Perhaps Genentech has a new slogan in the works: Have companion diagnostic, will travel.
The South San Francisco-based U.S. subsidiary of Swiss drug maker Rochefor the past couple years has mandated its research arm to tie in companion diagnostics with drug development. That extends to Genentech partnerships as well, said James Sabry, vice president of partnering for Genentech.
Thursday, June 30, 2011
Bay Area transplant Sorbent Therapeutics closes $53M Series B financing
Sorbent Therapeutics Inc. closed a $53 million Series B financing round led by new investor Novartis Venture Funds.
A Bay Area transplant from Chicago, the three-employee Sunnyvale company will use the money to complete a mid-stage program for its lead congestive heart failure drug and slowly add a few employees, CEO Detlef Albrecht said.
A Bay Area transplant from Chicago, the three-employee Sunnyvale company will use the money to complete a mid-stage program for its lead congestive heart failure drug and slowly add a few employees, CEO Detlef Albrecht said.
Wednesday, June 29, 2011
Reaction to FDA's Avastin decision
Here's some of the reaction from Wednesday's Food and Drug Administration advisory panel recommendation to revoke approval of Avastin, developed by South San Francisco's Genentech, for women with metastatic breast cancer.
FDA panel votes against Genentech's Avastin
A regulatory panel recommended Wednesday that approval of Genentech Inc.’s cancer-fighting drug Avastin be revoked for women with breast cancer that has spread to other parts of the body.
The Food and Drug Administration panel in a 6-0 vote said two followup clinical trials did not verify the clinical effect of Avastin for women with metastatic breast cancer.
The final say rests with FDA Commissioner Margaret Hamburg, likely later this summer. The decision could shave about $1 billion in revenue off of Avastin, the world’s best-selling cancer drug.
The Food and Drug Administration panel in a 6-0 vote said two followup clinical trials did not verify the clinical effect of Avastin for women with metastatic breast cancer.
The final say rests with FDA Commissioner Margaret Hamburg, likely later this summer. The decision could shave about $1 billion in revenue off of Avastin, the world’s best-selling cancer drug.
Bitten by Avastin, will FDA shy away from conditional approvals?
Should Genentech ’s cancer-fighting drug Avastin stay on the market for women with metastatic breast cancer?
When all is said and done, this decision comes down to statistics and rules, and as one speaker said Tuesday, the same rules that allow accelerated approval allow accelerated disapproval. The same FDA and the same Richard Pazdur allowed Avastin onto the market conditionally; they opened the door based on statistics that said women could benefit from Avastin.
They also can close that door, again based on cold, hard numbers, not emotion.
But what's the fallout on companies using the accelerated approval process in the future, and what's the impact on the FDA?
When all is said and done, this decision comes down to statistics and rules, and as one speaker said Tuesday, the same rules that allow accelerated approval allow accelerated disapproval. The same FDA and the same Richard Pazdur allowed Avastin onto the market conditionally; they opened the door based on statistics that said women could benefit from Avastin.
They also can close that door, again based on cold, hard numbers, not emotion.
But what's the fallout on companies using the accelerated approval process in the future, and what's the impact on the FDA?
Tuesday, June 28, 2011
Avastin protest videos: Outrage, emotion and Dylan
They took a while to upload, but here — finally — are the videos I shot of Tuesday morning's protest in support of Genentech 's cancer drug Avastin.
Protesters gathered around 7 a.m., in advance of the Food and Drug Administration's hearing Tuesday and Wednesday on the agency's plan to rescind Avastin's conditional approval for metastatic breast cancer. One of the highlights was a '60s-like protest song that might make Bob Dylan proud.
Protesters gathered around 7 a.m., in advance of the Food and Drug Administration's hearing Tuesday and Wednesday on the agency's plan to rescind Avastin's conditional approval for metastatic breast cancer. One of the highlights was a '60s-like protest song that might make Bob Dylan proud.
Anacor, partners target African sleeping sickness
A public-private-nonprofit partnership, including Palo Alto’s Anacor Pharmaceuticals Inc. , has completed early work on the first new oral drug candidate discovered specifically to combat sleeping sickness.
Anacor (NASDAQ: ANAC), Scynexis of North Carolina and the Drugs for Neglected Diseases Initiative on Tuesday published results of their preclinical studies in the journal PLos Neglected Tropical Diseases.
Phase I clinical trials in humans will start soon.
Anacor (NASDAQ: ANAC), Scynexis of North Carolina and the Drugs for Neglected Diseases Initiative on Tuesday published results of their preclinical studies in the journal PLos Neglected Tropical Diseases.
Phase I clinical trials in humans will start soon.
Gilead, Tibotec to work on new HIV-fighting combos
Gilead Sciences Inc. will combine its experimental booster with a protease inhibitor from Tibotec Pharmaceuticals in a new HIV-fighting drug.
What’s more, Foster City-based Gilead (NASDAQ: GILD) and Johnson & Johnson unit Tibotec said they are negotiating terms for developing and commercializing another tablet that combines the same Tibotec protease inhibitor, Prezista, with the already-approved Gilead HIV drug Emtriva, the new booster, called cobicistat, and a Gilead investigational drug, known as GS-7340.
