QIAGEN N.V. today announced a partnership with Clovis Oncology CLVS +1.11% to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently in clinical development. The Clovis drug candidate will initially target an unmet clinical need in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for whom current EGFR-inhibiting drugs no longer control disease.

The diagnostic will build on QIAGEN's therascreen® EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a companion diagnostic for use in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of the QIAsymphony family of laboratory solutions.

Governor Martin O’Malley today joined with Montgomery County Executive Isiah Leggett and City of Gaithersburg Mayor Sidney Katz  to announce that Emergent BioSolutions is expanding into a new headquarters building in Gaithersburg, and also plans to make improvements to its existing Research and Development site. As part of the expansion, the global pharmaceutical company will retain its existing 235 employees, and hire an additional 133 employees over the next five years.

“Emergent BioSolutions’ continued investment in Maryland helps solidify our position as a life sciences powerhouse,” said Governor O’Malley. “I am proud that Emergent BioSolutions is growing in Maryland, continuing to create jobs and working to develop life-saving vaccines that will give hope to millions of people around the world.”

This Notice is to provide NIH’s extramural community with information on how NIH is resuming operations after the government shutdown.

eRA Systems Availability

eRA systems will be available for use by the applicant/grantee/reviewer community on Monday, October 21. 

Rescheduling October Application Due Dates

All October grant application due dates have been rescheduled as follows: Standard Due Dates:

Cleveland Clinic is in the midst of its annual Cleveland Clinic Medical Innovation Summit today at the new Global Center for Health Innovation. More than 1,100 entrepreneurs, investors, executives and clinicians have gathered for a show and tell of new ideas in the medical world. Cleveland Clinic Chief Information Officer C. Martin Harris talks about how the health system stays nimble on the innovation front.

Cleveland Clinic Innovations, the corporate venturing arm of Cleveland Clinic, was founded in 2000, and it has been hosting the Medical Innovation Summit since 2003. Since Cleveland Clinic Innovations was founded, it has:

When Pascal Soriot took the reins of AstraZeneca last fall, he said he planned to corral firms with promising innovations in their pipeline to reinvigorate the Anglo-Swedish pharma’s offerings.

And so he has – to the tune of more than $1 billion.

Since the former chief operating officer of Roche AG was named CEO on Oct. 1, 2012, the firm has made five acquisitions, five collaborations with other pharmas to develop drugs, and entered two licensing deals. Six of the 12 moves are tied to cancer treatment developments, a core focus for the firm, while the remaining are in diabetes and renal, kidney, cardiovascular and respiratory diseases.

The research, by Gary Dushnitsky, Associate Professor of Strategy and Entrepreneurship, London Business School and his co-author Dr Alvarez-Garrido, is featured in the British Venture Capital Association’s report ‘The Missing Piece’ and finds that corporate venture capital is now the driving force behind cutting edge medical innovation.

Dr Dushnitsky, also Academic Director, Deloitte Institute for Innovation and Entrepreneurship, said, “Biotech start-ups are increasingly turning to corporate venture capital arms, which are steadily on the rise, while traditional venture capital funds are partially drying out.  In a recent Nature Biotechnology study, my co-author and I find that the shift in funding patterns is resulting in an increase in scientific publications as well as patenting output.

There is one certainty about the current regulatory process for drug approval in the United States and Europe: No one likes it.

Manufacturers are frustrated by the need for large, complex, and lengthy clinical-development programs that often hinge on meeting a single endpoint in one pivotal clinical trial. As a result, the cost to bring a drug to market has been estimated to be well over $1 billion — and it may be much higher. Patients and providers are disturbed by lack of timely access to medicines that show early promise in addressing significant unmet needs. Even regulators, who are responsible for enforcing the current structure, chafe at what manufacturers typically present to them: successful trial results in patients who are carefully selected to show the drug offers benefits but who are not very representative of the broader population likely to receive it. Payers then have a mess on their hands: pressure to pay for premium-priced medications that, when broadly employed, don’t offer much therapeutic benefit over existing alternatives.

Nutty things are happening in biotech. Irrational exuberance has returned. Generalist investors with lots of money are suddenly buying these stocks first and asking questions later. Companies can fire off meaningless press releases, and be rewarded. I heard a big-time money manager talk the other day about a recent biotech IPO being one of the “best performers” in the market. It had a two-week track record, and had done nothing fundamental to earn its tag as a “best performer.”

