University System of Maryland

This week, the University System of Maryland (USM) announced that smoking would no longer be permitted on any of the 12 USM campuses, including the flagship University of Maryland at College Park.

The policy, which will take effect on June 30, 2013, prohibits smoking on campus grounds, outdoor structures, and in school vehicles. Each university president, however, will be able to designate a “very limited area” where smoking may occur without interfering with the health of others.

Congress

Companion bills were introduced in Congress on April 25th of this year with little fanfare (particularly in comparison to the Leahy-Smith American Invents Act) but they have the potential to provide significant funding for university-related start-up companies.  The bills, H.R. 4720 and S. 2369, are entitled the "America Innovates Act of 2012" and are sponsored by Reps. Rush Holt (D-NJ) and Timothy Bishop (D-NY) in the House of Representatives and Sens. Frank Lautenberg, Jerrod Brown (D-OH), and Kirsten Gillibrand (D-NY) in the Senate.  They have been referred to their respective committees (the House Sub-Committee on Technology and Innovation and the Senate Committee on Commerce, Science, and Transportation), but to be frank it is unlikely that they will receive positive action in this election year.

SBIR STTR

Proposed rules for the Small Business Innovation Research program could allow foreign-owned companies to compete for these federal R&D awards, according to the Small Business Technology Council.

“This change has the potential of sending hundreds of millions of American taxpayer dollars to businesses overseas,” SBTC Executive Director Jere Glover wrote in letters to Congress and President Barack Obama. “Products developed and manufactured by foreign firms with U.S. tax dollars are likely to benefit their own countries, to the detriment of American businesses.”

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Humana Inc. continues its commitment to innovation, health and well-being by partnering with Blueprint Health and working together to spark change and make a meaningful impact on the health care community.

As the exclusive health insurance platinum sponsor of the summer 2012 Blueprint Health Accelerator, Humana will work closely with program participants and other health care entrepreneurs, investors, executives and innovators that serve as mentors to the community. Blueprint Health kicked off its summer session on July 16; the intensive program provides seed capital, office space, and most critically, access to a broad range of mentors with deep healthcare, start-up and technology experience.

Johns Hopkins University

Johns Hopkins University and 11 other universities are teaming up with a for-profit company founded by two Stanford University computer science professors to offer free Internet courses worldwide, the Wall Street Journal reported Tuesday.

The schools joined four others already working with Coursera, a for-profit education technology company, which will offer over 100 online courses beginning this fall, the WSJ reported.

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MedImmune, the global biologics arm of AstraZeneca PLC, announced that it is restructuring its infectious disease and vaccines research, development and operations.  This will result in the closure of MedImmune’s Mountain View, CA and Santa Clara, CA sites, and consolidation of its infectious disease and vaccines research and development activities to other existing sites.  The changes are expected to be completed in 2014 to allow for a seamless transition of ongoing activities.

MedImmune’s Hayward, CA site will remain open with additional capabilities invested in the site.

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The 2012 NVCA Yearbook includes a comprehensive analysis of U.S. venture capital industry statistics. The main source of data for this publication is ThomsonONE.com, the online research database of Thomson Reuters. ThomsonONE.com  is endorsed by the NVCA as the official United States venture capital activity database. The publication includes metrics regarding commitments made to venture capital funds, venture capital investments into entrepreneurial companies, and venture-backed exits (mergers and acquisitions and IPOs). The publication also includes appendices regarding portfolio company valuation guidelines, international accounting convergence and venture capital activity outside the United States.

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The Greater Washington Board of Trade is forming a joint task force with the Greater Baltimore Committee and the Economic Alliance of Greater Baltimore to promote the region as a global hotbed for the cybersecurity industry.

The Baltimore-Washington Cyber Task Force plans to work with both public and private sector groups to develop a strategy for cyber industry growth around the new U.S. Cyber Command at the Army's Fort Meade, located halfway between Washington and Baltimore.

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US regulators took a step into the unknown this week when they approved the first drug to prevent HIV infection. US Food and Drug Administration (FDA) commissioner Margaret Hamburg hailed the pill, Truvada, as a tool for reducing the rate of infection in the United States, where 50,000 people are diagnosed each year. But the drug combines low doses of two anti­retroviral agents normally used to treat infection, and some researchers fear that its use in healthy people could have unacceptable side effects and spark the emergence of resistant viruses.

US insurers must now decide whether they will pay for Truvada, which costs roughly US$10,000 for a year’s supply. Moreover, health-policy experts must script guidelines on how to prescribe it, and how to monitor side effects and HIV infections in people using the drug. “There are a lot of questions about how to implement it,” says Connie Celum, an HIV researcher at the University of Washington in Seattle, who led a large trial of the drug in East Africa and has begun studies to answer practical delivery questions, such as which subsets of people are at highest risk.

DHHS

Secretary of Health and Human Services Kathleen Sebelius joined First Lady Michelle Obama and local officials from across the country to announce the next chapter in the Let’s Move! Cities, Towns, and Counties program, which encourages local elected officials to focus on improving the health of their communities.

