Drug approvals and advances in new cancer therapies were the prevailing themes in San Diego’s life sciences news over the past week. Our briefing begins now.

—TEDMED, the exclusive medical and healthcare symposium that died in 2004 and was resurrected in 2009, is now the walking TEDMED. The entertaining show with a mix of big ideas, celebrity presentations, humor, and music that played at the Hotel del Coronado for the past three years said it is moving to Washington DC. Playing at the John F. Kennedy Center for the Performing Arts in the nation’s capital will give the $4,000-a-person symposium a bigger stage and a more influential audience, according to Priceline.com founder Jay Walker, who led an investor group that acquired the show in April. About 850 attended last week’s four-day symposium in the San Diego area.

—Federal regulators approved a new pain-killing drug intended to put off the post-surgical need for opioids that was developed by Pacira Pharmaceuticals (NASDAQ: PCRX), the Parsippany, NJ-based drug developer with operations in San Diego. The FDA’s approval marked the end to a protracted drug-development saga for the long-acting form of a pain drug called bupivacaine. Pacira plans to begin marketing the drug, branded as Exparel, in January.

—The FDA approved a new diagnostic test that was developed by San Diego-based Gen-Probe (NASDAQ: GPRO) to detect strains of the human papillomavirus (HPV) that pose a higher risk for cervical cancer and precancerous legions. Gen-Probe said regulators approved its Aptima HPV test to run on TIGRIS, a fully automated, high-throughput molecular diagnostic system. Using a Pap smear sample, the company says its test detects 14 high-risk types of HPV, giving patients and doctors information earlier and more accurately.

—Luke’s BioBeat column focused on several cancer drugs the FDA approved in August, which he suggested could be a turning point in the decades-long battle against cancer. Instead of broad-based anti-cancer drugs, Luke says regulatory approval of vemurafenib (Zelboraf), brentuximab vedotin (Adcetris), and crizotinib (Xalkori) signals the … Next Page »

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The Thanksgiving holiday helped to keep activity in San Diego’s life science companies at minimum levels over the past week. Still, what we picked up was interesting reading. Judge for yourself.

—San Diego’s Optimer Pharmaceuticals (NASDAQ: OPTR) filed a new drug application with the FDA for fidaxomicin, the drug it developed to treat patients with Clostridium difficile infection, the most common cause of diarrhea in hospitals. Optimer also asked for a priority review that takes six months instead of the usual 10. If granted, the FDA could issue a decision as early as the second quarter of 2011.

—San Diego’s Histogen said it has raised $10 million in Series A funding, which has enabled the life sciences startup to mount some mid-stage clinical trials of its regenerative medical treatements. The funding represents a comeback of sorts for Histogen, which was forced to lay off all 36 employees last year after rival SkinMedica of Carlsbad, CA, filed a patent infringement lawsuit against the startup.

—A life sciences industry survey by San Diego’s Biocom, Pricewaterhouse Coopers, and MassBio found that U.S. Food and Drug Administration officials are becoming more likely to change their position during the latter stage of the product review process. Sixty-three percent of the 50 companies participating in the study said the FDA had changed its position during at least one review, compared to 40 percent who made similar comments in a previous survey conducted in 2006.

—Aileron Therapeutics of Cambridge, MA, got exclusive rights to “click” chemistry technology that Nobel laureate K. Barry Sharpless developed at The Scripps Research Institute in San Diego. Click chemistry generates substances quickly and reliably by joining small reactive molecular building blocks together selectively to form extremely tight bonds. Financial terms were not disclosed.

—Roche terminated its collaboration and licensing agreement to develop a new treatment for hepatitis C with San Diego’s Ligand Pharmaceuticals (NASDAQ: LGNDD). Ligand and the Swiss pharmaceutical giant signed the deal two years ago.

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San Diego-based Somaxon said it submitted a revised application for its experimental sleeping pill doxepin (Silenor) to the FDA today, with a decision expected by March 21. The revised application addressed the agency’s questions about the efficacy of the drug in non-elderly adults, according to a Somaxon press release. The FDA has rejected Somaxon’s application to market doxepin twice.

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After reporting comprehensive findings from its major study of obesity drug lorcaserin 11 days ago, San Diego’s Arena Pharmaceuticals (NASDAQ: ARNA) said today it has arranged $100 million in debt financing with Deerfield Management, a significant shareholder.

That should provide the means for Arena to take the drug through the FDA drug review process. In a statement released this morning, Arena CEO Jack Lief says, “This funding will put us in a stronger financial position as we complete the lorcaserin Phase 3 pivotal program and prepare its NDA submission while advancing our various partnering discussions for lorcaserin and our earlier-stage drug candidates.” NDA stands for New Drug Application.

Deerfield Partner Howard Furst cited lorcaserin’s clean safety profile as “the single most important variable in the approval and broad usage of drugs” for the burgeoning population of overweight people in the U.S. In a comment that seemed to be aimed at investors, Furst added, “The value of Arena, however, goes beyond this important drug candidate to the company’s niacin receptor program with Merck, its diabetes program with Johnson & Johnson and its ability to discover, develop and partner additional compounds.”

Under terms of the credit facility, Deerfield, a New York-based healthcare investment firm, will provide Arena with $100 million, to be repaid within four years. The San Diego drug developer will issue Deerfield warrants for 28 million shares at a price of $5.42 a share.

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Amylin Pharmaceuticals (NASDAQ: AMLN), which is engaged in a proxy fight, has submitted a new drug application to the U.S. Food and Drug Administration for exenatide, its once weekly drug for type 2 diabetes. The San Diego biotech made the announcement today with Eli Lilly (NYSE: LLY), its marketing partner, and Cambridge, MA-based drug developing company Alkermes (NASDAQ: ALKS).

Amylin, Lilly, and Alkermes have been working to develop a new version of Byetta, the diabetes drug developed by Amylin, as a once-a-week injection based on Alkermes’ proprietary technology for long-acting medications.

“The clinical data supporting this submission highlight the potential of exenatide once weekly to significantly advance the treatment of type 2 diabetes,” says Amylin’s president and CEO Daniel Bradbury, according to the companies’ joint statement. “If approved, exenatide once weekly would be the first and only once-a-week therapy for the treatment of type 2 diabetes,” says David Vondle, Lilly’s global brand development leader.

Billionaire investor Carl Icahn and Eastbourne Capital Management, who together hold a 22 percent stake in Amylin, have targeted the San Diego biotech’s financial performance (and lagging Byetta sales) in their quest to gain more control on the company’s board. Amylin said yesterday it plans to lay off 200 employees in a restructuring of its sales force.

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