What’s more, Foster City-based Gilead (NASDAQ: GILD) and Johnson & Johnson unit Tibotec said they are negotiating terms for developing and commercializing another tablet that combines the same Tibotec protease inhibitor, Prezista, with the already-approved Gilead HIV drug Emtriva, the new booster, called cobicistat, and a Gilead investigational drug, known as GS-7340.
Day 1: Avastin patients, families protest ahead of FDA hearing
Genentech Inc. ’s cancer-fighting Avastin is in front of a Food and Drug Administration panel today, a struggle that has inspired breast cancer patients and their families.
The hearing — today and Wednesday at the FDA campus in Silver Spring, Md. — will go a long way toward determining if Avastin will win full approval for metastatic breast cancer patients.
Thirty-five people signed up to make public presentations, said Karen Midthun of the FDA, who is presiding over the hearing.
Final submissions by Genentech and the FDA will continue until July 28. FDA Commissioner Margaret Hamburg will make the final decision.
The hearing — today and Wednesday at the FDA campus in Silver Spring, Md. — will go a long way toward determining if Avastin will win full approval for metastatic breast cancer patients.
Thirty-five people signed up to make public presentations, said Karen Midthun of the FDA, who is presiding over the hearing.
Final submissions by Genentech and the FDA will continue until July 28. FDA Commissioner Margaret Hamburg will make the final decision.
Monday, June 27, 2011
Genentech warms biotechs, shareholders with deals
The big biotech financing chill isn’t necessarily thawing after three years, but companies at least are finding creative ways to warm shareholders.
An example: Genentech Inc.’s deal Monday with Forma Therapeutics. The “asset acquisition” deal is a unique way of putting money in the hands of Cambridge, Mass.-based Forma’s backers — including the likes of Lilly Ventures and Bio-One Capital of Singapore — while giving South San Francisco-based Genentech control over development of a potential cancer treatment.
An example: Genentech Inc.’s deal Monday with Forma Therapeutics. The “asset acquisition” deal is a unique way of putting money in the hands of Cambridge, Mass.-based Forma’s backers — including the likes of Lilly Ventures and Bio-One Capital of Singapore — while giving South San Francisco-based Genentech control over development of a potential cancer treatment.
Away from BIO's glare, Xoma, Tethys tackle diabetes
It ain’t BIO, but the American Diabetes Association’s big scientific meeting in San Diego may be just as important to a couple of East Bay life sciences companies.
Some 2,700 miles away from this week's Biotechnology Industry Organization’s shindig in Washington, D.C., the ADA meeting has given Berkeley’s Xoma Ltd. and Emeryville-based Tethys Bioscience Inc . a platform for news.
Some 2,700 miles away from this week's Biotechnology Industry Organization’s shindig in Washington, D.C., the ADA meeting has given Berkeley’s Xoma Ltd. and Emeryville-based Tethys Bioscience Inc . a platform for news.
Takeda venture arm invests in Redwood Bioscience
The venture arm of Japan’s Takeda Pharmaceutical Co. Ltd. will fund further development of a protein-modification technology from Redwood Bioscience Inc.
Redwood, of Burlingame, said the undisclosed amount from Takeda Ventures Inc. will be used to forward the company’s protein-chemical engineering technology, which could be used to better deliver drugs with better potency.
Redwood, of Burlingame, said the undisclosed amount from Takeda Ventures Inc. will be used to forward the company’s protein-chemical engineering technology, which could be used to better deliver drugs with better potency.
After FDA rejection, Pain Therapeutics says drug approval could take year or more
Regulators' rejection of a tamper-resistant pain drug from Pain Therapeutics Inc.and Pfizer Inc. could delay approval of the drug for a year or more.
San Mateo-based Pain Therapeutics (NASDAQ: PTIE) said the Food and Drug Administration cited the inconsistent release of some lots of Remoxy, designed to be a sustained-release version of oxycodone.
San Mateo-based Pain Therapeutics (NASDAQ: PTIE) said the Food and Drug Administration cited the inconsistent release of some lots of Remoxy, designed to be a sustained-release version of oxycodone.
Genentech cancer deal kicks off BIO convention
Now this is the way to get this BIO party started.
South San Francisco biotech powerhouse Genentech is buying into a preclinical cancer-fighting program from Forma Therapeutics of Cambridge, Mass. As it turns out, Genentech’s partnering chief, James Sabry, is on my talk-to list today, the first day of the Biotechnology Industry Organization convention in Washington, D.C.
South San Francisco biotech powerhouse Genentech is buying into a preclinical cancer-fighting program from Forma Therapeutics of Cambridge, Mass. As it turns out, Genentech’s partnering chief, James Sabry, is on my talk-to list today, the first day of the Biotechnology Industry Organization convention in Washington, D.C.
Genentech buys into Forma cancer drug program
Genentech Inc. will buy the rights to a preclinical program that zeroes in on a single cancer target from Forma Therapeutics.
Specific financial terms of the deal weren’t disclosed, but South San Francisco-based Genentech will make an upfront payment and be responsible for all development work. Genentech will have the option to buy the entire program from Forma.
