FDA Panel Votes Against Arena’s Weight-Loss Drug, ImThera Encouraged by Early Test Results, Novartis Wins FDA Approval for MS Pill, & More San Diego Life Sciences News
Much of San Diego’s life sciences news over the past week was about drug development and the FDA approval process. We’ve wrapped it up for you here.
—As setbacks go, this one was pretty substantial for San Diego’s Arena Pharmaceuticals (NASDAQ: ARNA) and its partner, Japan-based Eisai Pharmaceuticals. The Food and Drug Administration’s expert advisory panel on endocrinology and metabolic drugs voted 9-5 against recommending Arena’s weight-loss drug, lorcaserin, for sale in the United States. The FDA now has until October 22 to issue its ruling on the drug application.
—The FDA approved a drug application from Switzerland’s Novartis for a multiple sclerosis pill, which consumers might prefer to injected treatments for MS sold by Weston, MA-based Biogen Idec (NASDAQ: BIIB). Biogen Idec, which operates a facility in San Diego, is in late-stage development of its own MS pill, called BG-12.
—San Diego-based Gen-Probe (NASDAQ: GPRO) said it has submitted an application to the FDA for approval of its Progensa PCA3 test, which screens urine samples for a gene tied to prostate cancer. The medical diagnostics company said it plans to seek FDA approval for two more tests by the end of this year.
—ImThera Medical, a medical device maker in San Diego, revealed interim results from a European clinical study of its implanted neurostimulation unit for treating sleep apnea. The six-year-old startup called the results of tests from six patients “promising,” and says they are sleeping soundly with ImThera implants that deliver an electric current to the tongue.
—Vertex Pharmaceuticals (NASDAQ: VRTX), the Cambridge, MA-based developer with operations in San Diego, said it plans to raise about $375 million in a public debt offering due in 2015.
—Diagnostics services startup Molecular Response of San Diego named Cyrus Mirsaidi as CEO. The venture-backed company said its goal is to reduce risk and increase the efficacy of therapeutic drug development for its partners by identifying clinically relevant biological markers.
—Independa, a San Diego startup developing technology products and services to help senior citizens extend their independent living, emerged from stealth last week to say it has raised some new funding. The company did not disclose the amount or source.