dreamit-ventures

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.

barack-obama

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.

Human Genome

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.

med-startr-logo

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.”

md-dbed

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.

dollar-bills

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.

mass-life-sciences-center

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.

DHHS

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.

brain-to-bunker

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.

Qiagen

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.

m-and-t-bank

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.

NewImage

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.

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maryland-biotechnology-center

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.

bio-org-logo

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.