Specific financial terms of the deal weren’t disclosed, but South San Francisco-based Genentech will make an upfront payment and be responsible for all development work. Genentech will have the option to buy the entire program from Forma.
Monday, June 13, 2011
Amgen's David Lacey looks to shift gears
David Lacey will have more time to bicycle along the Central Coast and sip a little wine. But don’t expect Amgen Inc.’s soon-to-retire discovery research chief and South San Francisco site head to get lost on the backroads.
A little more than a year ago, the 58-year-old Lacey started talking to Roger Perlmutter, Amgen’s executive vice president of research and development, more seriously about retiring.
“There are things I want to do, and with the dispersion of this job, you’re share of mind has got to be 100 percent on what the job is,” Lacey said.
But all good bicyclists on a long ride take care to map their routes in advance — with a little wiggle room for exploration — and Lacey is no exception.
A little more than a year ago, the 58-year-old Lacey started talking to Roger Perlmutter, Amgen’s executive vice president of research and development, more seriously about retiring.
“There are things I want to do, and with the dispersion of this job, you’re share of mind has got to be 100 percent on what the job is,” Lacey said.
But all good bicyclists on a long ride take care to map their routes in advance — with a little wiggle room for exploration — and Lacey is no exception.
Alios lands $60M in hepatitis C licensing deal with Vertex
Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) and Alios BioPharma Inc. on Monday announced a licensing agreement, adding two distinct nucleotide analogues to Vertex’s hepatitis C portfolio. The compounds, discovered by Alios and known as ALS-2200 and ALS-2158, are potential treatments of the hepatitis C virus.
As part of the agreement, Vertex will make an up-front payment of $60 million to South San Francisco-based Alios, in exchange for the worldwide rights to ALS-2200 and ALS-2158. Vertex will take on development costs and research funding, as well as up to $715 million in milestone payments if both compounds are approved. Cambridge, Mass.-based Vertex already expects to pay about $35 million in development milestones in 2011.
Alios is also eligible to receive up to $750 million in sales milestones.
As part of the agreement, Vertex will make an up-front payment of $60 million to South San Francisco-based Alios, in exchange for the worldwide rights to ALS-2200 and ALS-2158. Vertex will take on development costs and research funding, as well as up to $715 million in milestone payments if both compounds are approved. Cambridge, Mass.-based Vertex already expects to pay about $35 million in development milestones in 2011.
Alios is also eligible to receive up to $750 million in sales milestones.
Via starts cholesterol treatment trial
Via Pharmaceuticals Inc. started an early safety test of a treatment for high LDL cholesterol.
The San Francisco drug company (Pink Sheets: VIAP) is testing the drug VIA-3196 in healthy volunteers at a center in Fargo, N.D. There will ultimately be about 72 people in this test. They’ll each get a single dose of the drug.
The San Francisco drug company (Pink Sheets: VIAP) is testing the drug VIA-3196 in healthy volunteers at a center in Fargo, N.D. There will ultimately be about 72 people in this test. They’ll each get a single dose of the drug.
Accuray completes $277M TomoTherapy acquisition
Accuray Inc. wrapped up its $277 million acquisition of TomoTherapy Inc.
Sunnyvale-based Accuray (NASDAQ: ARAY), which went public in 2007, makes laser cancer surgery technology under the “CyberKnife” brand. TomoTherapy, based in Madison, Wis., makes radiation treatment systems for cancer.
As a combined business, they’ll have 1,100 people working for them and will have combined sales of about $400 million a year.
Sunnyvale-based Accuray (NASDAQ: ARAY), which went public in 2007, makes laser cancer surgery technology under the “CyberKnife” brand. TomoTherapy, based in Madison, Wis., makes radiation treatment systems for cancer.
As a combined business, they’ll have 1,100 people working for them and will have combined sales of about $400 million a year.
Sunday, June 12, 2011
David Lacey to retire as Amgen SVP of discovery research, South SF site head
David Lacey, Amgen Inc.’s South San Francisco chief and senior vice president of discovery research for the company overall, will retire.
Lacey, 58, was not immediately available to talk about his plans, but is expected to take on new roles in the life sciences industry that allow him more time with his family. It was not clear when Lacey's retirement would take effect.
Employees have described Lacey, who joined Amgen (NASDAQ: AMGN) in 1994 from Washington University and spent 12 years at the company's Thousand Oaks headquarters, as a "cornerstone" of the company. He moved to the South San Francisco site in 2006.
Lacey, 58, was not immediately available to talk about his plans, but is expected to take on new roles in the life sciences industry that allow him more time with his family. It was not clear when Lacey's retirement would take effect.
Employees have described Lacey, who joined Amgen (NASDAQ: AMGN) in 1994 from Washington University and spent 12 years at the company's Thousand Oaks headquarters, as a "cornerstone" of the company. He moved to the South San Francisco site in 2006.
Friday, June 10, 2011
Returning (sort of) in time for BIO
BiotechSF will be taking two weeks off, heading to Michigan to see family and friends and then driving(!) back to San Francisco. All 2,900 miles of it. With my 7-year-old son.
