The Food and Drug Administration, often the center of attention for the U.S. biotech and medical device industries, came under the spotlight a bit more this week amid talk of changing the agency’s mission statement. There also was news from Amylin that should address at least some concerns FDA regulators have raised about its once-a-week treatment for diabetes.
—Shares of San Diego’s Amylin Pharmaceuticals (NASDAQ: AMLN) have gained more than 13 percent since Friday, when the company said its analysis of an earlier trial found no connection between its once-weekly injectable version of exenatide (Bydureon) and prolonged heart rhythms in 148 patients. At the American Diabetes Association’s annual conference in San Diego, Amylin also said another study showed that an earlier version of the drug, the twice-daily injectable version of exenatide (Byetta), was associated with a lower risk of heart failure. At the FDA’s request, the company is conducting another trial to specifically measure the drug’s effect on the QT interval, the time the heart’s electrical system takes to recharge after each beat. Amylin shares closed yesterday at $13.37, gaining $1.54 since closing last week at $11.83.
—San Diego-based Vital Therapies recently raised $22.6 million toward a possible $56.8 million Series D financing that combines equity, warrants and securities, according to a regulatory filing. The company has developed technology to stabilize liver function in patients with life-threatening, acute liver failure, through a process akin to dialysis that uses a proprietary filter to help regenerate healthy liver cells. Since the company was founded in 2003, Vital Therapies has raised about $40 million through three financing rounds. Versant Ventures is the lead investor.
—Independa, a wireless health startup founded in San Diego two years ago, said it’s making its integrated telecare app available for beta testing. The tablet-based system enables friends, relatives, and other caregivers to monitor an elderly loved one. The technology also uses a very simple interface for the elderly to send and receive e-mail, download photos, use other Web-based services.
—San Diego-based Verenium and St. Louis, MO-based Novus International said they are collaborating to develop and commercialize enzymes that can help farm animals and pets digest and absorb nutrients in grains and protein-based feed. Verenium, which has a library of industrial enzymes collected from around the world, also plans to move into a new facility atop Torrey Pines Mesa sometime next year.
—In his BioBeat column, Luke pondered the significance of reports that BIO, the life sciences industry group, has been working behind the scene to change the formal legal mission statement of the FDA. In a talk before home-state biotech leaders at the BIO conference earlier this week, Massachusetts Republican Sen. Scott Brown also said the FDA is “throwing a wet blanket” on innovative new drug discovery. Brown suggested that FDA regulators should consider whether people would die if the agency is slow to give its approval to a new drug.
—A new San Diego-area medical device startup, Acutus Medical, has raised $1 million in debt options and securities, according to a recent regulatory filing. Acutus Medical’s president and co-founder is Randy Werneth, who was previously a co-founder and vice president of engineering at Ablation Frontiers, a Carlsbad, CA, medical device company acquired by Minneapolis, MN-based Medtronic in early 2009 for $225 million. Acutus Medical is developing what Werneth has described only generally as “a breakthrough technology in electrophysiology.”
—San Diego-based TearLab, known previously as OccuLogix, raised $2.3 million in equity and options, according to a recent regulatory filing. As we reported last year, the company moved to San Diego from Toronto, to develop its lab-on-a-chip technologies used to diagnose disease markers in tears at the point-of-care. The company’s common shares trade on the NASDAQ Capital Market under the symbol TEAR and on the Toronto Stock Exchange under the symbol TLB.
—The San Diego-based West Wireless Health Institute named Robert Matthews as its chief technology officer. Matthews, who joins WWHI from Archinoetics, will oversee the institute’s biomedical engineering research and development strategy.