|Medivation's David Hung.|
Friday, August 31, 2012
|Gilead CEO John Martin.|
Thursday, August 30, 2012
|Onyx CEO Tony Coles.|
Wednesday, August 29, 2012
Exelixis Inc.'s experimental cancer drug cabozantinib has been removed from the agenda of a Food and Drug Administration advisory committee meeting, the company said Wednesday, but the drug's potential approval date has not changed. Cabozantinib is the first drug from South San Francisco-based Exelixis (NASDAQ: EXEL) to get to this point in the approval process, but it is unclear whether the FDA's decision to remove it from the agenda of the Nov. 8-9 Oncologic Drugs Advisory Committee meeting ultimately could delay a final FDA decision whether to approve the drug. The FDA's decision date for cabozantinib continues to be Nov. 29.
Tuesday, August 28, 2012
|Medivation CEO David Hung.|
|Transcept CEO Glenn Oclassen.|
Monday, August 27, 2012
A wound-cleaning system from NovaBay Pharmaceuticals Inc. was cleared for wider use Monday by the Food and Drug Administration. The NeutroPhase skin and would cleanser and a related spray pump from Emeryville-based NovaBay (AMEX: NBY) were cleared through the FDA's 510(k) process for medical devices. NeutroPhase consists of hypochlorous acid, a common disinfectant, in normal saline.
A Redwood City company has received the U.S. Food and Drug Administration’s OK to start clinical trials for a device to treat emphysema. Pulmonx’s “Zephyr Endobronchial Valve” device is already commercially available in Europe. The company said in a press release Monday that it received an “investigational device exemption” from the FDA that will allow it to start a multi-center trial in the U.S. The results from the new trial will be used for a premarket approval application with the FDA.
Gilead Sciences Inc.'s four-in-one drug balm for HIV patients won Food and Drug Administration approval Monday. The pill, which Foster City-based Gilead (NASDAQ: GILD) will sell as Stribild, includes a new drug, called elvitegravir, and a new booster that allows elvitegravir to be given once a day. It also has two ingredients that the company already markets. Analysts have pegged Stribild as a potential $4 billion-a-year blockbuster.
CardioDx Inc. lined up $58 million in a two-tranche round – about $30 million now and the remainder later this year – as it expands following recently won Medicare coverage of its heart disease diagnostic test. Singapore-based investor Temasek joined a slew of existing CardioDx backers, including Kleiner Perkins Caufield & Byers, Mohr Davidow Ventures, TPG Biotech and GE Capital, in the financing, the Palo Alto company said Monday.
Genentech Inc.’s one-two cancer-fighting punch – an antibody-drug conjugate called T-DM1 – extended the lives of women with a type of metastatic breast cancer compared to patients on another therapy, the South San Francisco-based company said Sunday. Genentech, the U.S. subsidiary of Swiss drug maker Roche, did not disclose a specific length of time by which T-DM1, or trastuzumab emtansine, extended the lives of HER2-positive metastatic breast cancer patients over a group of patients given a combination of the drugs Tykerb and Xeloda. Genentech said it has submitted a biologics license application, which is similar to a new drug application, for T-DM1 to the Food and Drug Administration. An FDA decision on the drug could come by mid-2013. The agency in 2010 refused to consider Genentech’s application for accelerated approval based on data from a Phase II study.
Friday, August 24, 2012
Virolab Inc. Chairman Ricardo Rosales will take over as president and CEO, the startup genital warts vaccine developer said in a Securities and Exchange Commission filing Friday, replacing James A.D. Smith. Smith, the former president and CEO of Genelabs Technologies, resigned Aug. 5 for personal reasons, according to the filing, and Chief Financial Officer Matthew Loar left Aug. 13. Its executive vice president of regulatory affairs and quality,Mohammed Salem, left the company in January to become vice president of global regulatory coordination at Fresenius Medical Care in Waltham, Mass.
|Theravance CEO Rick Winningham.|
As Gilead Sciences Inc. nears approval this month of its four-in-one drug treatment for fighting HIV, a one-time ally has become an opponent. The AIDS Healthcare Foundation, which operates clinics, pharmacies and testing sites nationally, says the Quad pill from Foster City-based Gilead isn’t an improvement over current HIV drugs. What’s more, it dubs as “reckless” the recent, groundbreaking approval of Gilead’s two-in-one Truvada tablet as a way to prevent the AIDS virus. Pricing of Gilead’s portfolio of HIV-fighting drugs? Gilead should show restraint, AHF says. And while they’re at it, AHF says Gilead CEO John Martin’s compensation, which hit $15.6 million in 2011, is nothing more than "pharma greed." The foundation's issues involve the departure of a Gilead executive from the AHF board earlier this year as well as Gilead's decision to pull funding in June for two AHF programs. Perhaps most importantly, though, the campaign hasn't won AHF many friends in the AIDS patient advocacy community.
