The West Coast news of the past seven days was dominated by approvals. The FDA was responsible for two of them.
In San Diego, Orexigen Therapeutics traveled a long, long road with its weight-loss drug Contrave, and finally saw the FDA’s green light. But apparently investors didn’t approve; they threw the company’s stock price into reverse the next day. In San Francisco, Medivation won a label expansion for its prostate cancer treatment Xtandi. A far more satisfying approval was for the life’s work of University of Washington geneticist Mary-Claire King, who received one of the world’s top scientific honors from the Lasker Foundation. Previous winners Bill and Melinda Gates also made news—or more precisely, their eponymous foundation did, releasing $50 million to combat Ebola. With your approval, let’s move on to the roundup.
—On Wednesday the FDA approved Contrave, a weight-loss drug from Orexigen (NASDAQ: OREX) of San Diego. Contrave combines two drugs, already approved for other uses, in an extended-release formulation. The FDA designated Contrave for people who are obese or overweight with at least one weight-related health condition, following an approval process that took over four years. Despite the green light, the company’s share price fell nearly 11 percent Thursday. TheStreet.com’s Adam Feuerstein goes through some of the possible reasons here.
—After a swift review, San Francisco’s Medivation won a second approval for its prostate cancer treatment enzalutamide (Xtandi), which it co-owns with Japan’s Astellas Pharma. Enzalutamide, which is taken as a pill, first got the FDA’s nod in 2012 to treat patients with metastatic castration-resistant prostate cancer who had already undergone chemotherapy. The agency said Wednesday it can now be used to treat the same cancer but before chemotherapy—a much bigger population than the drug was previously approved for. Johnson & Johnson’s abiraterone (Zytiga) is the other oral prostate cancer drug on the market. A third is being developed by Tokai Pharmaceuticals, which is in line to go public, as we reported here.
—The Bill and Melinda Gates Foundation of Seattle announced Wednesday $50 million in emergency funds for the Ebola crisis in West Africa. The cash is to be distributed to health organizations and governments in the affected countries for emergency supplies and operations, as well as to groups conducting R&D for drugs, vaccines, and diagnostics. The amount for each has not been determined, but the foundation has already committed $5 million to the World Health Organization, $5 million to the U.S. Fund for UNICEF, and $2 million to the U.S. Centers for Disease Control. The Gates money adds to the public and private sector activity to create more therapeutic options to fight Ebola, which has ramped up in recent months in a mixture of grants and incentives, as Xconomy reports here.
—University of Washington geneticist Mary-Claire King won the 2014 Lasker-Koshland Special Achievement Award, one of the Lasker Foundation’s annual science prizes. King is being honored for a range of work, including the research that helped pinpoint the breast cancer gene BRCA1, and DNA work to find the “disappeared” victims of the Argentinian military dictatorship of the 1970s and 1980s. King will accept the award in New York September 19.
—Researchers at the UC San Diego School of Medicine have begun recruiting 40 patients for a first-of-its-kind clinical trial of a stem cell-derived therapy for patients with Type 1 diabetes developed by San Diego-based ViaCyte. The California Institute for Regenerative Medicine has provided … Next Page »