The FDA's stance on generics - at least on versions of the blood thinner Lovenox, such as Momenta Pharmaceuticals Inc.'s M-Enoxaparin (and probably similar compounds from Teva Pharmaceuticals Industries Ltd. and Amphastar Pharmaceuticals Inc. - became somewhat clearer last week, sadly and surprisingly for hanging-on Momenta investors who watched the stock's value tumble 58 percent, closing at $5.67. (BioWorld Financial Watch)

Riding on third-quarter profits that surprised some analysts thanks to the sale of its spray drug for menopause symptoms earlier this year, Vivus Inc. began the first of two pivotal Phase III trials with Qnexa, the combination phentermine/topiramate drug dosed once daily for obesity. (BioWorld Today)

Genelabs Technologies Inc.'s $23.7 million financing at the start of October sparked renewed interest in its Phase III drug Prestara for lupus - and in the indication itself, for which a new therapy based on randomized, placebo-controlled trials has not been approved in more than four decades. (BioWorld Financial Watch)

Wall Street nicked shares of Vertex Pharmaceuticals Inc. on word of results from two Phase IIb trials with its protease inhibitor telaprevir, as investors apparently were turned off by somewhat lower than expected sustained viral response (SVR), though the drug beat standard of care. (BioWorld Today)

Dynavax Technologies Corp.'s licensing deal with Merck & Co. Inc. to develop the Phase III hepatitis B virus vaccine Heplisav provides $31.5 million up front with $105 million in potential milestone payments plus royalties, as Dynavax continues managing the pivotal studies and the two firms gear up for a biologics license application filing, possibly in the first quarter of 2009. (BioWorld Today)