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.

post-doc-conf-logo

July 12, 2012 - Bethesda North Marriott/Montgomery County Conference Center

A conference and career fair for current postdoctoral fellows working in Washington, D.C. area federal labs and universities, and for companies recruiting high-level S.T.E.M. (Science, Technology, Engineering and Mathematics) professionals.

This event exposes area postdoctoral fellows in the S.T.E.M. fields to the many career options (e.g., government, private sector, entrepreneurship) that are available to them.

The career fair portion connects local job-seeking postdocs with companies seeking that level of talent.

united-therapeutics

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.

glaxosmithkline

GlaxoSmithKline PLC said Friday it has again extended its $2.6 billion hostile offer for shares of Human Genome Sciences Inc., its collaborator on the lupus drug Benlysta.

GlaxoSmithKline of London said its offer will expire July 20. The bid values Human Genome Sciences at $13 per share and was scheduled to expire Friday. Around 375,000 shares of Human Genome Sciences have been tendered in support of GlaxoSmithKline's offer. That's less than 0.2 percent of the 199.1 million Human Genome Sciences shares on the market and represents a small decrease in support from June 8.

enterprising-states-2012

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."

md-dbed

The registration date for Maryland’s popular biotechnology tax credit program has been rescheduled because of wide-spread power outages.

Online registration for the Maryland Biotechnology Investment Incentive Tax Credit will open at 9 a.m. July 9. Registration was moved from July 2 out of concern that some investors would not be able to participate because of the power outages affecting hundreds of thousands of homes and businesses in the Baltimore area.

BioBeat

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

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.

bill and melinda gates foundation

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.

MedImmune

MedImmune, the global biologics arm of AstraZeneca, today announced that the company’s expansion project at its Frederick, Md., Manufacturing Center (FMC) won the International Society for Pharmaceutical Engineering’s overall 2011 Facility of the Year Award.  This is the first time MedImmune has won this prestigious internationally renowned accolade.    

The annual Facility of the Year Awards (FOYA), sponsored by the ISPE, INTERPHEX and Pharmaceutical Processing magazine, recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

Houses

If you are planning to submit an SBIR/STTR proposal to the National Institutes of Health (NIH) before the August 5 deadline, one of your first considerations should be which of its many Institutes/Centers (IC) will be a fit for your project.

The NIH is an umbrella organization with 27 Institutes/Centers within its purview. Even though you submit a single SBIR/STTR application to NIH, your application is typically “housed” in one of the ICs after funding decisions are made. The program managers at each of the ICs are able to provide some feedback on the fit between your SBIR/STTR project and the IC. So here are two BBC tips to get you started.

united-therapeutics

United Therapeutics Corporation (NASDAQ: UTHR) today announced  that its Board of Directors authorized the repurchase of up to an additional $100 million of the company's common stock.  This program will become effective on July 31, 2012, and will remain open for up to one year.  Purchases may be made in the open market or in privately negotiated transactions from time to time as determined by United Therapeutics' management and in accordance with the requirements of the U.S. Securities and Exchange Commission.

The company also announced that it had recently completed its previously-announced $300 million repurchase program by purchasing 2,045,192 shares of common stock for $88 million during the second quarter of 2012.

med-startr-logo

Crowdfunding—the new, hip way to raise money for early-stage technologies and interesting projects—has found a happy home in the world of high-tech, where many people are eager to experiment with new models and new approaches.

But can the same model work for the much stodgier health-care industry?

The founders of MedStartr, a crowdfunding platform for medical technologies, say that it will. On the 4th of July, the site will go live, with dozens of health-related technologies and services looking for benefactors.

Qiagen

Aim to expand next-generation sequencing beyond current focus on life sciences research.

QIAGEN plans to offer sample-to-result workflows that integrate its sample preparation and assay products with a next-generation benchtop sequencer and new bioinformatics

Initiative combines broad range of QIAGEN products with acquisition of sequencing specialist Intelligent Bio-Systems, Inc. and a new strategic collaboration with SAP AG QIAGEN N.V. QGEN today unveiled an advanced initiative to enter the field of next-generation sequencing (NGS) that aims to establish these technologies as routine processes used in new areas such as clinical research and molecular diagnostics.

Anthony Coyle

The drug discovery business is going through tough times. Drug candidates aren't moving through the pharmaceutical industry's pipelines fast enough. Meanwhile, entrepreneurs struggle to get the funding they need to bring their new ideas to fruition. These issues are driving new alliances and partnerships between academic researchers, venture capitalists, and big pharma, but whether the new models will solve the problem was a question on the minds of many of the 15,000 attendees at this week's BIO International Convention in Boston.

