Genentech's Avastin back in front of FDA for breast cancer decision

SF's Mission Bay coming of age

California controller: Suspend process of selecting chair of stem cell agency

Out of stealth, Sequenta grabs $13M

Faster, cheaper and finer DNA sequencing — and a big investment from some well-known venture capital and angel investment names — is positioning an early-stage molecular diagnostics company in San Francisco’s Mission Bay to offer a test providing a much earlier peek at immune system problems.

StemCells wins OK for spinal cord trial

A Swiss researcher will lead a Phase I/II trial using neural stem cells from Palo Alto's StemCells Inc. to repair spinal cord injuries that are less than a year old.

Life sciences chip developer Fluidigm files for $86M IPO

Fluidigm Corp., a South San Francisco company that makes microfluidic systems for the life science and agricultural biotech markets, filed paperwork late Friday for an $86.25 million initial public offering.

Klein tabbed by Schwarzenegger to lead CIRM, again

Gov. Arnold Schwarzenegger nominated Robert Klein to lead California's stem cell research funding agency for another six-year term.
The nomination is the latest chapter in an ongoing saga revolving around the lay leadership of the California Institute for Regenerative Medicine, a semi-independent agency that could award as much as $3 billion for stem cell research.
Schwarzenegger is one of four executive officers of the state — along with Lt. Gov. Abel Maldonado, Treasurer Bill Lockyer and Controller John Chiang — to nominate candidates for the chair position. A decision could be made by the board at its Dec. 15 meeting at Stanford University.

GE, UCSF technology IDs aggressive tumors

Technology developed out of a partnership between the University of California, San Francisco, and GE Healthcare is giving prostate cancer patients a real-time look into the aggressiveness of their tumors, potentially changing the course of treatment and lowering health care costs.
The technology, now in an early-stage trial at UCSF's Mission Bay campus, could reduce the time it takes to diagnose prostate cancer and prevent some of the roughly 200,000 men diagnosed each year with the disease from undergoing surgery that may not be necessary.

Report: Stem cell agency chair candidate withdraws

A handpicked candidate to head California stem cell research funding agency has reportedly withdrawn from consideration.
Alan Bernstein, who outgoing California Institute for Regenerative Medicine chair Robert Klein was pushing to lead the agency as executive chairman, withdrew his nomination, according to the California Stem Cell Report blog.
Klein would not confirm that Bernstein had withdrawn. “That’s possible,” he said, adding that he was waiting for a call from Gov. Arnold Schwarzenegger's office regarding the governor’s nomination for chair.

Hana Biosciences digs in to new Talon name

What’s in a name? For the newly dubbed Talon Therapeutics Inc., it’s all about the independent claws.

CIRM leaders push Canadian for chairman post

Backroom politics could vault a relatively unknown and unqualified nominee to the top of the list to head California’s $3 billion stem cell research funding agency, according to a longtime member of the board overseeing the California Institute for Regenerative Medicine.

Pearl Therapeutics COPD drug passes test

A mid-stage trial of Pearl Therapeutics Inc.’s combination therapy to treat chronic obstructive pulmonary disease is helping the company and COPD patients breathe easier.

Neuraltus ALS drug results 'encouraging'

An experimental drug from Neuraltus Pharmaceuticals Inc. was effective against a biomarker of amyotrophic lateral sclerosis, or Lou Gehrig’s disease, in an early-stage study.
Although the clinical study by the privately held, Palo Alto-based company was only Phase I, involved just 32 people and assessed the drug’s effect on the biomarker only 24 hours after dosing, the result is significant because Neuraltus’ drug is believed to be the first to provide a statistically significantly improvement in blood levels of the biomarker.
The finding also could garner more attention for Neuraltus — particularly from investors — as it tries to raise money to undertake a more extensive Phase II study.

Stem cell agency, BioTime strike deal

BioTime Inc. will make five clinical-grade human embryonic stem cell lines available to California researchers, according to a deal between the Alameda company and California’s stem cell research funding agency, that could smooth the translation of stem cell science into actual therapies.

Sorry for the disapperance …

Google shut me down. Apparently, its computer thought this blog was spam.

I do not like spam, and spam I am not.

After a couple of months, I finally noticed the appeal button, and within a couple of days Google restored the blog. I will try keeping up this site and my alternate site (specifically with San Francisco Bay Area links) at http://biotech-day.blogspot.com/.

And if that isn't confusing, I don't know what is.

By the way, you can follow me on Twitter at http://twitter.com/rleuty_biotech.

Talecris shares rise as profit tops Street

Shares of Talecris Biotherapeutics rose more than 6 percent in after hours trading Wednesday after the company released first quarter results that beat analyst estimates.

Titan Pharmaceuticals to sell 9.7M shares

Titan Pharmaceuticals Inc. hopes to resell 9.7 million shares — an estimated $16.8 million in common stock — for a group of shareholders.
The South San Francisco company (OTC: TTNP.PK), which developed a Food and Drug Administration-approved treatment for schizophrenia and is working on a late-stage implantable device for delivering the opioid addiction drug buprenorphine, said it would not receive the proceeds of the stock sale. It could, however, receive up to $12.4 million from the exercise of warrants.

Cardiac Science loses $8.6M in Q1

Cardiac Science Corp., which Tuesday was warned by the U.S. Food and Drug Administration that 280,000 of its external defibrillators may not work to rescue people suffering sudden cardiac arrest, reported a first quarter loss of $8.6 million, or a loss of 36 cents per share.

KV Pharmaceutical keeps Ethex CEO as consultant

Michael Anderson is resigning his job Friday as head of KV Pharmaceutical’s closing generics subsidiary but he won’t be out of work.
The drug maker has hired Anderson, the president and chief executive of its Ethex Corp. as a consultant for a year and agreed to pay him his annual base salary of $344,300 for 25 hours a week of work or less.