|SoundCure CEO Bill Perry.|
|Compugen's Mary Haak-Frendscho.|
Thursday, August 23, 2012
|StartX founder Cameron Teitelman.|
Wednesday, August 22, 2012
Xoma Corp. filed a shelf offering Wednesday that would let it sell $100 million worth of common stock, preferred stock, debt securities and warrants. Xoma plans to use the money for working capital and general corporate purposes, including research and development expenses and capital expenditures, it said in a Securities and Exchange Commission filing.
Xoma Corp. lead drug, gevokizumab, was granted orphan drug status for an inflammatory eye disease, the company said Wednesday. Orphan drug designation, awarded by the Food and Drug Administration for experimental treatments for diseases with fewer than 200,000 patients, allows Berkeley-based Xoma (NASDAQ: XOMA) to receive tax breaks for 50 percent of the cost of its clinical trials in non-infectious uveitis and pan-uveitis and FDA fee waiver. It also would receive seven years of U.S. market exclusivity if a drug is approved.
Tuesday, August 21, 2012
Gilead Sciences Inc.'s heart and lung disease drug cicletanine failed a mid-stage trial, Dow Jones reported Tuesday, and the company is discontinuing development of the drug. Foster City-based Gilead (NASDAQ: GILD) picked up cicletanine, aimed at pulmonary arterial hypertension patients, for an initial $10.9 million in May 2008 from Navitas Assets LLC.
Monday, August 20, 2012
Friday, August 17, 2012
|Relypsa's Gerrit Klaerner.|
Thursday, August 16, 2012
|Fluidigm President and CEO Gajus Worthington.|
Wednesday, August 15, 2012
|John B. Ford|
|Tjerk de Ruiter.|
Richard Brewer, a longtime biotech executive who helped to build companies such as Scios Inc., Dendreon Corp. and Nile Therapeutics Inc., died Wednesday morning from multiple myeloma.http://www.bizjournals.com/sanfrancisco/blog/biotech/2012/08/richard-dick-brewer-dendreon-nile-died.html
Monday, August 13, 2012
Vaccine maker Dynavax Technologies Corp. hired Christine Larson as chief financial officer, a new position at the company. The Berkeley company (NASDAQ: DVAX) hired Larson eight months after she quit PDL Biopharma Inc. (NASDAQ: PDLI), where she was also CFO and earned a salary of $400,000.
Pain management startup Prospira PainCare Inc. disclosed in a regulatory filing on Friday that it has raised nearly $23 million in a funding round in which it hopes to attract nearly $71 million. The Palo Alto-based company said in the filing with the Securities and Exchange Commission that it offered equity to raise the funds.
Fresh from the failure of an Alzheimer's disease drug, Elan Corp. plans to spin off its South San Francisco-based Neotope research organization into a separate company. Neotope was established in 2010 to identify targets for chronic degenerative diseases and other diseases, the company said, but the spinoff depends on approval by shareholders and holders of Elan's 2016 notes. If approved, Elan (NYSE: ELN)) said, a listing for Neotope Biosciences could be on a U.S. exchange by the end of this year. The company would be incorporated in Ireland, which also is Elan's home.
Timothy Guertin, CEO of Varian Medical Systems Inc., will retire Sept. 28, when the company's fiscal year ends. Dow Wilson, 53, will become president and CEO when Guertin, 62, steps down. Wilson is being promoted from chief operating officer. Varian hired him in 2005 to run its oncology systems business.
Friday, August 10, 2012
Michael Glynn, who joined Pacific Biosciences of California less than a year ago, is stepping down as chief commercial officer. The Menlo Park company (NASDAQ: PACB) broke the news Friday in a one-sentence filing with the Securities and Exchange Commission. The company did not say what prompted Glynn's resignation or hint at his personal plans.
|Kiverdi CEO Lisa Dyson.|
Genentech Inc.'s eye drug Lucentis won FDA approval Friday to treat diabetic patients for a blinding disease. South San Francisco-based Genentech, part of Swiss drug maker Roche, was recommended last month by a Food and Drug Administration advisory panel as a treatment for diabetic macular edema.
