U.S. launch of therascreen® KRAS RGQ PCR Kit offers enhanced approach to guide treatments for approximately 110,000 patients annually in U.S. with colorectal cancer.
First FDA approval of a QIAGEN companion diagnostic marks a milestone in its global expansion of rapidly growing Personalized Healthcare business.
Important cancer assay adds valuable content for an expanding QIAGEN automation platform QIAGEN N.V. today announced it has received U.S. Food and Drug Administration (FDA) approval to market the therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) to provide guidance on the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer.
Maryland has named a longtime venture capitalist to head its program for investing in startups and early-stage companies.
Thomas Dann, founder and managing director at CastleHaven Advisors LLC, a D.C. private-equity firm, was named managing director of the Maryland Venture Fund.
A new U.S. Chamber of Commerce report names Maryland the #1 state in the nation for entrepreneurship and innovation. The annual report on 2012 Enterprising States, also ranked Maryland #1 in academic research and development and #3 in science, technology, engineering and mathematics (STEM) jobs and in the concentration of high-tech business locations.
"We are very pleased to see the State of Maryland receive this distinction," said University of Maryland Vice President for Research and Chief Research Officer Dr. Patrick O’Shea. "This national recognition reflects the efforts of the Governor and General Assembly to promote innovation across the state, the tireless work of the state’s successful businesses and entrepreneurs, as well as the University of Maryland’s dedication to creating a culture of entrepreneurship among our faculty, students and alumni."
As more drug manufacturers fight for a share of the market, those with biotech sales jobs understand that their companies’ success lies in its ability to develop innovative new products. Now, Maryland-based Human Genome Sciences has announced its breakthrough treatment for inhalational anthrax is one step closer to commercialization.
The company said the Food and Drug Administration (FDA) has acknowledged receipt of its resubmission of the Biologics License Application (BLA) for raxibacumab, a human monoclonal antibody that differs from other treatments because it targets anthrax toxins after they are released by bacteria into the blood and tissues of the body.
Human Genome Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.
The FDA has deemed the resubmission a complete, class 2 response to its November 14, 2009 complete response letter, which requested further analyses of existing data as well as additional information.
Fewer prospective investors applied for a share of Maryland’s $8 million in biotechnology investment tax credits Monday morning than a year ago, state officials reported.
Last year, the state received more than 180 applications from likely investors in qualifying Maryland biotechs within the first three minutes of the program’s annual online launch. On Monday, the state reported more than 125 registrations, which actually are made by the respective biotechs, between 9 a.m. and noon — more than the 115 applications received on the first day in 2010 but fewer than in 2011.
Johns Hopkins University is creating a new center to help public health agencies and accountable provider or payer groups better take advantage of health IT technologies.
The Johns Hopkins Center for Population Health IT, or CPHIT, is intended to broaden the focus of health IT systems including electronic health records and e-health beyond clinicians treating individual patients, says Jonathan Weiner, director of the new center. The idea is to "harness these health IT systems to create solutions for the many population health issues facing our nation," he says in a July 11 announcement.
What kind of community does Johns Hopkins offer for a scientist?
An excerpt of an interview in November of 2011, with Wes Blakeslee, Executive Director of Johns Hopkins Tech Transfer. In this segment, Wes talks about the unique environment that Johns Hopkins offers. Have lunch with a Nobel Prize winner. Be with the best of the best.
The Johns Hopkins Technology Transfer Office (JHTT) is the University’s intellectual property administration center, serving Johns Hopkins researchers and inventors as a licensing, patent, and technology commercialization office and acting as an active liaison to parties interested in leveraging JHU research or materials for academic or corporate endeavors. SNNLive spoke with Wesley Blakeslee, Executive Director of Johns Hopkins Technology Transfer Office at the BioMaryland booth at the BIO International Convention 2012 in Boston, MA.
Looking for a small-business loan? Then you might want to check out a new report from the U.S. Small Business Administration about which lenders have been the most active in the Baltimore area in the past nine months.
SBA’s Baltimore regional office found that M&T Bank was the biggest lender under SBA’s flagship 7(a) loans program for the period from Oct. 1, 2011 to June 30, 2012. That’s no surprise, since M&T, the second-largest bank in Greater Baltimore, has been the leading lender in the region for the past several years under the program. M&T wrote 157 loans totaling more than $17 million during the nine-month period under the 7(a) program, which guarantees loans for working capital, inventory and equipment.