When (if?) I return — just in time to take off, again, for the BIO convention in Washington, D.C. — there will be dramatic changes to BiotechSF.
In the meantime, continue to read the San Francisco Business Times and Silicon Valley/San Jose Business Journal for Bay Area life sciences (and a whole lot more) news.
For those of you looking to set up time to meet at the BIO convention, please reach out to me via email: rleuty@bizjournals.com.
When (if?) I return — just in time to take off, again, for the BIO convention in Washington, D.C. — there will be dramatic changes to BiotechSF.
In the meantime, continue to read the San Francisco Business Times and Silicon Valley/San Jose Business Journal for Bay Area life sciences (and a whole lot more) news.
For those of you looking to set up time to meet at the BIO convention, please reach out to me via email: rleuty@bizjournals.com.
Skin care therapy company Revance Therapeutics cleans up with $45M financing
Revance Therapeutics Inc. has closed a $45 million round of financing led by Palo Alto-based Essex Woodlands Health Ventures and a new investor, NovaQuest Capital, the company said Friday.
Gilead in line to start 1st building in big campus buildout
The first phase of a dense remake of Gilead Sciences Inc.’s Foster City headquarters campus will begin this year with construction of the first of seven potential new buildings.
The world’s largest developer of HIV treatments plans to raze two buildings totaling 58,000 square feet to build a four-story, 192,054-square-foot lab structure on Lakeside Drive. In all, Gilead expects to double its campus footprint to 1.2 million square feet over several years.
The world’s largest developer of HIV treatments plans to raze two buildings totaling 58,000 square feet to build a four-story, 192,054-square-foot lab structure on Lakeside Drive. In all, Gilead expects to double its campus footprint to 1.2 million square feet over several years.
New Wareham building on track to ease biotech space crunch in Emeryville
Wareham Development Corp. is on track to deliver a new building a year from now to Emeryville’s tight bioscience market at a time when demand from tenants is heating up.
The developer started construction a few months ago on the 94,000-square-foot EmeryStation Greenway Building at 5800 Hollis St.
The developer started construction a few months ago on the 94,000-square-foot EmeryStation Greenway Building at 5800 Hollis St.
Race is on for next-generation COPD drugs, but real payoff may be years away
Racing to get to market with new treatments for a common lung disease, drug developers may see an even more lucrative finish line further ahead.
First, however, drug developers are pushing new combinations of existing drugs or easier-to-use formulations.
First, however, drug developers are pushing new combinations of existing drugs or easier-to-use formulations.
Wednesday, June 8, 2011
Anthem boosts coverage of XDx heart transplant test
Anthem Blue Cross and Blue Shield, the single largest commerical insurer in the United States, will systematically cover heart transplant patients’ use of a test from Brisbane’s XDx Inc. that determines the risk of transplant rejection.
The AlloMap blood test from privately held XDx measures expression levels of 20 genes, allowing doctors to skip invasive tissue-sampling biopsies to determine if a transplanted heart is being rejected.
Anthem’s determination that the test is “medically necessary” is an important milestone for XDx, meaning that the test is covered systematically and not just on a case-by-case basis.
The AlloMap blood test from privately held XDx measures expression levels of 20 genes, allowing doctors to skip invasive tissue-sampling biopsies to determine if a transplanted heart is being rejected.
Anthem’s determination that the test is “medically necessary” is an important milestone for XDx, meaning that the test is covered systematically and not just on a case-by-case basis.
Roche Molecular Diagnostics, Merck ink cancer assay deal
Roche Molecular Diagnostics will develop diagnostic assays for Merck & Co. that will help the drug giant developer cancer drugs.
Financial terms of the deal between Pleasanton-based Roche Molecular Diagnostics and Merck (NYSE: MRK) were not disclosed.
Financial terms of the deal between Pleasanton-based Roche Molecular Diagnostics and Merck (NYSE: MRK) were not disclosed.
McKesson, Hearst sued by Michigan AG over drug pricing
Michigan is suing San Francisco-based drug and medical products distributor McKesson Corp. and Hearst Corp., saying they conspired to artificially inflate wholesale prices and cost the state millions of dollars in Medicaid reimbursements.
Michigan Attorney General Bill Schuette alleged that McKesson and Hearst, which owns First DataBank Inc. of South San Francisco as well as the San Francisco Chronicle, violated the Michigan Medicaid False Claims Act by knowingly publishing false average wholesale prices for certain medicines from late 2001 through September 2009.
Michigan Attorney General Bill Schuette alleged that McKesson and Hearst, which owns First DataBank Inc. of South San Francisco as well as the San Francisco Chronicle, violated the Michigan Medicaid False Claims Act by knowingly publishing false average wholesale prices for certain medicines from late 2001 through September 2009.
MedComm Solutions sold to Milwaukee's Dohmen
Emeryville’s MedComm Solutions LLC has been sold to Dohmen, a 153-year-old healthcare services business.
Milwaukee-based Dohmen Co. didn’t say what it paid for MedComm, which it bought through its Dohmen Investment Group.
MedComm runs call centers that answer questions from customers of drug companies. The company handles product complaints and also keeps track of any adverse drug side effects. It also sometimes helps drug companies recruit and randomize people for clinical trials.