If markets are driven by cycles of fear and greed, and I believe they are, we are in the greed cycle.

CareFirst BlueCross BlueShield will offer up to $1.5 million in grants to help medical providers develop telemedicine-based behavioral health services, the Baltimore insurer announced this week.

CareFirst wants to seed projects that use video conferencing or other technologies to allow doctors and others to diagnose and treat patients remotely.

Christy Wyskiel is the new senior adviser to the president for enterprise development at Johns Hopkins University. Wyskiel has previously worked as an investor in early stage and startup companies. She has also provided business and management support to startups, such as Hopkins spinout GrayBug.

Wyskiel officially takes on her new role leading Hopkins’ tech transfer office Jan. 1. But she’s already busy getting the lay of the land and helping map out what will come next for Hopkins with regard to technology commercialization.

Investors are pouring venture capital dollars into the Washington region at a pace not seen in more than a decade.

Companies across the Washington region have attracted $1.15 billion in the first three quarters of the year, more money than the first three quarters of any year since 2001.

As an African-American man entering a Caucasian-dominated industry, Solomon Graham wasn’t intimidated when he founded Quality Biological in 1983, investing $10,000 of his own money to start the business.

The Gaithersburg company is one of the longest-operating biotechs in Montgomery County and has grown into a multimillion-dollar enterprise. It provides products and supplies for molecular and cell biology laboratories to use in infectious disease and cancer research.

Investments in electronic health records, tools to help hospitals absorb physician practices anda group working with hospital systems to help them set up their own insurance plans. Those three health IT companies helped drive venture capital investment in the software sector, which hit a 12-year high in the third quarter. Medical device and biotechnology companies collectively marked their lowest investment for a nine month period since 2005, according to the MoneyTree Report by PricewaterhouseCoopers and the National Venture Capital Association. It is based on data from Thomson Reuters.

About $3.6 billion was invested in the software sector and there were 42o deals in the quarter.

You can purchase 14 gallons of organic milk or 396 lollipops. You can give her 33 rides on the Ferris wheel at the state fair, or you can get him a couple of violin lessons. You could put the money in a savings account, you could buy her her very own LeapFrog LeapPad Explorer digital learning tablet, or you could buy enough pizzas to feed all of her friends on the block. So many options, so many choices.

I took that money and got my daughter's genes tested, ordering up an analysis of the composition of her very small self and its odds of living a long and healthy life. And in so doing, I in some small way tied her fate to the success of the company doing the analysis, a genetic-testing startup called 23andMe in Mountain View, California.

The latest of edition of Mtech News published by Maryland Technology Enterprise Institute.

AstraZeneca and Taiwan’s National Research Program for Biopharmaceuticals (NRPB) today announced a collaborative program to support academic research proposals using open innovation as a catalyst for drug discovery. The program will connect expert physicians and scientists with a wide range of high-quality, small molecule compounds and biologics developed by AstraZeneca.  

Successful research proposals submitted from academic institutes in Taiwan will be funded by the NRPB to explore new therapeutic uses for specific AstraZeneca compounds which may in turn lead to the development of novel therapies for patients. Further financial details were not disclosed. Areas of high interest include cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.

Billionaire oilman T. Boone Pickens plans to give Johns Hopkins University $20 million to help spur potentially vision-saving research at the school’s Wilmer Eye Institute.

The gift will be included in the 85-year-old’s estate and will create an endowment to fund a T. Boone Pickens Scholars program supporting scientists.

Each year, a committee of Cleveland Clinic doctors asks hundreds of their colleagues to weigh in on which emerging healthcare technologies they think will help shape their practice over the next 12 months.

Then, the committee evaluates nominations based on clinical impact, probability of commercial success, progress in commercialization and significant human interest, and produces a top 10 list announced at the end of the Clinic’s annual Medical Innovations Summit.

Biocrossroads, which provides money and support to Indiana’s life sciences industry, announced the seven finalists who stand to gain startup funding in its annual New Venture Competition. Six have biotech or healthcare in their sights. On Oct. 21, five of these companies will compete for $25,000 and access to the Indiana Seed II Fund‘s staff and network for early-stage business support at the Indiana Life Sciences Summit. Second and third place in this competition will rake in $15,000 and $10,000 respectively.

