Stock in Nabi Biopharmaceuticals Inc. plunged 66.4 percent Monday on news that its smoking cessation vaccine, NicVAX, missed its primary endpoint in a Phase III trial. Participants in the double-blinded, placebo-controlled trial of 1,000 people quit smoking at a similar rate whether they were randomized to the vaccine or placebo group, about 11 percent. The company expressed surprise and disappointment, and is awaiting results of its second Phase III trial. Read More
Only days after Seattle Genetics Inc. earned unanimous backing from an advisory panel for its Adcetris (brentuximab vedotin) in two lymphoma indications based on single-arm studies, another company is testing the FDA's accelerated approval pathway. Read More
LONDON – SEEK Ltd. has reached clinical proof of efficacy in a Phase Ib/II trial of its HIV-v vaccine, showing a 90 percent reduction in viral load in HIV-infected volunteers. Read More
Transcept Pharmaceuticals Inc., of Point Richmond, Calif., is eliminating approximately 45 percent of its work force as it looks to conserve cash following the receipt of its second complete response letter from the FDA for insomnia drug Intermezzo (zolpidem tartrate sublingual tablet). Read More
Merck & Co. Inc., of Whitehouse Station, N.J., reported final results from a Phase II study, extending out to 240 weeks, of its integrase inhibitor Isentress (raltegravir) in combination therapy in treatment-naive adult HIV-1-infected patients. Read More