On the heels of the FDA nod for Genzyme Corp.'s Campath for first-line use in chronic B-cell lymphocytic leukemia, Cephalon Inc. submitted its new drug application for the orphan drug Treanda, which targets CLL and is being developed for non-Hodgkin's lymphoma as well. (BioWorld Today)
Coming up with drugs that belong on the radar - and prescription pads - of primary-care doctors is "a challenge that biotech is treading carefully on," as Peter Hecht, CEO of Microbia Inc., told BioWorld Financial Watch last week, but Hecht's firm made a major footfall into the zone with its potential $330 million deal with Forest Laboratories Inc. (BioWorld Financial Watch)
The early stop thanks to efficacy of Millennium Pharmaceuticals Inc.'s Phase III trial with Velcade in new multiple myeloma patients left a key question unanswered, as the firm rolls toward a supplemental new drug application in the front-line setting "as fast we can, but by the first quarter of 2008," said Deborah Dunsire, president and CEO. (BioWorld Today)
Microbia Inc.'s potential $330 million deal - $70 million up front as a licensing fee - with Forest Laboratories Inc. for the Phase IIb gastrointestinal drug linaclotide could let the pair jump into the $500 million-plus market gap left earlier this year when Novartis AG pulled its compound for constipative irritable bowel syndrome, Zelnorm, off the shelves due to safety concerns. (BioWorld Today)