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FDA Accepts Emergent BioSolutions’ Supplemental Biologics License Application for Large-Scale Manufacturing of BioThrax in Building 55

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Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.

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Predicting Contagiousness to Limit the Spread of Disease

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Imagine the workplace during flu season. Some people get sick and display clear symptoms—a warning sign to coworkers to avoid contact and for that individual to stay home. Others are infected, but never or only belatedly exhibit the tell-tale signs of sickness, meaning they can infect coworkers without knowing it. If healthcare professionals had the ability to test in advance whether a person is likely to spread a disease following infection, they could recommend specific measures to treat the person or limit exposure and perhaps keep an outbreak from growing into an epidemic or pandemic.

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Biotech is booming – Cambridge News

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The UK biotechnology sector continues to build on the success of previous years, raising an unprecedented £900m on the London Stock Exchange in 2015 and recording the highest level of venture finance in recent years, according to the latest report Money, momentum and maturity: UK biotech financing and deals in 2015/16 compiled by the UK BioIndustry Association (BIA) in partnership with Evaluate and the London Stock Exchange.

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Do cities need a point-person to lead innovation?

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As cities continue to invest more in smart city technologies, questions surrounding how to staff those moves can puzzle city leaders.

Martin O’Malley, the former mayor of Baltimore and governor of Maryland, suggested during remarks at the Smart Cities Innovation Summit that during his leadership — both at the city and state levels — having a chief innovation officer close to the executive was key to driving government away from the status quo and into new possibilities.

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Emergent BioSolutions: Underlying Value To Be Realized Following Aptevo Spin-Off – Seeking Alpha

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Emergent BioSolutions Inc. is a global specialty pharmaceutical company, which offers specialized products to governments and healthcare providers. The company derives most of its revenue from one product, BioThrax, which is the only FDA-licensed vaccine for the prevention of anthrax disease. In 2015, about 56% of the company’s revenue came from the sale of BioThrax with the remainder coming from the sale of their other biodefense products, biosciences products, and contract manufacturing.

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Alexandria Real Estate Equities launches co-working for science guys – Real Estate Weekly

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Alexandria Real Estate Equities, the owner and developer of the Alexandria Center for Life Science on the East Side of Manhattan, has just launched an incubator space for biotech start-ups.

The new life science laboratory and office platform, which will be called Alexandria Launchlabs, promises 15,000 s/f of space that provides “the necessary resources and collaborative environment to start transforming novel ideas into innovative, early-stage companies that develop products to improve human health.”

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Career Opportunity: Chief Executive Officer, TEDCO

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POSITION TITLE: Chief Executive Officer

REPORTING TO: Board of Directors

THE COMPANY: TEDCO (Maryland Technology Development Corporation)

“The economic contribution to the Maryland economy of TEDCO’s five core research, technology transfer, and commercialization programs totaled almost $1 billion in 2015, generating a total of 4,358 jobs” – Battelle Technology Partnership Practice, Report on Economic Impacts of TEDCO

TEDCO was created by the Maryland State Legislature in 1998 to facilitate the transfer and commercialization of technology from Maryland’s research universities and federal labs into the marketplace and to assist in the creation and growth of technology-based businesses in all regions of the State. TEDCO is an independent organization that strives to be Maryland’s lead source for entrepreneurial business assistance and seed funding for the development of start-up companies in Maryland’s innovation economy. In Maryland and beyond, TEDCO is a resource of mentoring, funding and networking for entrepreneurs and start-ups that need guidance as they bring innovative concepts to market. TEDCO is more than an early stage funding resource. It is the hub of Maryland’s entrepreneurial network where start-ups find mentors, organizational assistance, facilities for daily operations, and a roadmap for success.

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UN Access to Medicines Panel Undermines Bayh-Dole  – IPWatchdog.com

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Global epidemics are outrunning globally accessible containment and cures. There are now more ways to spread diseases worldwide than safe, effective ways to counter them. Biomedical stakeholders are engaged in finding solutions. Now rumored recommendations pending at a UN High Level Panel may make matters worse. Appointed by outgoing Secretary General Ban Ki-Moon, the Panel is said to be preparing to release its examination of world  “Access to Medicines”.  Amazingly it is rumored to be encouraging international flouting of U.S. Bayh-Dole-based patent protection and producer pricing prerogatives. This inevitably will undermine our nation’s life science innovation ecosystem, effectively destroying world hopes for effective response to evolving epidemics.

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