Biotech Day: Tuesday's national biotech news

From the 40 business journals of American City Business Journals …

Biogen to fund mapping of ALS genome (Boston Business Journal)
Biogen Idec (NASDAQ: BIIB) has entered into a research collaboration with Duke University and the HudsonAlpha Institute for Biotechnology designed to sequence the genomes of up to 1,000 patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The goal is to gain a better understanding of the genetic causes of ALS, in order to come up with better potential treatments.

Navigenics' Vance Vanier.

Life Technologies buys DNA test developer Navigenics (San Francisco Business Times)

Life Technologies Corp. bought genetic-information company Navigenics Inc., the company said Monday, giving the testing equipment giant an inroad to process lab tests for doctors. Carlsbad-based Life Technologies (NASDAQ: LIFE) did not disclose the value of the deal, but it said it is its "first step" toward building out its molecular diagnostics business through internal development, partnerships and select acquisitions. Foster City-based Navigenics, run by San Francisco Business Times 40 Under 40 award winner Vance Vanier, develops DNA tests that tell doctors if patients have genetic markers for certain diseases. It is one of a handful of companies that have taken advantage of faster, more accurate systems, like those offered by Life Technologies, to tap into consumers' interest in predicting and preventing diseases.


NuPathe resubmits migraine patch to FDA (Philadelphia Business Journal)

NuPathe is ready to take another shot at getting its migraine patch Zelrix approved. The company (NASDAQ:PATH) said it has resubmitted the treatment to the Food and Drug Administration. Last year the FDA raised chemistry, manufacturing and safety questions about the product.

Johnson & Johnson firm seeking new use for Simponi (Philadelphia Business Journal)
Janssen Biotech and Janssen Biologics are requesting Food and Drug Administration and European Medicines Agency approval to make their Simponi drug a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy."



A watershed moment in the fight against HIV (Boston Business Journal)

I caught my breath as I opened an email from the FDA Monday. The agency had for the first time approved a drug to prevent the spread of HIV, made by California biotech Gilead Sciences Inc (Nasdaq: GILD). This day is a day that has been the dream of patients, family members, activists, and medical providers throughout my entire adult life.

Related story: FDA approves Gilead's Truvada as first pill for HIV prevention (San Francisco Business Times)

Human Genome Sciences CEO Tom Watkins

Unknown future for Human Genome Sciences, execs after GlaxoSmithKline buyout (Washington Business Journal)

British pharmaceutical company GlaxoSmithKline PLC (NYSE: GSK) is snapping up Rockville-based Human Genome Sciences Inc. (Nasdaq: HGSI) for $3.6 billion, raising a host of questions over the local biotech’s future along the Interstate 270 corridor. It’s yet unclear how Glaxo plans to reshape its longtime partner, whether it will keep management in place or clean house — as in other recent big pharma acquisitions — and whether it will maintain Human Genome Sciences’ Maryland facilities.

MedImmune will open new center, shift 40 jobs to Hayward (San Francisco Business Times)

The South Bay's loss of MedImmune will be the East Bay's gain. The vaccine and infectious diseases drug developer said it plans to open a new translational sciences area for applied immunology and microbiology in Hayward as it closes facilities in Mountain View and Santa Clara.

Related story: MedImmune closures in Mountain View, Santa Clara will ax hundreds of jobs (San Francisco Business Times)

Moody's downgrades Thermo Fisher on Lamba acquisition (Boston Business Journal)

Moody’s Investors Service announced it would downgrade $6.6 billion of Thermo Fisher Scientific’s (NYSE: TMO) debt, just hours after the life sciences tools company said it would acquire California diagnostics firm One Lambda for $925 million in cash. Moody’s lowered the credit rating for Waltham, Mass.-based Thermo Fisher one notch to Baa1 from A3. The outlook is stable, Moody’s said.

Med-tech devices may get barcodes (Minneapolis-St. Paul Business Journal)

How do you place a unique identifying number on a medical device? That’s a question many med-tech companies will be considering in the coming years, thanks to proposed guidelines issued last week by the Food and Drug Administration. The FDA wants medical-device companies to use barcodes or other techniques to label each of their products. The program’s goal is to make it easier for the agency to determine whether particular devices are malfunctioning or otherwise harming patients. The FDA estimates the effort will cost the medical-device industry about $68.4 million a year.

Repros Therapeutics files protocol for mid-stage study of drug on clinical hold (Houston Business Journal)

Repros Therapeutics Inc. (Nasdaq: RPRX) said Monday it plans to submit to the Food and Drug Administratio  protocol for a phase 2 study of Proellex. Proellex is an oral drug intended to treat endometriosis and uterine fibroids. The FDA said it would change the drug’s full clinical hold to a partial clinical hold once the phase 2 protocol is approved.

Life Technologies buys DNA test developer Navigenics

Life Technologies Corp. bought genetic-information company Navigenics Inc., the company said Monday, giving the testing equipment giant an inroad to process lab tests for doctors.

Carlsbad-based Life Technologies (NASDAQ: LIFE) did not disclose the value of the deal, but it said it is its "first step" toward building out its molecular diagnostics business through internal development, partnerships and select acquisitions.

Foster City-based Navigenics, run by San Francisco Business Times 40 Under 40 award winner Vance Vanier, develops DNA tests that tell doctors if patients have genetic markers for certain diseases. It is one of a handful of companies that have taken advantage of faster, more accurate systems, like those offered by Life Technologies, to tap into consumers' interest in predicting and preventing diseases.

Lab worker shortage threatens hot molecular diagnostics industry

A tug-of-war for hiring specialized, hard-to-find lab workers could pull a potential growth industry out of California.
Molecular diagnostic test companies — part of the personalized medicine boom — are competing with hospitals and reference labs for master’s degree-level clinical laboratory scientists, or CLSs. That conflict is driving wages higher, company leaders say, as underfunded job-training programs can’t keep up with demand.
But leaders in the life sciences industry and academia will launch a program in September that could alleviate the supply-demand crush. Tapping federal economic stimulus program cash, the program will narrow the scope of CLS training for molecular diagnostics companies, helping them land the workers they need to quickly send test results back to doctors and patients.
At the same time, the new program could allow hospitals to hold onto more broadly trained lab workers.

'Great march of human progress' aims to predict, prevent, treat disease at individual level

Some day — perhaps in the next year or two — you’ll be able to spit on your microfluidic chip-embedded Blackberry, which will analyze the sample and instantly diagnose your illness, said life sciences merchant banker Steve Burrill.
So-called personalized medicine will allow people to discover — more quickly and more accurately — what’s ailing them and at a lower cost, Burrill said, and that includes everything from real-time diagnostics and prevention to individualized cancer vaccines.
Personalized medicine already has given rise to companies like cancer diagnostics firm Genomic Health Inc. of Redwood City and up-and-coming stars like diabetes diagnostics company Tethys Bioscience Inc. in Emeryville, cardiovascular diagnostics firm CardioDx Inc. of Palo Alto and Foster City genetic testing company Navigenics Inc.