The themes are familiar: venture capitalists are limiting their investments in biotech, in part because it's hard for fledgling life-science companies to go public, and although big pharma is desperate for innovative ideas and depends heavily on small biotechs for new drug candidates, these larger companies don't want to take on risky, early-stage projects. The new alliances, some of which involve direct collaborations between pharmaceutical companies and academics, are a response to what one panelist called this "crisis."

As you may know, the Montgomery County Department of Economic Development (MCDED) led the County's participation at the 2012 BIO International Convention held June 18-21 in Boston, MA.

Our team of business development professionals participated in dozens of business partnering forum meetings with national and international biotech companies during the course of the Convention.  On June 19,  MCDED held a press conference from the floor of the BIOMaryland Pavilion, kicked off by Human Genome Sciences CEO and Biotechnology Industry Organization (BIO) Board Chairman Tom Watkins and Montgomery County Executive Isiah Leggett.  The press conference highlighted the success of the County's biotech investment incentive program - the nation's ONLY such local program which helped spur more than $6 million in investments to 10 County-based biotech companies in 2011 -  and the creation of the County-inspired, regional biotech intermediary BioHealth Innovation, Inc. (BHI).  BHI is chaired by Scott Carmer, Executive Vice President, Commercial Operations, MedImmune and sponsored by Human Genome Sciences and several other local private-sector companies and academic institutions.  The press conference also featured a panel, moderated by MedImmune CEO Peter Greenleaf, of County-based, serial biotech entrepreneurs discussing why and how they started companies in Montgomery County.

California

At least 68 “big” deals — investments of at least $2 million — have been done in digital health so far in 2012, according to a new report by the healthcare accelerator Rock Health. Nineteen states were in on the action.

Not so surprising, California lead the way in both the number of deals done and the overall investment. And traditional healthcare investing strongholds like Massachusetts were among those that did the most deals. But there were lesser known regions involved as well that invested significant dollars and did a notable number of deals, namely Texas, Illinois, Georgia and Connecticut.

Here’s a list of every region that did digital health deals so far this year.

Apple Cherry

At least 68 digital health companies have raised $2 million or more so far this year for a total of $675 million in digital health investments, according to a new report by healthcare accelerator Rock Health.

Look closer, though. Five companies accounted for nearly 40 percent of those total dollars.

It’s clear that patient shopping tools and home health technologies are where the big bets are going. Here’s the breakdown of the Big 5 deals.

Human Genome

US biotechnology firm Human Genome Sciences (HGS) has set a deadline of 16 July 2012 for offers to acquire the company, but has failed to tempt GlaxoSmithKline (GSK) into the process.

HGS has undertaken the strategic alternative review to sound out potential buyers who now have until the deadline to submit definitive proposals to purchase all outstanding common shares in the company.

The company adopted the strategy immediately after GSK made its offer to acquire HGS, valuing the company at $2.6bn.

Startup maryland

The entrepreneur support and advocacy group founded this spring will crisscross the state on a two-and-a-half-week bus tour in September. The trip starts Sept. 11 with a trek to Ocean City and is scheduled to wrap up Sept. 28 in Howard County after canvassing the rest of the state.

At stops along the way, Startup Maryland will roll out the first round of its business pitch competition. Organizers said they are still working out how much prize money will be distributed and how it will be divvied up.

BIOSTL

Four new Entrepreneurs In Residence (EIRs) have joined the BioGenerator, a nonprofit subsidiary of BioSTL, to create, lead, and support new bioscience companies St. Louis. The EIRs will work with existing start-up companies across the region to further their growth and with researchers and entrepreneurs to launch new enterprises.

In just the last two years, BioGenerator’s new programs for pre-seed funding (Spark Fund and i6 Project) and shared laboratory facilities (Accelerator Labs), along with its historical seed funding program, have supported the creation of 17 new bioscience companies in St. Louis, validating the rich supply of bioscience innovation locally. These new EIRs will help to advance the growth of existing companies and assist in the creation of additional regional startups.

bio-internation-convention

Maryland’s biotechs continued to leave their mark on the industry at this week’s global convention in Boston, with several executives claiming prominent board positions and a new report showing the state outpacing national growth in life science employment.

More than 15,000 executives and others were expected at this year’s Biotechnology Industry Organization International Convention, which started Monday and ended Thursday. More than 31 state companies sought the world’s attention at the Bio Maryland 2012 pavillion, which the state also had at last year’s convention in Washington, D.C.

