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FDA says Zimmer's recalled tool could be deadly - FierceMedicalDevices

FDA says Zimmer's recalled tool could be deadly - FierceMedicalDevices | Austin Life Sciences and Healthcare Updates | Scoop.it
Last week, Zimmer launched a worldwide recall of its PEEK Ardis spinal surgery tool, and now the FDA has slapped a Class I tag on the effort, warning that use of the device could result in serious injury or death.
Nishi Viswanathan's insight:

This announcement comes close on the heels of Zimmer's recall- http://www.fiercemedicaldevices.com/story/zimmer-pursues-global-recall-spinal-surgical-instrument/2012-12-20

 

 

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Austin Life Sciences and Healthcare Updates
Business insights and tips for the Life Sciences sector- including Bioetechnology, Healthcare, Pharma
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Crowdfunding For Life Sciences Companies: To Seek Or Not To Seek

Crowdfunding For Life Sciences Companies: To Seek Or Not To Seek | Austin Life Sciences and Healthcare Updates | Scoop.it
Crowdfunding For Life Sciences Companies: To Seek Or Not To Seek
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A quick crowdfunding primer for life sciences companies looking at creative options. Also check out the comment from Medstartr, one of the portals in this space. 

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Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer's Disease

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer's Disease | Austin Life Sciences and Healthcare Updates | Scoop.it

Luminex has signed a collaboration and license agreement with Merck to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck's clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead investigational candidate for Alzheimer's disease (AD).

 

 

Nishi Viswanathan's insight:

Companion diagnostics is one of the fastest growing fields in biotech today. Personalized medicine may have sounded like science fiction a decade ago, but with advances in companion diagnostics and genetic sequencing, we are getting there. 

 

"Evaluation of biomarkers that may provide an indicator of disease onset and enable earlier diagnosis is an important goal toward facilitating early intervention and potentially improving the treatment of Alzheimer's disease," said Darryle D. Schoepp, Ph.D., senior vice president, head of Neuroscience and Ophthalmology at Merck Research Laboratories. "We look forward to working with Luminex to advance our ongoing clinical development program for MK-8931."

 

It might seem counterintuitive to some that companies would be OK with excluding certain populations from taking their drugs by screening for biomarkers. But the revenue lost from narrowing a drug's target may not be a bad thing, considering companies can make more revenue from fewer customers by helping avoid adverse effects (and consequent recalls and lawsuits) and by selling companion diagnostics as monitoring tests.

 

About Luminex: The company develops, manufactures and markets proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time PCR, and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex serves customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety.

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Biotech company expands to Austin for efficiency, workforce

Biotech company expands to Austin for efficiency, workforce | Austin Life Sciences and Healthcare Updates | Scoop.it

Veracyte, a California-based biotech company is opening an office and lab facility in Austin according to an exclusive from Austin Business Journal. 

Nishi Viswanathan's insight:

Veracyte develops diagnostic products that enable doctors to make better and more efficient treatment decisions primarily in the areas of lung and thyroid cancer.


The California-based company that employs around 90 workers at its San Francisco headquarters, plans to set up an office and lab facility in Austin. According to sources, the company has leased 10,000 sq.ft at an undisclosed location in Austin. Operations at this facility expected to begin by the second quarter of this year. 


The main reasons stated for the move- the central location of Austin and the high quality workforce. Austin's reputation as a creative hotbed and proximity to a high class university amped its chances when Veracyte executives were looking for opportunities for expansion. 

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GE is the latest Fortune 500 to form a startup accelerator, claiming a stake in 10 promising young companies

GE is the latest Fortune 500 to form a startup accelerator, claiming a stake in 10 promising young companies | Austin Life Sciences and Healthcare Updates | Scoop.it

GE is building on its commitment to innovation by partnering with StartUp Health to mentor and support young consumer health startups over the next three years. 

Nishi Viswanathan's insight:

Healthyimagination, a $6 billion commitment to make healthcare more affordable and accessible around the globe will begin in April in partnership with StartUp Health.