“The New Venture Competition has proven to be a great way for us to find and reward promising companies, and is an excellent opportunity for the competingcompanies to gain some exposure within Indiana’s life sciences community,’ David Johnson, president and CEO of BioCrossroads, said in a release.

StartUp Health, a New York-based incubator for health technology startups, admitted 14 new companies into its three-year development program this week. The program, which received 1,200 applications in the past year, aims to give new medical companies long-term mentoring and access to capital.

The new entrants include companies working on medication adherence, remote medical services and patient engagement in physical therapy. Cohero Health, a one-year-old company based in New York, aims to help kids with chronic asthma manage their condition.

Your liver could be "eating" your brain, new research suggests.

People with extra abdominal fat are three times more likely than lean individuals to develop memory loss and dementia later in life, and now scientists say they may know why.

“When I was a young entrepreneur, board meetings were by far the worst days of my life,” says Jeff Bonforte, the veteran company-builder who just sold his latest, Xobni, to Yahoo. “Board meetings are the height of insecurity for a CEO. Basically it’s a group of people who can both judge you and fire you based on that judgment.” 

He’s had his fair share of bad experiences. At his first company, iDrive, he'd find himself every quarter standing in front of the room, sweating bullets, struggling to get through his meticulously-prepared slides. “It was a mess,” he says. “They’d just sit there and tell me how insufficient I was, how I needed to bring in someone more senior, or smarter. Then it just hit me. I don't need this. I don't need people to attack me for four straight hours. I need people who can help me.” 

Under Armour Inc. is hunting for the techies that can help the company beef up its fitness tracking device known as Armour39.

Armour39, a digital performance monitor launched in March, tracks an individual’s heart rate, calories burned and workout intensity, and provides a “WILLpower” score that reflects how hard an individual trained during a workout.

MedImmune's venture arm has jumped in to lead a $12.5 million round for a Chapel Hill, NC-based startup that is working on a new drug to treat a common ailment spurred by chemotherapy. G1 Therapeutics, which was initially seeded by Hatteras Venture Partners to the tune of $600,000, says that the new funds will finance its IND work and point the company to proof-of-concept data on a drug designed to protect against myelosuppression--the loss of blood cells--during chemo. Hatteras Venture Partners and Mountain Group Capital contributed to the round.

G1 was founded on the work of Norman Sharpless at the University of North Carolina in Chapel Hill and Kwok-Kin Wong at Harvard Medical School. They concluded that a cyclin-dependent kinase 4/6 inhibitor could play a big role in protecting the bone marrow of chemo patients.

QIAGEN N.V. (frankfurt prime standard:QIA) today announced the Empowered Genome Community, which is a first-of-its-kind initiative to help people who have had their genomes sequenced share, explore, and interpret their data with researchers and each other. To highlight how the community can spark new biomedical insight, QIAGEN also released an open collaborative analysis of myopia in 111 people whose genomes were sequenced through Harvard's Personal Genome Project (PGP), which is a public repository of well-phenotyped human genomes. Anyone - citizen scientist or full-time researcher alike - can directly review and help refine the analysis via QIAGEN's Ingenuity® Variant Analysis(TM) (https://variants.ingenuity.com/community-myopia) with the goal of jointly publishing robust insights on myopia next year.

A prominent health system CEO implored the Washington region's employers to not drop their company health plans in response to the Affordable Care Act, predicting disastrous consequences for the industry if they do.

So far, most companies aren't taking that step. But enough have to raise the alarm for William "Bill" Robertson, CEO of Gaithersburg-based Adventist HealthCare, which operates two Montgomery County hospitals and network of affiliated services.

The Nobel Assembly at the Karolinska Institute announced today that Randy W. Schekman, a Howard Hughes Medical Institute (HHMI) investigator at the University of California, Berkeley, Thomas C. Südhof, an HHMI investigator at Stanford University, and James E. Rothman of Yale University are the recipients of the 2013 Nobel Prize in Physiology or Medicine for their discoveries of machinery regulating vesicle traffic, a major transport system in our cells.