Milwaukee-based Dohmen Co. didn’t say what it paid for MedComm, which it bought through its Dohmen Investment Group.
MedComm runs call centers that answer questions from customers of drug companies. The company handles product complaints and also keeps track of any adverse drug side effects. It also sometimes helps drug companies recruit and randomize people for clinical trials.
Tuesday, June 7, 2011
One-on-one with David Parke of the American Academy of Ophthalmology
Much was made of a National Eye Institute study in April that compared two Genentech Inc. drugs in patients with wet age-related macular degeneration, a leading cause of blindness. The so-called CATT — Comparison of Treatment Trials — study of 1,185 patients showed that Avastin, which costs about $50 per injection, is as effective in treating wet AMD as Lucentis, which costs about $2,000 per injection. The big difference is that Lucentis is approved for wet AMD; Avastin is not. But Dr. David Parke II, CEO of the San Francisco-based American Academy of Ophthalmology, isn’t looking at the data as an either-or proposition.Parke speaks to San Francisco Business Times biotech reporter Ron Leuty about the CATT study, eye diseases and his organization.
Investors insert $25.5M into medical device company Arstasis
Medical device company Arstasis Inc. won a $25.5 million investment from undisclosed investors in a Series E financing.
The Redwood City company said the cash, raised from both new and returning investors, would allow it to complete the launch of the Axera Access Device and continue development of products in its pipeline.
The Redwood City company said the cash, raised from both new and returning investors, would allow it to complete the launch of the Axera Access Device and continue development of products in its pipeline.
Vaxart starts early-stage oral vaccine trial
Vaccine delivery company Vaxart Inc. started dosing the first volunteers in a 54-patient Phase I safety trial of its oral vaccine, designed to protect against a strain of the Avian flu.
The trial is important for the San Francisco company, said founder and Chief Scientific Officer Sean Tucker, because if the vaccine proves safe in this first trial of the company’s technology, “we can expect that later vaccines using the same Vaxart technology will also be safe.”
The trial is important for the San Francisco company, said founder and Chief Scientific Officer Sean Tucker, because if the vaccine proves safe in this first trial of the company’s technology, “we can expect that later vaccines using the same Vaxart technology will also be safe.”
BioMarin starts Phase III trial in rare LEMS disease
BioMarin Pharmaceutical Inc. started a late-stage trial of an experimental drug to treat a rare autoimmune disease called Lambert-Eaton Myasthenic Syndrome, or LEMS.
The Phase III trial will test Novato-based BioMarin’s (NASDAQ: BMRN) amifampridine phosphate in about 30 patients across 25 sites worldwide, the company said.
The Phase III trial will test Novato-based BioMarin’s (NASDAQ: BMRN) amifampridine phosphate in about 30 patients across 25 sites worldwide, the company said.
Xoma hires Paul Rubin as CMO, shifts founder Patrick Scannon to CSO
Xoma Ltd. hired a new chief medical officer and said founder Dr. Patrick Scannon, who worked two years as chief medical officer, shifted to the job of chief scientific officer.
Dr. Paul Rubin, the new chief medical officer of Berkeley-based Xoma (NASDAQ: XOMA), had been in the same job at Funxional Therapeutics Ltd. He was senior vice president of development and later executive vice president of research and development at Sepracor, where he was responsible for development of all internally developed products, such as the sleep drug Lunesta.
Dr. Paul Rubin, the new chief medical officer of Berkeley-based Xoma (NASDAQ: XOMA), had been in the same job at Funxional Therapeutics Ltd. He was senior vice president of development and later executive vice president of research and development at Sepracor, where he was responsible for development of all internally developed products, such as the sleep drug Lunesta.
Stanford loses Roche HIV patent dispute
The U.S. Supreme Court on Monday threw out Stanford University's patent suit against a Roche Holding AG subsidiary involving an HIV diagnostic test, the Wall Street Journal reports.
The court voted 7-2 to uphold a lower-court decision that a Stanford scientist transferred discovery rights to Cetus Corp., in exchange for information and facilities from the company.
Those rights were eventually transferred to Roche.
The court voted 7-2 to uphold a lower-court decision that a Stanford scientist transferred discovery rights to Cetus Corp., in exchange for information and facilities from the company.
Those rights were eventually transferred to Roche.
Biotech startup Cyterix raises $9.2M Series A
Biotech startup Cyterix Pharmaceuticals Inc. raised $9.2 million from The Column Group and SV Life Sciences in a Series A financing.
The San Francisco company, founded by academics Steve Everett and Paul Ortiz de Montellano and the late biotech entrepreneur John Curd, is working to discover and develop drugs that target certain enzymes that are highly over-expressed in many cancers. Specifically, it targets extra-hepatic cytochrome P450 enzymes.
The San Francisco company, founded by academics Steve Everett and Paul Ortiz de Montellano and the late biotech entrepreneur John Curd, is working to discover and develop drugs that target certain enzymes that are highly over-expressed in many cancers. Specifically, it targets extra-hepatic cytochrome P450 enzymes.
