Is sentiment coming together to push for FDA regulatory reform? Luke’s BioBeat column described industry efforts to shake up the FDA, and U.S. Rep. Darell Issa convened a hearing in San Diego last to collect life sciences testimony on needed reforms. We have details on all that and more.
—In a run-up to an FDA public advisory meeting today in Silver Springs, MD, Luke reported that an FDA staff analysis of data submitted for a new hepatitis C drug under development at Cambridge, MA-based Vertex shows a cure rate as high as 79 percent among patients getting their first-round of treatment. That’s better than the 75 percent cure rate reported by Vertex, which has substantial operations in San Diego. The question lingering today is whether two side effects cited by the FDA—rash and anemia—will affect the advisory panel’s recommendation concerning the Vertex drug, telaprevir.
—Dow Jones VentureSource provided more details about first-quarter venture capital activity in San Diego, including data about local life sciences deals. In contrast to the MoneyTree Report, which shows a sharp decline, Dow Jones says venture funding in San Diego was relatively flat, with $213.9 million invested in 26 deals. That includes $119.6 million invested in 13 healthcare companies in San Diego, which is almost even with the $121.6 million that was invested in 12 healthcare companies during the same quarter of 2010.
—San Diego’s Polaris Group, which seemed to spring out of nowhere, is moving to begin a late-stage clinical trial of ADI-PEG 20 for treating the most common type of liver cancer. The drug, also known as pegylated arginine deiminase, is intended to deprive tumor cells of arginine, an essential amino acid they need to survive and grow.
—San Diego’s Fate Therapeutics, which is developing stem cell therapies, has increased the size of its current equity round to $36 million and arranged for $1 million in debt financing, according to a couple of recent regulatory filings. Fate said in February that chairman John Mendlein was stepping in to run the company following the departure of CEO Paul Grayson, who is leaving to form a new company.
—Rep. Darrell Issa, the San Diego area Republican congressman who is now chairman of the House Oversight and Government Reform Committee, convened a hearing in San Diego last week to collect testimony from local life sciences innovators. Issa, who was joined by Democrat Susan Davis of San Diego and fellow Republicans Brian Bilbray of Solana Beach, CA, and Duncan D. Hunter of Alpine, CA, heard testimony about overly cautious regulators, burdensome taxes, and threats to basic science research funding. David Gollaher of the California Healthcare Institute in La Jolla testified that venture capital firms avoid whole areas of drug development because the regulatory barriers are too high, according to The San Diego Union-Tribune.
—In a related vein, Luke’s BioBeat column described efforts by the National Venture Capital Association and medical device trade groups to shake up the FDA’s regulatory mindset. Luke, who talked with Ross Jaffe of Versant Ventures in Menlo Park, CA, says the industry has been offering more data to back up its call for regulatory reform. And he says it appears to be working.
—San Diego’s Illumina (NASDAQ: ILMN) joined Lansdowne Partners, IP Group, Invesco Perpetual, Redmile Group, and other undisclosed investors in making a $41 million additional investment in U.K.-based Oxford Nanopore. Illumina is the world’s biggest maker of high-speed gene sequencing machines.
—Proteostasis Therapeutics, founded in Cambridge, MA with technology to fight neurodegenerative diseases from The Scripps Research Institute in San Diego, has obtained two exclusive technology licenses from Harvard University.
—The FDA approved orphan drug status for AM152, the lead drug candidate under development at Amira Pharmaceuticals. The San Diego startup is developing a treatment for idiopathic pulmonary fibrosis, a lung disease that makes it difficult to breathe.