouldn't be scheduled to review Pradaxa until 2011. Bristol-Myers Squibb and partner Pfizer, Merck and Daiichi Sankyo are all...

New diabetes data highlights promising drug class

Aside from the closely-watched taspoglutide data, a slew of new reports came out of the ADA meeting on experimental diabetes drugs. Here's a sampling of the top news stories: Boehringer Ingelheim laid out data from five trials of its diabetes drug linagliptin, demonstrating lowered blood glucose compared to a placebo. Boehringer is hopeful that the therapy can compete against Januvia and Onglyza after proving that the DPP-4 inhibitor works effectively without having to adjust the dose to...

FDA experts unanimously reject Boehringer’s female libido pill

Undercut by a harsh regulatory assessment on both safety and efficacy, Boehringer Ingelheim's female libido pill was handed a decisive rejection by an expert FDA panel on Friday. The experts voted unanimously that Boehringer had not demonstrated an acceptable risk/benefit profile for the drug, setting the stage for an all-but-certain formal rejection by the FDA. FDA staffers had already concluded that the efficacy data on flibanserin's ability to stimulate women's sexual desire was...

FDA staffers raise doubts about Boehringer’s female libido drug

Just ahead of a June 18 FDA panel review, the FDA has released a staff review of Boehringer Ingelheim's sexual desire drug flibanserin, saying it may not be either safe or effective. Unlike male sex drugs, which are designed to stimulate the penis, Boehringer's therapy is aimed at the brain. The agency staffers concluded that the drug "failed to demonstrate a statistically significant improvement" and was linked to a range of side effects including appendicitis, depression, dizziness and loss...

FDA panel review looms for controversial libido drug

The first time researchers studied flibanserin, they thought they had a potential new depression therapy on their hands. That approach failed. But now Boehringer Ingelheim is preparing to make the case to a panel of FDA experts that the drug should be approved to boost women's libido, seeking an approval for a 'pink Viagra' that could earn up to $2 billion a year. The agency's views have yet to be heard, but there's already plenty of debate in women's health circles about the prospects of a new...

Boehringer looks to biotech for “targeted acquisitions”

Germany's Boehringer Ingelheim is planning to bring out the check book as it scours everything from early-stage biotechs to developers with marketed products for "targeted acquisitions" that can help the pharma company make up for the revenue being lost to new generic competitors. Boehringer appears eager to build on recent deals to acquire animal health assets from Pfizer and a Japanese OTC drug company. Biotechnology and start-ups are two key focus areas for new acquisitions, according...