Monday, June 6, 2011
Exelixis prostate cancer drug wows researchers, not Wall Street
While a melanoma-fighting drug from Roche and Berkeley’s Plexxikon Inc. seemed to steal the American Society of Clinical Oncology show this weekend, it was Exelixis Inc.’s prostate cancer treatment that made headlines Monday.
Not for all the right reasons, though.
Not for all the right reasons, though.
Burrill hires merchant banking CEO
Burrill & Co., a finance business for life science companies, hired Stephen Hurly as CEO of its merchant banking operation.
Hurly takes a job that has been vacant for several months since Shawn Cross left for a healthcare investment banking job at Wells Fargo.
Hurly takes a job that has been vacant for several months since Shawn Cross left for a healthcare investment banking job at Wells Fargo.
Impax receives FDA warning letter for Hayward plant
Generic drug maker Impax Laboratories Inc. received a warning letter from the FDA regarding sampling and testing of drugs at its Hayward plant.
Impax (NASDAQ: IPXL), which also has its headquarters and research and development in Hayward, said it was cited by the Food and Drug Administration for sampling and testing of materials and drug products, production record review and the company’s process for inspecting the failure of some manufacturing batches to meet specifications.
Impax (NASDAQ: IPXL), which also has its headquarters and research and development in Hayward, said it was cited by the Food and Drug Administration for sampling and testing of materials and drug products, production record review and the company’s process for inspecting the failure of some manufacturing batches to meet specifications.
Impax spending $52M to expand Taiwan plant
Pushed to the limit at its manufacturing plants and eyeing production of a Parkinson’s disease drug for GlaxoSmithKline, Impax Laboratories Inc. is undertaking a $52 million expansion of its year-old Taiwan facility.
Hayward-based Impax (NASDAQ: IPXL) said it would expand the 100,000-square-foot plant in Chunan, Taiwan, so it could produce up to 700 million tablets or capsules a year. An Impax spokesman did not say how large the expansion would be, but he said the plant currently can make as many as 450 million drugs a year.
The expansion, the first phase of a plan to increase the plant’s capacity to 1.5 billion tablets or capsules a year, should be completed by the end of 2012.
Hayward-based Impax (NASDAQ: IPXL) said it would expand the 100,000-square-foot plant in Chunan, Taiwan, so it could produce up to 700 million tablets or capsules a year. An Impax spokesman did not say how large the expansion would be, but he said the plant currently can make as many as 450 million drugs a year.
The expansion, the first phase of a plan to increase the plant’s capacity to 1.5 billion tablets or capsules a year, should be completed by the end of 2012.
Friday, June 3, 2011
Hansen Medical names Peter Mariani CEO
Hansen Medical Inc. on Friday named Peter J. Mariani chief financial officer.
Mountain View-based Hansen (NASDAQ:HNSN) said Mariani replaces Peter Osborne, who has been interim CFO since February 2010.
Mountain View-based Hansen (NASDAQ:HNSN) said Mariani replaces Peter Osborne, who has been interim CFO since February 2010.
Novartis growth could fill Emeryville hole
Bayer’s decision to pull out of Emeryville leaves a mark — first and foremost on the 540 jobs that will be lost over the next two years when the pharmaceutical company outsources production of its multiple sclerosis drug Betaseron.
And while Novartis isn’t ready to shed any light on its plans for the building, it’s providing a possible clue down the block. Novartis is soon to begin demolishing the five-story former lab building, known as Building M.
And while Novartis isn’t ready to shed any light on its plans for the building, it’s providing a possible clue down the block. Novartis is soon to begin demolishing the five-story former lab building, known as Building M.
Anthera Pharma aims to raise $47M in stock offering
Anthera Pharmaceuticals Inc. hopes to net $47 million by selling more than 6.6 million shares at $7.50 each.
The Hayward developer of cardiovascular and autoimmune disease drugs (NASDAQ: ANTH) said the offering is expected to close next week. The final figure could swell to $54 million if underwriters exercise an over-allotment option.
The Hayward developer of cardiovascular and autoimmune disease drugs (NASDAQ: ANTH) said the offering is expected to close next week. The final figure could swell to $54 million if underwriters exercise an over-allotment option.
Taiwan lands $30M commitment from Burrill, promise from Impax
When Christina Liu, minister of Taiwan’s Council for Economic Planning & Development, came through the Bay Area on a whirlwind U.S. tour last month, it was anything but a getting-to-know-you session.
San Francisco life sciences merchant bank Burrill & Co. agreed to invest $30 million, according to Taipei Times. Likewise, Hayward-based Impax Laboratories Inc., which has a production facility in Chunan Science Park, promised further investments, the newspaper said.
San Francisco life sciences merchant bank Burrill & Co. agreed to invest $30 million, according to Taipei Times. Likewise, Hayward-based Impax Laboratories Inc., which has a production facility in Chunan Science Park, promised further investments, the newspaper said.
Biotechs aim to extend popular grant, tax credit program
Biotechs are going hat in hand to Washington, again, hoping to extend a popular tax credit and grant program by as much as $5 billion over five years.
