
The U.S. Food and Drug Administration on Monday issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease’s spread.

The U.S. Food and Drug Administration on Monday issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease’s spread.

Thomas Luginbill knows what it takes to be a successful entrepreneur. He spearheaded the founding of a campus organization when he was an undergraduate, helped start a family-run contracting business and co-created a start-up technology venture while studying for an MBA. This self-described “serial entrepreneur” has been named as director of the College of Southern Maryland’s newly formed Entrepreneur and Innovation Institute (EII).

AstraZeneca announced it will sell the full commercialization and development rights of its late-stage small molecule antibiotics business to Pfizer, while AstraZeneca focuses on developing therapies for other main areas, according to a press release.

Johns Hopkins Medicine has launched the Johns Hopkins Wilmer Zika Center, where medical professionals focus on caring for patients with the Zika virus. The center is touted as the first multidisciplinary Zika center in the world.

Life sciences investor Sofinnova Ventures is raising fund number 10 in what, as FierceBiotech notes, appears to be its largest fund to date. A previous fund, dating back to 2014, raised $500 million.

While driving and listening to National Public Radio one day, Justin Kao heard about the discovery of a “sweet tooth gene” that makes you more likely to crave sweets. “Oh my God,” thought Kao, who has always loved cookies. “I would pay $5 to know if I had that.”

Today’s medicines can cost hundreds of thousands of dollars a year. The story of how two companies set prices for their costly new drugs suggests that the way we determine the value of such treatments will help decide the future of our health-care system.

Phil Magrogan, PMP, SCP4, ITIL Senior Program Manager Leidos
Agile represents a widely adopted set of principles that apply to small scale teams – typically 7 to 9 developers. Several authors have published frameworks, techniques, and methods for applying agile principles to large organizations – over 100 developers. Now that we have a few years of experience in applying agile to large scale organizations it is time to look back at what works and what doesn’t work so that large organizations can leverage good practices and avoid pitfalls performing with agile at scale.
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Pharmaceutical giant AstraZeneca’s agreement to sell much of its antibiotics business won’t impact operations at MedImmune, its Gaithersburg-based research and development arm, officials confirmed Wednesday.

Before we start, long time readers know, we have no interest in trying to influence your political views or voting allegiance (not that we could). So please don’t look for “hidden meanings” or agendas. If we have something to convey, we will come right out and say it.
We could have done several SBIR Insiders over the eight weeks, but none of them would have had much value because every time I thought we had something important to report, the story would change and the relevance of the Insider issue would have been moot.