WASHINGTON – The FDA Thursday said it wants the HER2-negative metastatic breast cancer indication stricken from the labeling of Genentech Inc.'s Avastin (bevacizumab), which gained accelerated approval in February 2008 as a first-line treatment in combination with paclitaxel for the disease.
Catching Wall Street by surprise, Amgen Inc. reported top-line Phase III results showing Xgeva (denosumab) improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer (CRPC) vs. placebo – the first time a bone-targeted drug has delayed the spread of prostate cancer to the bones.
Infinity Pharmaceuticals Inc. is expected to garner an additional $110 million in 2012, on top of $65 million already banked this year and the $85 million anticipated in 2011, under an expanded deal with Mundipharma International Corp. Ltd., an independent European associated company of Purdue Pharmaceutical Products LP, to develop and commercialize IPI-926, Infinity's Smoothened (Smo) antagonist currently in Phase Ib/II testing, plus candidates arising from its phosphoinositol-3-kinase (PI3K) and discovery programs.
WASHINGTON – A district judge's interpretation of the Dickey-Wicker Amendment was "fundamentally flawed" when the court ruled that human embryonic stem cell (hESC) research was illegal, and therefore, the order should be reversed, a government lawyer argued last week before a three-judge panel from the U.S. Circuit Court of Appeals for the District of Columbia.
Shares of XenoPort Inc. tumbled 6.4 percent after the biotech priced a public offering of 4 million common shares at $7.15 per share, which was about 7.9 percent below Wednesday's closing price.
WASHINGTON – Investors in Orexigen Therapeutics Inc. Wednesday were not only bubbling over with excitement about an FDA panel's backing of the firm's obesity drug Contrave (naltrexone/bupropion) – with the company's stock rocketing as high as 129 percent – but shares of potential competitors Arena Pharmaceuticals Inc. and Vivus Inc. also were on fire, leaping as high as 20.5 percent and 19.5 percent, respectively.
SILVER SPRING, Md. – Beating the odds, Orexigen Therapeutics Inc. won the backing of an FDA panel Tuesday for approval of the company's weight-loss drug Contrave (naltrexone/bupropion) – the only drug out of three recently reviewed at the agency to gain the Endocrinologic and Metabolic Drugs Advisory Committee's blessing.
WASHINGTON – FDA drug reviewers in documents released Friday unsurprisingly focused on safety issues with Orexigen Therapeutics Inc.'s experimental weight-loss pill Contrave (naltrexone/bupropion), with the risks of adverse cardiovascular, psychiatric and cognitive events, along with seizures and increased serum creatinine among the agency's top concerns.