Even as it completes an expansion in North Carolina, United Therapeutics is picking up for future use three buildings and a large parcel of land left idle by GlaxoSmithKline.
"We haven’t finalized our plans for the properties acquired from GSK," Andrew Fisher, chief strategy officer and deputy general counsel, says in an email to FiercePharmaManufacturing.
HHS has begun exploring ways to bring entrepreneurial spirit to provide fresh, innovative approaches to agencies. HHS already has the strong assets and the leadership to create and develop new products; The Innovation Fellows Program aims to bring external ideas and expertise into HHS’s own innovation process and rapidly create, develop, engage and accelerate innovation.
Startup organizations have demonstrated that rapid iteration between various versions or features of a product can yield successful results: HHS would like to boost innovation by working with external expertise to create a culture that encourages risk taking and dynamic new models of business.
President Barack Obama signed the US Food and Drug Administration Safety and Innovation Act (S. 3187) into law, reauthorizing user fees that the FDA charges pharmaceutical and device manufacturers as they gain approval for their products.
The law also establishes a new user fee program—raised as part of Obama’s newly-legitimized health care legislation—that will require companies making generic versions of protein-based drugs, or biologics, called biosimilars, to pay upon approval of their generic products. The newly signed law also makes several changes to FDA policy meant to speed the approval process for drugs and devices, enacts changes aimed to increase the safety of the drug supply chain, and incentivizes the development of new antibiotics.
A couple years ago, when Alex Fair was tossing around ideas on how to raise money for his new healthcare marketplace, FairCareMD, he knew that putting the startup on the uber-popular crowdfunding platform Kickstarter would be out of the question. Kickstarter has collected $250 million for 24,000 projects since it was founded three years ago, but virtually none of that has gone to health-related companies. “I said, ‘Hey, there’s an opportunity here,’” Fair says. “No one’s really doing health care crowdfunding.”
Enter MedStartr, Fair’s New York-based site that’s making its debut today. MedStartr allows entrepreneurs to find backers for healthcare technologies and services. The site, which Fair says ran a brief alpha test starting in April, is launching with six projects, including MedStartr itself. During that early project, which was designed to test the concept, Fair was surprised to find MedStartr was able to raise enough capital to run the company. “Of the 71 people we invited to view the alpha, six invested,” he says. It’s a sign, he believes, that “crowdfunding has hit the public consciousness.”
Venture capital fundraising for early stage funds doubled in the first half of the year to $3 billion compared with the same period last year, according to a report by Dow Jones.
Among the firms that have raised funds were Felicis Ventures, a well-respected early stage investment group with a new $70 million fund targeting bioinformatics, and other sectors.
Healthcare IT companies are likely to benefit from the increase as healthcare facilities shift to electronic medical records.
Today, the President signed into law S. 3187, the “Food and Drug Administration Safety and Innovation Act.” This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our Nation’s role as a leader in biomedical innovation.
S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring drugs and devices to market safely and quickly and promote innovation in the biomedical industry, and to help secure the jobs supported by drug and device development.
In a small, anonymous office in the Trump Tower, 28 floors above Wall Street, a man sits in front of a computer screen sifting through satellite images of a foreign desert. The images depict a vast, sandy emptiness, marked every so often by dunes and hills. He is searching for man-made structures: houses, compounds, airfields, any sign of civilization that might be visible from the sky. The images flash at a rate of 20 per second, so fast that before he can truly perceive the details of each landscape, it is gone. He pushes no buttons, takes no notes. His performance is near perfect.
Or rather, his brain’s performance is near perfect. The man has a machine strapped to his head, an array of electrodes called an electroencephalogram, or EEG, which is recording his brain activity as each image skips by. It then sends the brain-activity data wirelessly to a large computer. The computer has learned what the man’s brain activity looks like when he sees one of the visual targets, and, based on that information, it quickly reshuffles the images. When the man sorts back through the hundreds of images—most without structures, but some with—almost all the ones with buildings in them pop to the front of the pack. His brain and the computer have done good work.
SNNLive had the pleasure of speaking with Dr. Judith Britz, Executive Director of Maryland Biotechnology Center and Francois Chevillard, CEO of the Medicen Paris Region to announce the two organizations’ Memorandum of Understanding at the BIO International Convention 2012 in Boston, MA.