Whether the call for help is heard by a Congress focused on trimming the federal budget at all costs is another matter, but industry leaders say biotech and medical device companies are as much in peril as they were when the original program kicked in last year.
Whether the call for help is heard by a Congress focused on trimming the federal budget at all costs is another matter, but industry leaders say biotech and medical device companies are as much in peril as they were when the original program kicked in last year.
VCs look to LLCs to reap benefit of biotech investments
Biotech startups are finding innovation in unexpected places: their attorneys and accountants.
As the market for IPOs and mergers and acquisitions has narrowed, a growing number of startups are forming under “limited liability company” umbrellas as a way to distribute income to investors more quickly than through traditional C corporation structures. In the process, the LLC structure limits investors’ tax liabilities.
As the market for IPOs and mergers and acquisitions has narrowed, a growing number of startups are forming under “limited liability company” umbrellas as a way to distribute income to investors more quickly than through traditional C corporation structures. In the process, the LLC structure limits investors’ tax liabilities.
Tech, history could hold answer to cancer treatment
Clinical trials are a key part of medical research, but only about 3 percent of U.S. cancer patients volunteer for such studies. Dr. Peter Paul Yu wants to learn from the remaining 97 percent.
Yu is director of cancer research at the Palo Alto Medical Foundation, where he also has a clinical practice. The organization is large — more than 900 physicians serving 700,000 patients in the Bay Area. Being in the heart of Silicon Valley, it has long had a great information technology system, he said. That makes for a great database on diagnoses, treatment and results.
Yu is director of cancer research at the Palo Alto Medical Foundation, where he also has a clinical practice. The organization is large — more than 900 physicians serving 700,000 patients in the Bay Area. Being in the heart of Silicon Valley, it has long had a great information technology system, he said. That makes for a great database on diagnoses, treatment and results.
Accuray CEO Euan Thomson battles cancer from hospital to business world
It’s sometimes said that you can judge a man by the quality of his enemies. Accuray Inc. CEO Euan Thomson’s enemy is cancer.
Thomson has battled cancer his entire career, first in the clinical world as a medical physicist in hospitals, and later in business as a consultant and executive at companies doing cancer research. Joining Accuray in 2002, he helped build it into a unique, $221 million medical device company with a focus on developing answers to problems cancer doctors actually have, said Chris Raanes, chief operating officer of Accuray.
Thomson has battled cancer his entire career, first in the clinical world as a medical physicist in hospitals, and later in business as a consultant and executive at companies doing cancer research. Joining Accuray in 2002, he helped build it into a unique, $221 million medical device company with a focus on developing answers to problems cancer doctors actually have, said Chris Raanes, chief operating officer of Accuray.
AcelRx Army grant validates technology - CEO
AcelRx Pharmaceuticals Inc. has received a $5.6 million grant from the U.S. Army Medical Research and Material Command to fund its Phase 2 clinical trials for a new drug that has the potential to help wounded soldiers in the battlefield.
Its product, ARX-04, is a nanotablet dispensed under the tongue for non-invasive, rapid treatment of moderate to severe acute pain. The product also has uses for the general public to treat trauma or injury such as post-operative pain from knee replacement surgery.
Its product, ARX-04, is a nanotablet dispensed under the tongue for non-invasive, rapid treatment of moderate to severe acute pain. The product also has uses for the general public to treat trauma or injury such as post-operative pain from knee replacement surgery.
Phil Berman's search for an AIDS vaccine
In 2009, the news shocked the biotech industry — research had produced an immunization that was 31 percent effective against HIV, the first time an AIDS vaccine had ever shown significant results.
Yet the surprise of the announcement belied the amount of work that went into it. Dr. Phil Berman had been quietly working to advance this research — at large biotech firms, at small startups, at nonprofits, and finally as professor at the University of California, Santa Cruz — for 27 years.
“I was in Oxford when it was announced, wide awake, jet lagged, in the middle of the night. And BBC News came on and the headline news was this combination of vaccines,” said Mark Akeson, chair of the biomolecular engineering department at UCSC. “I knew immediately that one of them was his. It was an astonishing moment.”
Yet the surprise of the announcement belied the amount of work that went into it. Dr. Phil Berman had been quietly working to advance this research — at large biotech firms, at small startups, at nonprofits, and finally as professor at the University of California, Santa Cruz — for 27 years.
“I was in Oxford when it was announced, wide awake, jet lagged, in the middle of the night. And BBC News came on and the headline news was this combination of vaccines,” said Mark Akeson, chair of the biomolecular engineering department at UCSC. “I knew immediately that one of them was his. It was an astonishing moment.”
Shell transfers stake in biofuels company Codexis to Raizen
Royal Dutch Shell has sold its 15.7 percent stake in Codexis to Raizen Energia Participacoes S.A., the $12 billion biofuels joint venture Shell has with Cosan Limited.
Raizen is now Codexis' largest shareholder and can appoint a member to the Codexis board of directors.
Codexis, based in Redwood City, produces enzymes that break down renewable materials or sugars and convert them into fuels.
Raizen is now Codexis' largest shareholder and can appoint a member to the Codexis board of directors.
Codexis, based in Redwood City, produces enzymes that break down renewable materials or sugars and convert them into fuels.