GE's accelerator program requires a three-year commitment from consumer health startups, and it doesn't necessarily involve an investment by GE. Startups will receive mentoring and guidance in return for a  2-10 percent equity stake in each company. Startups don't have to move for the program—they must report to quarterly Healthcare Transformer Summits in New York, San Francisco or Washington D.C. FAQ here: http://app.startuphealth.com/GE#.UPCOleT7JCg


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Austin’s economic engine should keep revving in 2013, experts say

Austin’s economic engine should keep revving in 2013, experts say | Austin Life Sciences and Healthcare Updates | Scoop.it

Austin will keep riding the tailwind it has enjoyed the past few years according to local economic experts.

Nishi Viswanathan's insight:

The growth is predicted to come from professional services, which includes many of Austin’s white collar and high-tech jobs, as well as the leisure and hospitality and the education and health services industries.

 

Venture Capital funding has been strong in 2012 and the trend is expected to continue into 2013. In addition to capital, Austin entrepreneurs will have more resources to tap into in 2013, thanks to an expanding collection of incubators and other accelerator programs. They include Capital Factory, which moved into new space downtown earlier this year and regularly hosts meetups and other gatherings aimed at bringing Austin’s startup community together. Others gearing up for 2013 include the Austin Technology Incubator, Tech Ranch Austin, Three Day Startup and a newly arrived accelerator program from Philadelphia called Dreamit Ventures.

 

Here is to a great year ahead!

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XBiotech Receives Fast Track Designation from FDA for True Human™ Monoclonal Antibody Therapy Targeting Inflammatory Cytokine IL-1a for Restenosis

XBiotech Receives Fast Track Designation from FDA for True Human™ Monoclonal Antibody Therapy Targeting Inflammatory Cytokine IL-1a for Restenosis | Austin Life Sciences and Healthcare Updates | Scoop.it
Nishi Viswanathan's insight:

Clinical results show that the therapeutic antibody blocks chronic inflammation in the blood vessel wall, which offers the potential to halt or even reverse the progression of atherosclerois and reduce the impact of heart attack and stroke, according to the company.

 

This is the second FDA Fast Track Designation secured by XBiotech for lead candidate, MABp1. The first FDA Fast Track Designation was received by the Company at the end of last year for Xilonix™ (MABp1) therapy for the treatment of advanced cancer with associated cachexia.

 

XBiotech pioneers breakthrough therapies that improve the safety and efficacy of antibody therapeutics. The Company’s lead product candidate inhibits chronic sterile inflammation by targeting IL-1α, a master regulator of inflammation. Earlier in 2012, the company announced it would expand its Austin footprint with a a six-building, $200 million biotech campus large enough to employ 2,000 people, including hundreds of highly paid doctors and scientists. 

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Tango Health collects $1M funding

Tango Health collects $1M funding | Austin Life Sciences and Healthcare Updates | Scoop.it
Austin software maker Tango Health Inc. has received a $1 million financing. The Austin-based company collected the capital from nine investors, according to a Thursday filing with the U.S. Securities and Exchange Commission.
Nishi Viswanathan's insight:

Tango Health helps reduce the total cost of health benefits for employers and employees by helping them manage their HSAs more efficiently. The company offers a turn-key HSA administration solution to employers and employees including a selection of top financial institutions as HSA custodians.

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Medical Device Excise Tax Seminar | Padgett Stratemann San Antonio & Austin

Medical Device Excise Tax Seminar | Padgett Stratemann San Antonio & Austin | Austin Life Sciences and Healthcare Updates | Scoop.it
Nishi Viswanathan's insight:

If you are a medical device professional, your company is likely concerned about the medical device excise tax which goes into effect January 1, 2013.  This lunch presentation will breakdown the law in easy to understand terms, educate attendees on the available exemptions and required documentation, and more...


Register by Jan 11, 2013. 

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Ortho Kinematics Raises $2 Million in New Funding | Business Wire

Ortho Kinematics Raises $2 Million in New Funding | Business Wire | Austin Life Sciences and Healthcare Updates | Scoop.it
Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today the close of
Nishi Viswanathan's insight:

Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced the close of more than $2 million in its Series B financing. 

 

The company's VMA (Vertebral Motion Analysis) technology platform captures video x-ray-type images of the spine, while patients are assisted through a series of flexion, extension, and lateral bending movements. 