Midmark partners on new heart products

Midmark Corp. has partnered with Mortara Instrument on a new product line of electrocardiogram products.

BioCryst narrows 1Q net loss to $2.6M

BioCryst Pharmaceuticals Inc. cut its first quarter 2010 net losses by 72 percent from the same period in 2009 thanks in part to a 600 percent increase in total revenues.

Xlumena device gets FDA approval

Xlumena Inc. on Wednesday said it received clearance from the U.S. Food and Drug Administration for its advanced endoscopy device.

FDA delays approval of Salix drug

Salix Pharmaceuticals will have to wait a little longer before it can start selling a stronger version of its ulcerative colitis drug Colazal.
The Morrisville, N.C., company said Wednesday that it had received a complete response letter from the U.S. Food and Drug Administration regarding Salix’s New Drug Application for Giazo, which is the same drug as Colazal but delivered at a higher dose.

AVI BioPharma gets $4M more from U.S. Defense Dept.

AVI BioPharma Inc. said it’s receiving another $4 million from the U.S. government to develop drugs targeting swine flu.

Austin biopharmaceutical company wins $913K grant

Selenium Ltd. was awarded a two-year, $912,943 grant from The National Institute of Dental and Craniofacial Research, officials announced Wednesday.

Moffitt Cancer Center gets $2.8 million grant for Project Quit Read more: Moffitt Cancer Center gets $2.8 million grant for Project Quit - Tampa Bay Business Journal:

The H. Lee Moffitt Cancer Center & Research Institute received a $2.8 million research grant from the National Cancer Institute to test the effectiveness of smoking cessation booklets.

FDA approves Teva’s generic for Flomax

The Food and Drug Administration granted marketing approval Wednesday to Teva Pharmaceutical Industries for a generic version of Flomax, a drug used to treat enlarged prostate.

Discovery Laboratories gives report on Surfaxin progress

Discovery Laboratories Inc. said Wednesday it is continuing to make progress on addressing the sole remaining issue needed to gain potential Food and Drug Administration approval next year for Surfaxin.
The drug is the biopharmaceutical’s company’s experimental treatment for respiratory distress syndrome in premature infants.

CEO Witty pleased as GlaxoSmithKline grows 1Q profit, revenue

GlaxoSmithKline, the British pharmaceutical giant with North American headquarters in Research Triangle Park, N.C., posted a higher profit Wednesday, driven by higher drug sales in non-U.S. markets.
GSK reported profit after taxation of almost $1.4 billion pounds, or nearly $2.2 billion. That’s up from first quarter 2009 profit of 1.17 billion pounds.

Delta raises $1M for breast cancer research

Delta Air Lines Inc. customers and employees raised $1 million for The Breast Cancer Research Foundation in 2009.

Michael J. Fox Foundation backs Amarantus

Amarantus Therapeutics Inc. said Wednesday it received a research grant from The Michael J. Fox Foundation for Parkinson's Research.
Sunnyvale, Calif.-based Amarantus Therapeutics will use the funding to study the efficacy of mesencephalic astrocyte-derived neurotrophic factor (MANF), a highly potent, neurotrophic factor currently in pre-clinical development for the treatment of Parkinson's disease.

FDA approves Asthmatx asthma device

Asthmatx Inc. said Wednesday the U.S. Food and Drug Administration has approved its Alair Bronchial Thermoplasty System for the treatment of severe persistent asthma.

TomoTherapy sees sales rise, losses drop

TomoTherapy Inc., the Madison developer and marketer of a targeted radiation cancer therapy system, said revenue for the first quarter increased 37 percent and that its net loss for the period dropped 64 percent.

Jennerex adds Affymax executive to board

Cancer treatment company Jennerex Inc. put Paul Cleveland on its board of directors.
Jennerex, based in San Francisco and Ottawa, plans a Phase III test of a liver cancer treatment later this year.

Synergetics, Alcon ink $32M licensing deal, settle suit Read more: Synergetics, Alcon ink $32M licensing deal, settle suit - St. Louis Business Journal:

Synergetics USA Inc. has struck a $32 million deal giving Alcon Laboratories Inc. the right to sell Synergetics products.
The agreement also settles all litigation between Synergetics and Alcon.

Lycera gets $11M tranche

Lycera Corp. of Cambridge has received an $11 million second tranche of its Series A round, the company announced.

Gilead: HIV combo drug set for FDA review

Data from a study of a potential once-a-day HIV medication — a combination of Gilead Sciences Inc.’s Truvada and an experimental drug from Johnson & Johnson-owned Tibotec Pharmaceuticals — showed that the drugs can work together, Gilead said.
Foster City-based Gilead (NASDAQ: GILD) could submit its application for the combined once-a-day, fixed-dose pill to the Food and Drug Administration within months, after the FDA agrees to review Tibotec’s own new drug application.

Seattle Genetics reports Q1 net income of $11.5M

Seattle Genetics Inc. reported first-quarter net income of $11.5 million, or earnings of 11 cents per share, which compares with a loss of $27.3 million, or a loss of 33 cents a share a year earlier.

FDA warns of Cardiac Science defibrillators; shares dive

The U.S. Food and Drug Administration warned that 280,000 external defibrillators made by Cardiac Science Corp. may not work to rescue people suffering sudden cardiac arrest.

Judge rejects $296M plea deal by Boston Scientific unit

A federal judge in Minneapolis has rejected a $296 million plea deal to settle criminal charges against Boston Scientific Corp.'s Guidant division over claims that the company failed to report possible defibrillator defects.