If the FDA greenlights Vivus Inc.'s Qnexa next week, it won't just be giving the market go-ahead to a second obesity drug. It will be opening up a new lane for weight-loss drugs containing an anticonvulsant. Read More
Shionogi-ViiV Healthcare LLC's HIV drug dolutegravir beat Gilead Sciences Inc.'s Atripla in a Phase III trial in treatment-naive adults with HIV-1 infection. Initial results showed that 88 percent of patients receiving dolutegravir with Kivexa/Epzicom (abacavir/lamivudine) were virologically suppressed, compared to 81 percent on Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate). Read More
Researchers have identified a gene variant that is protective against both late-onset Alzheimer's disease and age-related cognitive decline. Beyond its scientific novelty, the work provides a proof of concept that inhibiting beta-secretase, or BACE1, can be effective against both Alzheimer's disease and age-related cognitive decline – because that is the net effect of the variant that senior author Kari Stefansson and his team have identified. Read More
Orphan Synergy Europe (OSE) Pharma SA came out of the starting gate with a Phase II candidate, in-licensing a therapeutic cancer vaccine discovered at San Diego-based Epimmune Inc. that had languished following that company's 2005 merger with Immuno-Designed Molecules (IDM) SA, of Paris. Read More
• Gradalis Inc., of Dallas, signed a collaboration agreement with Baylor College of Medicine for the use of Gradalis' bifunctional shRNA platform for research into therapeutic targets in cancer. Under the agreement, Gradalis will contribute shRNA constructs targeted at specific proteins of interest and access to other technologies, including SuperClean DNA, reversible masking, liposomal delivery and liposomal targeting. Read More
• ImmunoGen Inc., of Waltham, Mass., said it started a Phase I trial of IMGN853, a TAP (Targeted Antibody Payload) compound comprising an FOLR1-targeting antibody attached to cell-killing agent DM4, in patients with ovarian cancer or other solid tumors that overexpress FOLR1, including non-small-cell lung cancer. Once the maximum-tolerated dose is established, the activity of the compound will be evaluated in disease-specific patient cohorts. Read More
• Teva Pharmaceutical Industries Ltd., of Jerusalem, said the UK's High Court of Justice issued a decision in favor of Teva in a patent litigation proceeding against Generics (UK) Ltd., a subsidiary of Mylan Laboratories Inc., of Pittsburgh. Read More
• Eli Lilly and Co., of Indianapolis, reported negative results from study H8Y-MC-HBBM investigating pomaglumetad methionil, also known as mGlu2/3, in patients with acute exacerbations of schizophrenia. Read More