According to the Nobel Assembly, this year's Nobel Prize in Physiology or Medicine honors three scientists who have solved the mystery of how the cell organizes its transport system. Each cell is a factory that produces and exports molecules. For instance, insulin is manufactured and released into the blood and chemical signals called neurotransmitters are sent from one nerve cell to another. These molecules are transported around the cell in small packages called vesicles. The three Nobel Laureates have discovered the molecular principles that govern how this cargo is delivered to the right place at the right time in the cell.

Osiris Therapeutics shares rose Friday morning after the company said it is selling some of its stem cell therapy technology, including its transplant treatment Prochymal, to Mesoblast Ltd. in a deal that could be worth more than $100 million.

Prochymal treats bone marrow transplant cells that attack the recipient’s body, and it is approved in Canada and New Zealand but isn’t being sold. Osiris said it wants to focus on businesses with the greatest commercial potential. Its remaining products include Grafix, which is used to treat chronic and acute wounds, Ovation, which is used in tissue repair, and Cartiform, a treatment for acute cartilage injury.

There have been more than 30 initial public offerings of biotechnology companies so far this year, and there’s a line around the block of promising new entrants looking to debut on the public markets.

Angelika Warmuth/European Pressphoto Agency But don’t call it a bubble. Those in the know are calling it a boom, and saying the good times are likely to continue for biotech, even in the face of clinical setbacks and other bumps in the road.

The health care industry has survived economically by cross-subsidizing margin shortfalls in one activity with the revenues generated from others. But the very existence of these cross-subsidies is symptomatic of deep flaws in the health care reimbursement system. As we move forward we need to be mindful of two principles that must be at the heart of any fundamental health care reform:  “no margin, no mission” and “if you can’t measure it, you can’t manage it.” As the era of health care cross-subsidization ends, these principles must guide our actions.

MedImmune, the global biologics research and development arm of AstraZeneca, has acquired Spirogen, a privately-held biotech company focused on antibody-drug conjugate technology for use in oncology.

MedImmune will acquire 100 per cent of Spirogen’s shares for an initial consideration of $200 million and deferred consideration of up to $240 million based on reaching predetermined development milestones. Existing out-licensing agreements and associated revenue streams are excluded from this acquisition.

Shares of MacroGenics are surging in Thursday midday trading after the biotechnology company raised $80 million in its initial public offering.

MacroGenics sold 5 million shares of stock for $16 per share. It had expected to sell 4 million shares for $14 to $16 each. The $80 million total does not include expenses or underwriting discounts.

People love to rank U.S. biotech clusters. Most of these reports are full of data on venture financing, patents, jobs, and NIH funding. But many are riddled with flawed and biased methodology, and are usually designed to push a political agenda.

These rankings, which many people take at face value, have been irritating me for a long time. So last week, I decided to ask a few different questions in order to compare the relative strength of biotech hubs we cover at Xconomy.

Here’s what we know about the Affordable Care Act: 32 million Americans who would otherwise be uninsured will now have coverage. What you might not know is that Obamacare could also boost entrepreneurship by decoupling healthcare from employment.

How would that work? Existing research estimates that universal health insurance coverage could increase self-employment by as much as 3.5 percent. The reality is that many would-be risk-takers stay with their employers in large part due to the assurance of health insurance, in what economists refer to as “job lock,” or “entrepreneurship lock.” But, this pressure to be employed by a larger company is loosening as the Affordable Care Act makes it easier and less expensive to purchase individual coverage. Now, hopeful entrepreneurs can go out on their own in a far more efficient allocation of their skills, without gambling their own health coverage, or that of their family.

If UMD researchers are well on their way to creating a robot that can wiggle through the brain to root out the tumors deep within, then anything is possible. Plankton crawled through Spongebob's cranium and now Dr. J. Marc Simard, a neurosurgeon at the University of Maryland School of Medicine; Jaydev Desai, a roboticist at the University of Maryland; and Rao Gullapalli, a radiologist, believe they're developing something that can do the same.

It was Dr. Simard who fist came up with the idea after watching a show on TV featuring plastic surgeons using sterile maggots to root out damaged tissue from a patient. "It sounds strange, but it's a real thing," he said in an interview with NPR. That's when the lightbulb went off. "If I could train maggots to resect brain tumors I would. I can't do that, so robotic maggots are the next best thing."