 

Paul Gunnoe, recently appointed CEO of Ortho Kinematics, Inc., said, "We are excited about the strong interest being shown in the VMA by the investors, surgeons, payers, and other players in the spine category. With this Series B funding, OKI is well-positioned to advance its mission of revolutionizing the diagnostic side of the spine industry and becoming the new gold standard for spine motion assessments.” 

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Thermo Fisher Scientific : News Release

Thermo Fisher Scientific : News Release | Austin Life Sciences and Healthcare Updates | Scoop.it

Thermo Fisher expands its markets for lab products by acquiring Life Technologies for $13.6 billion.

Nishi Viswanathan's insight:

The deal gives Thermo a piece of the next generation sequencing pie via Life's marquee Ion Torrent sequencers. 


The combination aims to better serve research, specialty diagnostics and applied markets. Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific said “The acquisition of Life Technologies enhances all three elements of our growth strategy: technological innovation, a unique customer value proposition and expansion in emerging markets.


At this time, no plans are underway for any major changes at Life. Of course, the folks at Life and Thermo are no strangers to acquisitions so it is likely business as usual. Whether the deal leads to the expected $275 million in synergies in three years, only time will tell. 

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Shoutout to Glutact, one of the top five at Texas Venture Labs Investment Competition

Shoutout to Glutact, one of the top five at Texas Venture Labs Investment Competition | Austin Life Sciences and Healthcare Updates | Scoop.it

Glutact was one of the top five shortlisted companies at the TVL Investment Competition last week. The idea - Use tears to test Serum Glucose levels- sounds brilliant. A tip for the team here...

Nishi Viswanathan's insight:

First of all, congratulations to Glutact for being shortlisted at the competition. I love startups that are trying to solve real problems. If you read the SiliconHills piece (by following the link above), you will agree with me that this company looks like it has great potential. 

 

But I wish I could find more about them online. As soon as I heard about them, I googled their company name using several combinations of keywords "Glutact", "Glu Tact" and even "Glutact LinkedIn" but I did not find much besides the TVL mentions.

 

To the people at Glutact: You all are awesome! Please, Please take advantage of this publicity to set up a web presence asap. Investors and curious biotech aficionados like me might google you especially since you are in the limelight now. I found this on Prezi and it looks cool: http://prezi.com/fb4a6gilblcv/glutact-ip-2/. So why not take the next step making it easy for people to find you and contact you. 

 

A tip to all biotech (or other) startups- If you plan to do anything that might result in fifteen minutes of fame, make sure you have a website. Even one page with a description of your company (even if it is at an idea stage right now) and a contact email id is good enough. 

 

 

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CPRIT-funded agency ceases operations

CPRIT-funded agency ceases operations | Austin Life Sciences and Healthcare Updates | Scoop.it

The fallout from the state’s troubled cancer-fighting agency escalated Tuesday with the announcement that its largest grant recipient CTNet— a statewide cancer research network — has ceased operations and fired 30 employees.

Nishi Viswanathan's insight:

CPRIT, which was created to spend $3 billion over 10 years to find cures for cancers, has its own problems. Its top three executives have resigned, the agency is under criminal investigation, and the audit documented a laundry list of problems in its operations, including the handling of three large grants.

 

Another blow to the life sciences industry in the state. Hopefully, things will get resolved and CPRIT will be back in action soon. 

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Bad news for the Austin medical device community: Zimmer shutting down Austin operations

Bad news for the Austin medical device community: Zimmer shutting down Austin operations | Austin Life Sciences and Healthcare Updates | Scoop.it

Zimmer Spine, which makes and sells a variety of orthopedic surgical implants, told workers Thursday that it is closing down its Austin operations and consolidating them in Minneapolis and Memphis.

Nishi Viswanathan's insight:

The Austin operation, which includes product development, marketing and sales, currently employs about 100 people. An undisclosed number of Austin workers will be given the option to relocate to Minneapolis.

 

In 2011, after a wave of corporate restructuring, Susan Davenport, senior vice president of global technology strategies with the Austin Chamber of Commerce had stated “This was part of a restructuring across all Zimmer locations, and they are not backing out of Austin. Zimmer has given us assurance that they will remain and will probably be re-hiring.” But it has been two years since then and according to a recent statement, Zimmer has decided to "streamline its business".  