Thursday, August 9, 2012
Whether California's economy is broken, merely hobbled or on the road to recovery is a matter of debate, but one area in which state government has clearly failed is economic development. Jeff Gorell, a Republican Assembly member from Ventura County, thinks he has a solution. Working with Lt. Gov. Gavin Newsom, Gorell has put together what he calls "Gold Team California" to aggressively solicit out-of-state companies to move to California. It's a local effort, focused on Ventura County for now, but there's a distinct whiff of statewide politics in the air, too. If Gov. Jerry Brown and Newsom, the former San Francisco mayor, are going in different economic development policy directions -- or whether Newsom is simply trying to distance himself from unpopular Brown policies in his ultimate quest for the governor's seat -- this seems like a battleground.
|Talon's Steven Deitcher.|
Nodality Inc. scored a deal Thursday to help Pfizer Inc., the world's largest drug maker, better develop drugs. The multi-year deal, financial terms for which weren't disclosed, initially will focus on autoimmune diseases, particularly lupus. Plus, Pfizer has an option to use Nodality's technology to develop companion diagnostics.
Wednesday, August 8, 2012
A key national Medicare contractor will cover the cost of a coronary artery disease test developed by CardioDx Inc. The decision disclosed Tuesday by Palmetto GBA, a national contractor that administers Medicare benefits in Columbia, S.C., means that Medicare will cover the test for as many as 40 million enrollees. Coverage is retroactive to Jan. 1.
Tuesday, August 7, 2012
The Bay Area Council has hired former BayBio boss Matt Gardner as chief business officer, a role aimed at increasing the business group's membership. Gardner in fall 2009 resigned from BayBioafter six years at the helm of the Northern California life sciences trade group. Since then, he has been involved with a number of startup and technology-focused organizations.
|Adynxx founder Julien Mamet.|
Monday, August 6, 2012
Bapineuzumab, one of the drug-development industry's promising Alzheimer's disease treatments, failed in a late-stage trial, dealing another blow to the Alzheimer's community of patients, doctors and caregivers. The news came on the same day as researchers from the Gladstone Institutes in San Francisco said they discovered an already-approved anti-epilepsy drug that may eventually be used by Alzheimer's patients. Until then, however, bapineuzumab's second failure in four Phase III studies deals Alzheimer's patients another in a long string of disappointments. Partners Pfizer Inc. (NYSE: PFE) and Janssen Alzheimer Immunotherapy R&D LLC said they would discontinue their research of intravenous bapineuzumab in patients in mild to moderate stages of the disease.
Exelixis Inc. plans to offer 20 million shares and $225 million in debt, the South San Francisco biotech company said Monday. The company (NASDAQ: EXEL), which could win approval in late November for its cancer drug cabozantinib, saw its stock fall 13 percent after the news. On the day, Exelixis stock lost 73 cents, closing at $4.85 per share.
|Dr. Lennart Mucke of Gladstone and UCSF.|
Friday, August 3, 2012
Thursday, August 2, 2012
Hayward's Solta Medical Inc. will raise about $14 million by selling stock. The company (NASDAQ: SLTM) -- born in 1996 as Thermage Inc. -- lost $26.3 million in the June quarter on sales of $37.3 million. It makes devices to treat acne or to tighten skin using radiofrequency energy and heat or lasers. It signed a commitment letter last week with Silicon Valley Bank for a $10 million debt facility.
Gilead Sciences Inc. will work with three Indian drug makers to promote access to a chunk of its portfolio of approved HIV-fighting treatments in developing countries. Under the deal announced Thursday, Foster City-based Gilead (NASDAQ: GILD) will turn over technology to Mylan Laboratories, Ranbaxy Laboratories Ltd. and Strides Acrolab needed to make Gilead's emtricitabine, or Emtriva.
Wednesday, August 1, 2012
The Energy Biosciences Institute has started to move into a newly finished $130 million building on the campus of the University of California, Berkeley. The EBI is a $500 million public-private joint venture funded by oil company BP plc (NYSE: BP). EBI is a partnership between UC Berkeley, the University of Illinois in Urbana-Champaign, and Lawrence Berkeley National Laboratory. About 300 people are moving into the building over the next six weeks. Admin staff and some laboratory programs are moving first.
|Burrill & Co.'s G. Steven Burrill.|