Secretary Sebelius announced five goals for local officials to achieve within the next year to address obesity and help communities be healthier. These goals align with Let’s Move!’s five basic pillars.

“Make no mistake, childhood obesity is a national problem and demands everyone’s attention.  But it’s a problem that can’t be solved just at the national level.   We can make a significant impact, city by city, town by town, county by county,” Secretary Sebelius said.

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The current US healthcare system suffers from excessive bureaucracy and red tape-ism. Regulations have only made the care delivery process more complex with unnecessary delays and loss of productivity. The proposed shift to Electronic Medical Records (EMRs) was an attempt to bolster efficient practice methods that enable quality care delivery. Paper health records have long since become obsolete. Paper based documentation simply cannot match the growing requirements of our healthcare system. Inherent limitations along with system inefficiencies drive the costs up, whereas outcomes are far from satisfactory. Nearly 98,000 deaths are reported each year due to negligence and medical malpractice, thus medical errors are a huge cause for concern.

Before the CMS introduced the EMR stimulus program, it had turned its attention towards medical prescribing. Medication errors cause over 7,000 fatalities each year, hence it was imperative for the government to move towards a more efficient system in e-prescribing (eRx). ’It’s unfortunate but most of the medication errors are attributable to illegibility of the prescription note or miss spellings on the part of the provider’, says a pharmacologist. E-Prescribing reduces medication errors whilst improving accuracy and accountability.

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Maryland was recently named the top state in the nation for entrepreneurship and innovation. The state has the second highest concentration of STEM employment and adds STEM jobs faster than all but five other states.

With Maryland’s commitment to growth in science, technology, engineering and math, UMBC continues to develop and expand its professional programs to meet the needs of the state’s STEM-centric workforce.

The purpose of this funding opportunity (FOA) is to improve hearing health care outcomes and reduce health disparities through the development and commercialization of improved devices for hearing health care (HHC).  For the purposes of this FOA, “hearing health care” is defined as assessment and access to hearing aids and nonmedical treatment, including hearing screening and hearing assessment as well as acquiring an appropriate device and services for the individual’s hearing loss and communication needs.  Appropriate technologies must have the following basic characteristics: easily affordable, effective, culturally acceptable, and accessible to those who need them. 

This announcement calls for applications to develop devices and other technologies that address the HHC needs of the nation, including health disparity populations.  Generally, health disparity populations include racial and ethnic minorities, the rural and urban poor, and other medically underserved populations.

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A strange thing has happened during an otherwise bleak time for biotech venture capital. Life science venture capitalists are apparently hitting more of their investments out of the park.

There were 17 so-called “Big Exits” for investors in privately held biotech companies, and 18 in the medical device business in 2011, the most of any year since 2005 in a new set of data analyzed by Silicon Valley Bank. For this analysis, a “Big Exit” was counted each time a venture-backed life sciences company was acquired, and the up-front payment was worth at least $75 million. Although many of these “Big Exit” acquisitions are structured to include milestone payments that can make the deals more lucrative over time, those future payments often don’t materialize, and they weren’t factored in to the SVB analysis of investment returns.

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Science Applications International Corp.'s $473 million acquisition of maxIT Healthcare Holdings Inc. will more than double the company's commercial health care business and make good on a two-year strategy to expand SAIC's presence in that market, company executives told Washington Business Journal Wednesday.

The deal, announced Tuesday evening and expected to close in August, will create a health care business worth just north of $850 million and add about 1,300 employees to the SAIC workforce. Westfield, Ind.-based maxIT will function as a wholly owned subsidiary, with no layoffs planned and additional hires anticipated.

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Health benefits and health care company Humana Inc. has agreed to sponsor Blueprint Health, a New York City-based business accelerator for entrepreneurs in the health care and well-being industry.

According to a news release, Louisville-based Humana will be the exclusive health insurance platinum sponsor of the summer 2012 Blueprint Health Accelerator. Terms of the sponsorship were not disclosed.

NIH Careers

The NIH is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visit NIH Overview.

As part of the National Institutes of Health (NIH) mission to support biomedical research and reduce the burden of illness worldwide, the NIH Roadmap Initiative outlines the need to position the NIH to address the evolving public health challenges of the 21st Century and to enhance public-private partnerships. To support this mission, the NIH Office of Technology Transfer (OTT) is working to address global health challenges by facilitating the transfer of technologies to people around the world.

Human Genome

U.K. drug maker GlaxoSmithKline said Monday it had secured its takeover of Rockville-based Human Genome Sciences after agreeing to pay a higher price for the U.S. biotechnology company.

In a joint announcement by the two companies, GSK said it would pay $14.25 per share for Human Genome Sciences, up from its previous offer of $13 per share. The offer values Human Genome Sciences at $3.6 billion.

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GlaxoSmithKline of Britain is near a deal to buy the biopharmaceutical company Human Genome Sciences on friendly terms for about $2.8 billion, potentially ending a long hostile takeover campaign, a person briefed on the matter said on Sunday.

Under the new terms of the deal, GlaxoSmithKline would pay about $14 a share in cash, this person said.

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.

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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."

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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

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.

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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.

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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.

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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.

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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.

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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.

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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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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.