Rich Bendis

Innovation and creation are at the heart of the biotech industry and close to the heart of international business development consultant Richard A. Bendis.

Bendis, 65, has devoted almost 40 years to helping enterprises grow, in both the public and private sector.

Most recently, Bendis was named CEO of the new regional effort to foster commercialization of federal and university laboratory innovations and increase access to early-stage funding for biotechs. BioHealth Innovation of Rockville is a nonprofit private-public partnership that leverages the resources of several biotechs and research institutions, including the University System of Maryland and Johns Hopkins University, in the Baltimore-Washington, D.C., region.

johns-hopkins-center-bio-ed

The Johns Hopkins Center for Biotechnology Education (CBE) welcomed more than 20 academicians onto campus last weekend for the 1st Annual International Bioentrepreneurship Education Conference (BEC). During the one-day event, bioentrepreneurship education leaders from as far away as South Africa, South Wales, Sweden and Denmark – as well as a number of stateside leaders – met to share information and assess where bioentrepreneurship education currently stands.

One of the biggest takeaways: Similar to entrepreneurs, academic leaders are concerned about funding resources. In the case of academia, the concern was identifying resources that can help support these exciting, and in many cases, new programs.

bio-internation-convention

On the last full day of the BIO Convention, Tom Watkins, President and CEO of Human Genome Sciences and Chairman of the Board for BIO, reviewed the major policy advocacy activities of BIO over the past year at the Keynote luncheon session.

BIO has advocated for expedited approval of biosimilars in the passage of the Biosimilars User Fees act (BsUFA), and has been working to ensure policy changes that enhance transparency and help minimize review times FDA approvals are included in the fifth renewal of the Prescription Drug User Fee Act (PDUFA) which is anticipated to pass later this year.

johns-hopkins-medicine

The Johns Hopkins University School of Medicine, in collaboration with the Johns Hopkins Health System (together known as Johns Hopkins Medicine, or JHM), has been awarded a $19.9 million grant by the Centers for Medicare & Medicaid Services (CMS), over a three-year period, to improve the quality and efficiency of health care delivered to JHM patients.

The grant is part of CMS’s $1 billion Healthcare Innovation Challenge, a competitive initiative that seeks to identify and support innovative opportunities to improve care delivery and achieve its three-part aim of “improving the individual experience of care, improving the health of populations, and reducing the per capita costs of care for populations.”

tesaro-logo

Tesaro, a biotech focused on the treatment of chemotherapy-induced symptoms, announced terms for its IPO on Tuesday. The Waltham, MA-based company plans to raise $81 million by offering 6.0 million shares at a price range of $12 to $15. At the midpoint of the proposed range, Tesaro would command a market value of $360 million.

The company's lead product candidate, rolapitant, is in Phase 3 trials, the results of which are expected in the 2H13. No revenue has been generated to date. Venture capital firms New Enterprise Associates, InterWest Partners and Kleiner Perkins will hold 39%, 10% and 7% post-IPO stakes, respectively. Certain undisclosed insiders have expressed an interest in purchasing approximately $25 million of stock in connection with the offering.

md-dbed

Maryland’s economic development office has formed a partnership with a Paris region to team on disease research and translational medicine.

The letter of intent for the partnership was signed Wednesday at the Bio 2012 International Convention in Boston by Christian Johansson, secretary of the Maryland Department of Business and Economic Development, and Paris Medicen Del. Gen. Francois Chevillard. The Paris Medicen region is considered a life sciences hub in France’s capital city.

Md bio enterprise

Trying to meet the future work force where it is, some Maryland biotech executives are backing a unique strategy to help market an educational video game to students.

A version of one game, developed by Hunt Valley gaming company BreakAway Ltd., is being previewed at the annual Biotechnology Industry Organization International Convention this week in Boston. The MdBio Foundation, an affiliate of the Tech Council of Maryland, will offer the game to science teachers free of charge beginning next year, with help from financial partners.

EAGB Logo

The Economic Alliance of Greater Baltimore (EAGB) announced today that it has completed a formal agreement to serve as Greater Baltimore's primary business partner with BioHealth Innovation (BHI), Maryland's private-public collaborative that focuses on commercializing market-relevant bio health innovations and increasing access to early-stage funding in central Maryland.

BHI is the first regionally focused innovation intermediary created to connect the university and hospital bio health research strengths of Baltimore with the bioscience industry and federal laboratory strengths of Montgomery County.