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GlaxoSmithKline and Theravance get FDA Clearance for Lung Disease Drug

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By Eve Green

Partner companies Theravance and the GlaxoSmithKline have received Food and Drug Administration clearance for their new drug for the treatment of COPD, Breo Ellipta. COPD encompasses what used to be known as emphysema and chronic bronchitis – the new drug should be an improvement on current treatment options which can ease the symptoms of this disease. COPD, which is strongly linked to smoking, is the third most significant cause of death in America.

Curtis Rosebraugh, director of FDA Office of Drug Evaluation II, commented that this new long-term maintenance treatment for COPD will provide new care options for the millions of people in the USA who suffer from the condition. The companies have stated that the drug should be available during the third quarter of 2013. Breo Ellipta, which requires a single dose per day, should surpass existing treatments which require two doses.

COPD

COPD stands for chronic obstructive pulmonary disease, a progressive condition (one which continually worsens) which causes breathing problems in those who suffer from it. The symptoms are coughing and the associated overproduction of mucus, shortness of breath especially during exercise and tightness of chest. COPD is also associated with a greater susceptibility to chest-infections. Doctors used to refer to ’emphysema’ and ‘chronic bronchitis’, though these are now officially grouped under this general condition. 

A disease which is currently under-diagnosed, this condition refers to the inflammation and subsequent damage to the interior of the lungs, and results in lower efficiency in taking on oxygen and in problems with the mechanics of breathing. Smoking is the top cause of COPD, though a genetic predisposition can cause it in some people. While the damage which it causes cannot be repaired, sufferers who subsequently quit smoking can slow down the progress of the disease. 

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Park, Sebelius Tout Federal Initiatives’ Effect on Health IT – iHealthBeat

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This week, U.S. Chief Technology Officer Todd Park and HHS Secretary Kathleen Sebelius posted separate entries on the White House Blog touting the effect of federal initiatives on health IT adoption and health industry innovation, FierceHealthIT reports.

The posts were written in response to a New York Times commentary published by columnist Thomas Friedman last week about health industry innovation related to the Affordable Care Act and other federal initiatives.

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Washington, Baltimore collaborate on regional cyber job growth – Washington Business Journal

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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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New ‘Out of This World’ Space Stethoscope Valuable Here on Earth, Too – The Johns Hopkins University

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A team of students at the Johns Hopkins University’s Whiting School of Engineering has designed for NASA a new stethoscope that delivers accurate heart- and body-sounds to medics who are trying to assess astronauts’ health on long missions in noisy spacecraft.

Space is serene, because no air means no sound. But inside the average spacecraft, with its whirring fans, humming computers and buzzing instruments, is about as raucous as a party filled with laughing, talking people.

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React Labs Awarded $100K in Maryland Innovation Initiative Funding – Baltimore Business Journal

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React Labs, an early stage company commercializing a comprehensive mobile technology platform for real-time polling, has been awarded $100,000 in funding from the Maryland Innovation Initiative (MII), company officials announce today.

Founded by University of Maryland Professor Philip Resnik, who holds joint appointments in the Department of Linguistics and at the Institute for Advanced Computer Studies (UMIACS), React Labs offers a mobile application that allows a very large numbers of participants to register their moment-by-moment reactions to live and televised events, providing a highly engaging user experience and producing rich, detailed data for analysis.

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Cybersecurity Master’s at UMBC Shady Grove – Virtual Info Session Held June 19 – Press Release – Digital Journal

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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.

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Aspiring Giants: How Emerging Life Science and Biotech Companies Can Grow to $1 Billion and Beyond

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Please join us for an exclusive, invitation-only event to be held in conjunction with PwC and the Technology Council of Maryland.

This event has been designed especially with you in mind. You’ll have the opportunity to network with your peers in an intimate setting and learn what it took companies within your industry to grow and become $1 billion market leaders. Presenter Brian Williams is a successful life sciences entrepreneur. Now consulting for PwC, Brian will present a roadmap other life science companies have followed to experience explosive growth in a dynamic and demanding environment.

Amid the volatile blend of opportunity and challenge that characterize the global life sciences industry, only a few small companies have managed to catapult their revenue over the $1 billion mark over the past two decades. Whether they chose to expand their focus and product portfolios, enter new geographies, or grow their core business, these aspiring giants pursued three distinct strategies to jump start growth:

  • Leveraging core product/technology capabilities to launch differentiated products
  • Using mergers & acquisitions and partnerships to gain new products and/or expand geographic presence
  • Building a strong, stable leadership team armed with a compelling vision and relentless drive

We hope you can join us to explore these topics and discuss their applicability to you and your company.

When:
Tuesday, June 11, 2013

Time:
8:00 – 8:30 am – Registration and networking
8:30 – 10:30 am – Program

Location: The Universities at Shady Grove Conference Center
9630 Gudelsky Drive
Building II, Room 11-1042
Rockville, Maryland

If you have any questions regarding the event, please Deana Mary at deana.mary@us.pwc.com or 703.918.3631<

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NEA Scores Two IPOs in a Week – peHub

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It’s tough to move the needle on a multi-billion-dollar venture fund. That’s one reason New Enterprise Associates, which has managed mega-funds about as long as anyone in the business, makes a habit of taking large stakes in portfolio companies.

That strategy can pay off well in the event of a big exit – which is what happened last week with the IPO of data analysis provider Tableau Software. NEA, a backer in all of Tableau’s venture funding rounds, was the largest shareholder at the time of the offering. And as Tableau shares soared post-debut, NEA’s stake did as well. The firm sold 1 million shares in the offering for $31 million, and its remaining 18.6 million shares were worth more than $900 million as of last week.

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QIAGEN and China’s BioBAY open translational medicine center to accelerate creation of novel companion diagnostics

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QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and SIP Biotech Development Co., Ltd. (BioBAY) today announced the opening of QIAGEN (Suzhou) Translational Medicine Center, a translational medicine R&D Corporation which aims to accelerate the discovery and validation of biomarkers, and to create companion diagnostics for the Chinese market. QIAGEN (Suzhou) is a joint venture of QIAGEN and BioBAY, the innovative life sciences cluster in Suzhou Industrial Park near Shanghai. The companies announced the launch of QIAGEN (Suzhou) today in an opening ceremony on the BioBAY campus, which currently hosts more than 330 companies and research groups.

QIAGEN (Suzhou) will provide services and consulting with state-of-the-art QIAGEN molecular technologies for international and Chinese pharmaceutical companies, as well as research institutes to enable translational medicine, the multidisciplinary process of advancing discoveries from laboratory bench to the patient’s bedside. The center will work with partners located at BioBAY and elsewhere in China to provide fully integrated biomarker solutions to accelerate drug development, as well as to commercialize companion diagnostics. The four key service sections include biobanking, pharmacogenetics, next generation sequencing (NGS) and pharmacogenomics. This innovative alliance builds on QIAGEN’s leading global position in Personalized Healthcare, using genomic information to produce individualized treatment decisions for patients. QIAGEN (Suzhou) is expected to grow to about 50 employees within three years.

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