The Maryland Biotechnology Center is an organization within the Maryland Department of Business and Economic Development (DBED) that consolidates and coordinates a host of state, university and private sector initiatives to better showcase and support biotechnology innovation and entrepreneurship in Maryland. The Medicen Paris Region facilitates the transfer of innovation to industry, the market and patients in human healthcare sectors.
Cash-burning R&D-stage biotechs have big appetites for cash, which is typically addressed with an equity-based diet. It’s also supported through corporate partnerships and other less dilutive means such as grants and foundation funding. But another important and often under-appreciated source of capital are the debt markets – taking a loan out to provide working capital for further R&D.
One might ask why and how a company that won’t have profits for a decade can raise any money through the issuance of debt, but it happens frequently, and the “venture lending” business is actually very robust. Players like Silicon Valley Bank (SVB), Oxford Finance, Hercules Technology Growth Capital, and Horizon Technology Finance (and many others) are all very active supporters of emerging life science companies.
Healthcare IT has become a new priority for East Coast accelerator DreamIt Ventures with the hire of a veteran angel investor group director.
Karen Griffith Gryga recently joined the accelerator’s Philadelphia office. Earlier this year it added a minority-led business component and started a program to work with startups based in Israel.
She has worked as executive director of Mid-Atlantic Angel Group, which has invested in life science and technology companies.
The Commonwealth of Massachusetts’ quasi-public agency, the Massachusetts Life Sciences Center, has opened its 2012-2013 Accelerator Loan Program, the agency announced Monday.
MLSC launched the program in 2009 as a way to help startup businesses who need working capital or funding to pay for capital assets. A loan of up to $1 million per company is provided, an increase from the maximum amount of $750,000 offered in the past. The decision to increase the amount available was made during a June meeting of the board of directors, according to Angus McQuilken, vice president of communications at the MLSC. Companies still will only be able to borrow a dollar-for-dollar match, he said.
On June 21 the Biotechnology Industry Organization (BIO), which represents biotechnology companies, issued a report on the economic impact of patent licensing from universities and non-profit institutions (PDF), analyzing data from 1996 to 2010 gathered by the Association of University Technology Managers (AUTM). The data show that patent licensing resulting from federally-funded research at universities and non-profits resulted in contributions to GDP somewhere between $86 billion and $388 billion in 2005 U.S. dollars, and between 900,000 to 3,000,000 person-years of employment in that period.
Seven pharmaceutical companies and four research institutions, working with the Bill & Melinda Gates Foundation, have launched a groundbreaking partnership, to expedite the discovery of new treatments for tuberculosis. The partnership, known as the TB Drug Accelerator (TBDA), will target the discovery of new TB drugs by collaborating on an early-stage research. The long-term goal of the TBDA is to create a drug regimen that cures patients in just one month. Existing drugs, which are all at least 50 years old, require six months to cure the disease — a lengthy process, during which at least 20 to 30 per cent of patients end up discontinuing the treatment before the completion of the course.
Imagine for a moment you’re a hotshot biomedical scientist at a university. You have invented a technology in your lab that you think has potential to make a big difference for the world of medicine. Despite all the accolades you might be getting in Nature, you are savvy enough to know you still have a pretty raw concept. Your idea needs someone who can build a business around it, and invest a lot of time, money, and talent to prove it’s the real thing.
Who would you call?
There aren’t that many people who you can call anymore, and the number is shrinking. This question has been gnawing at me for a while, as I’ve sought to understand the historic contraction that’s occurring in the biotech venture capital business, and what effect it will have on the biotech industry’s ability to turn bright ideas into valuable new healthcare products.
Maryland’s secretary for business and economic development rallied Lower Shore leaders behind a state venture capital initiative that seeks to invest millions of dollars into companies and entrepreneurs with innovative ideas.
The state is poised to award a total of $84 million raised through an online tax credit auction earlier this year, but Lower Shore companies that don’t apply cannot benefit from the infusion known as InvestMaryland, Christian S. Johansson, secretary of the Maryland Department of Business and Economic Development, told leaders gathered in Salisbury on Monday to unveil the new facility of the Tri-County Council for the Lower Eastern Shore of Maryland.
BioHealth Innovation (BHI) is a regionally-oriented, private-public partnership functioning as an innovation intermediary focused on commercializing market-relevant biohealth innovations and increasing access to early-stage funding in Maryland.
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