 

 

 

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Rolland Carlson,Ph.D named CEO of Asuragen

Rolland Carlson,Ph.D named CEO of Asuragen | Austin Life Sciences and Healthcare Updates | Scoop.it
Nishi Viswanathan's insight:

Asuragen Inc., a leading molecular diagnostic company, announced today that 
Rollie Carlson, previously the President and Chief Operating Officer of the Company, has been appointed President and CEO. Matt Winkler, the founder and prior CEO of Asuragen, will retain the role of Chairman of the Board and 
Chief Scientific Officer.

 

Based in Austin, Texas, Asuragen has its roots in Ambion®, “The RNA Company”, a highly successful molecular biology reagent company that was formed in 1989 by Matt Winkler, then a University of Texas professor. With a compounded annual revenue growth rate of 30%, Ambion quickly grew to become the preeminent reagent company focused around RNA.

 

In March 2006, the Senior Management team at Ambion sold the research products division to Applied Biosystems Group, an Applera Corporation business, and formed Asuragen with about 100 employees from Ambion’s Diagnostics and Molecular Biology Services Divisions.

 

Asuragen has exclusive rights to the Ambion patent estate as it pertains to human diagnostics and therapeutics. The new company is leveraging its RNA and miRNA expertise into molecular diagnostics, pharmacogenomic services, and therapeutics.

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ArthoCare buys out Calif.'s Eleven Blade - Austin Business Journal

ArthoCare buys out Calif.'s Eleven Blade - Austin Business Journal | Austin Life Sciences and Healthcare Updates | Scoop.it
Nishi Viswanathan's insight:

Austin-based developer and manufacturer of surgical devices, instruments, and implants, ArthroCare Corp. has reached a $7 million stock purchase agreement with Eleven Blade, a California company. The deal is contingent on Eleven Blade obtaining FDA clearance for certain suture-based anchor products.

 

ArthroCare, which was founded in 1993, also develops surgical products designed to enable minimally invasive procedures. The company employs about 1,600 workers. ArthroCare has operated at a loss three of the last four years. In 2011, it posted a $900,000 loss on revenue of $354.8 million versus a profit of $37.1 million revenue of $355.3 million during 2010.

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Medical care company Spinal Restoration secures $3 million - Austin Business Journal

Medical care company Spinal Restoration secures $3 million - Austin Business Journal | Austin Life Sciences and Healthcare Updates | Scoop.it
Austin-based medical company Spinal Restoration Inc. has secured a $3 million equity offering, according to documents filed with the U.S. Securities and Exchange Commission. In October, the company announced it had received $5 million in new funding.
Nishi Viswanathan's insight:

In October, the company announced it had received $5 million in new funding. Spinal Restoration had not filed documents with the SEC at the the time of the announcement. 

 

Spinal Restoration, founded in 2004, develops therapies designed to address unmet needs in spine health management. It employs seven workers and is headed by CEO Gary Sabins.

 

The company is currently conducting a Phase III clinical trial of Spinal Restoration’s Biostat®System, an investigational non-surgical procedure for chronic low back pain.

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Baylor Health Care System, Scott & White to Merge

Two already big Texas hospital systems have signed a letter of intent to merge in what will be the largest nonprofit integrated delivery system in the
Nishi Viswanathan's insight:

One more merger to add to the recent wave of consolidations in the healthcare industry. The deal will join together two of the most well-known hospital systems in Texas with Baylor dominating the north Texas market and Scott & White in central Texas.


The new organization will be known as Baylor Scott & White Health, said Joel Allison, president and CEO of Baylor, who will also be CEO of the new organization. Scott & White's CEO, Robert Pryor, MD, will be COO of Baylor Scott & White Health.

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FDA says Zimmer's recalled tool could be deadly - FierceMedicalDevices

FDA says Zimmer's recalled tool could be deadly - FierceMedicalDevices | Austin Life Sciences and Healthcare Updates | Scoop.it
Last week, Zimmer launched a worldwide recall of its PEEK Ardis spinal surgery tool, and now the FDA has slapped a Class I tag on the effort, warning that use of the device could result in serious injury or death.
Nishi Viswanathan's insight:

This announcement comes close on the heels of Zimmer's recall- http://www.fiercemedicaldevices.com/story/zimmer-pursues-global-recall-spinal-surgical-instrument/2012-12-20

 

 

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