Thursday, June 2, 2011
Former Aetna CEO gives $1M to Buck Institute for Age Research
The former chairman and CEO of health insurer Aetna Inc. donated $1 million to the Buck Institute for Age Research.
John “Jack” Rowe, who led a panel that in 1985 recommended creating the institute to bring together a range of scientists to focus on age research, made the gift with his wife, Valerie.
John “Jack” Rowe, who led a panel that in 1985 recommended creating the institute to bring together a range of scientists to focus on age research, made the gift with his wife, Valerie.
ASCO showcasing Bay Area cancer therapies
The cancer drug world will focus on Chicago at this weekend’s American Society of Clinical Oncology meeting.
As I reported in last week’s print edition, this opportunity to report data from recent studies is a make-or-break meeting for many drug developers. It’s a chance to hook up with potential clinicians, investors and partners.
Here is a quick look at what some Bay Area companies are showcasing at ASCO.
As I reported in last week’s print edition, this opportunity to report data from recent studies is a make-or-break meeting for many drug developers. It’s a chance to hook up with potential clinicians, investors and partners.
Here is a quick look at what some Bay Area companies are showcasing at ASCO.
Poniard asks shareholders to OK big reverse stock split
Cancer drug developer Poniard Pharmaceuticals Inc., which is studying a possible sale, will ask shareholders to give its board authority for a reverse stock split between 1-for-15 and 1-for-25 shares.
If the proposal is not passed, San Francisco-based Poniard (NASDAQ: PARD) has warned shareholders, the company could be delisted from the NASDAQ exchange.
If the proposal is not passed, San Francisco-based Poniard (NASDAQ: PARD) has warned shareholders, the company could be delisted from the NASDAQ exchange.
Durect CMO Joseph Stauffer resigns
Durect Corp. said Thursday that its chief medical officer and executive vice president of corporate strategy, Dr. Joseph Stauffer, has resigned.
The Cupertino company said Stauffer will pursue other opportunities, but did elaborate.
Stuaffer and Durect (NASDAQ:DRRX) have entered into a consulting agreement through the end of the year.
The Cupertino company said Stauffer will pursue other opportunities, but did elaborate.
Stuaffer and Durect (NASDAQ:DRRX) have entered into a consulting agreement through the end of the year.
NovoStent names Rick Randall chairman
NovoStent Corp. on Thursday named Rick Randall chairman of the board.
Randall is currently CEO and chairman of Avantis Medical Systems Inc. and chairman of TranS1 Inc.
Randall is currently CEO and chairman of Avantis Medical Systems Inc. and chairman of TranS1 Inc.
Posit Science changes CEOs, named Henry Mahncke chief executive
Posit Science, the San Francisco-based maker of brain training software, has named research scientist Henry Mahncke as its new CEO. Mahncke’s promotion took place in late March, but was disclosed Thursday.
He replaces Steven Aldrich, who left the company after two years at the helm “to pursue other interests.”
He replaces Steven Aldrich, who left the company after two years at the helm “to pursue other interests.”
Wednesday, June 1, 2011
One-on-one with ExploraMed and NeoTract founder Josh Makower
Josh Makower is more than a voice calling for change in the way the Food and Drug Administration deals with the medical device industry; he’s a consulting associate professor at Stanford University Medical School, a venture partner with New Enterprise Associates, founder of the ExploraMed medical device incubator in Mountain View and an entrepreneur.
Makower talks to San Francisco Business Times biotech reporter Ron Leuty about ExploraMed graduate NeoTract Inc., a Pleasanton-based company that hopes to bring its device finally to the United States.
Makower talks to San Francisco Business Times biotech reporter Ron Leuty about ExploraMed graduate NeoTract Inc., a Pleasanton-based company that hopes to bring its device finally to the United States.
Law firm Foley & Lardner launches $4 million VC fund
Law firm Foley & Lardner LLP announced Wednesday that it launched a $4 million venture capital fund exclusively for its clients.
The firm, which has an office on Page Mill Road in Palo Alto, said Foley Ventures would be used to "invest in or with" its clients.
The firm, which has an office on Page Mill Road in Palo Alto, said Foley Ventures would be used to "invest in or with" its clients.
Affymetrix CEO steps down, replaced by former Dionex CEO
Affymetrix Inc. on Wednesday named Frank Witney president and CEO.
Santa Clara-based Affymetrix (NASDAQ:AFFX) said Witney has 30 years of experience in the life science research products and diagnostic and analytical instrument industry and worked in senior leadership positions at Dionex, Panomics, Affymetrix and Bio-Rad.
Witney, who will also join the company’s board of directors, succeeds Kevin M. King who has resigned as Affymetrix’s president and chief executive officer to pursue other interests.
Santa Clara-based Affymetrix (NASDAQ:AFFX) said Witney has 30 years of experience in the life science research products and diagnostic and analytical instrument industry and worked in senior leadership positions at Dionex, Panomics, Affymetrix and Bio-Rad.
Witney, who will also join the company’s board of directors, succeeds Kevin M. King who has resigned as Affymetrix’s president and chief executive officer to pursue other interests.
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