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FDA Finalizes Guidance on Radio Frequency Wireless Technology – iHealthBeat

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This week, FDA issued final guidance on incorporating and integrating radio frequency wireless technology into medical devices, Bloomberg BNA reports.

In a blog post on Tuesday, FDA Senior Policy Adviser Bakul Patel wrote, “Our goal is to help industry develop a range of innovative, safe and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality and benefit patients and providers alike” (Weixel, Bloomberg BNA, 8/14).

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Biotech VCs, Stung by Startup Returns, Elbow into Royalty Financing | Xconomy

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The new landscape for venture capital investing does not seem to leave much room for classic company formation. Investor after investor has shut down or moved beyond startups into what seem like greener pastures.

So it should come as no surprise that at least a few VC firms are now expanding into the royalty space, as shown by a deal announced this week. Aisling Capital and Clarus Ventures, two top-tier VC firms, acquired 20 percent of the royalty stream created by sales of ibrutinib, a novel tyrosine kinase inhibitor developed by Pharmacyclics (NASDAQ: PCYC) and partnered with Johnson & Johnson (NYSE: JNJ) for use in B-cell malignancies such as chronic lymphocytic leukemia (CLL).

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Chinese Center for Disease Control and Prevention and Aeras Sign Agreement to Collaborate on Tuberculosis Vaccine R&D

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With the global tuberculosis epidemic becoming more deadly, costly, and difficult to treat, Chinese Center for Disease Control and Prevention (China CDC) and Aeras today signed a memorandum of understanding to advance research and development of new tuberculosis vaccines. An improved TB vaccine offers the best hope for eliminating this airborne infectious disease that kills 1.4 million people worldwide each year.  

While China has achieved significant reductions in TB illness and death over the past 30 years, TB remains a major public threat, with over one million new cases in China each year. A study published in the New England Journal of Medicine last year found that one in 10 cases of TB in China are resistant to the most commonly-used drugs. Based on the World Health Organization’s estimates of global multidrug-resistant TB (MDR-TB), China has the highest annual number of cases of MDR-TB in the world—a quarter of the cases worldwide.

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A Very Wharton Health Demo Day – Entrepreneurship Blog

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DreamIt Health Demo Day has gotten a lot of great press, from Philly.com to NewsWorks to Technical.ly Philly, and many more. These plaudits are well deserved: DreamIt Health was the first Philadelphia-based health care accelerator, and by all accounts it was a huge success. Ten health care startup companies participated in this venture, made possible by a collaboration between Independence Blue Cross (IBC), Penn Medicine, and DreamIt Ventures. The more than 300 attendees to the Demo Day on July 24, 2013 included potential investors and customers, mentors, and health care executives.

We at Wharton Entrepreneurship are delighted, and not only because this event was such a terrific demonstration of the robust community of heath care entrepreneurs in the Philly region. We’re proud to point out that the founders of four of the presenting companies and both of the speakers are all Wharton Entrepreneurship alumni, several of whom went through our Venture Initiation Program (VIP)! If that’s not a demonstration of Knowledge in Action, then I don’t know what is.

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Baltimore Innovation Week 2013 – Awards

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Let’s Celebrate How Baltimore Is Innovating.

The people and organizations represented below are advancing the city in new and inspiring ways, by growing businesses, increasing regional economic activity, publishing high-quality works of media, creating new gateways to the technology community and much, much more. They’re the best of the best in this community. This is the Baltimore region’s only people’s choice award for technology, entrepreneurship and new thinking.

Winners will be determined by online voting counts. Voting closes on Friday, September 13th. Awards will be announced at the Baltimore Innovation Week week closing party on Fri. Sept. 27.

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French Man with SynCardia Total Artificial Heart Surpasses Two Years of Support – 2013 Press Releases – SynCardia Systems, Inc.

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Due to the global shortage of donor hearts, patients on the waiting list for a heart transplant can wait several months to several years for a match to be found. But for 36-year-old Frédéric Thiollet, who surpassed two years of support with the SynCardia temporary Total Artificial Heart on Aug. 5, he’s enjoying each and every day.

“I feel well and I am confident, having been implanted now for over two years,” said Frédéric Thiollet. “I have recuperated all my physical functions, even my sexual activity, which I had believed was gone forever. In my own words, I have enjoyed an effective resurrection, a new birth. Physically I have no limit. I am as strong and powerful as before, even more so than before.”

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UM ranked 13th greenest by Sierra – baltimoresun.com

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The University of Maryland College Park, which likes to tout itself as a leading public research institution, has added a little more green to its laurels.

Sierra Magazine ranks the state’s flagship campus as the 13th greenest university in its latest national rating of “Cool Schools.”

UM trailed the University of Connecticut, Dickinson College, Stanford and American universities, among others, while besting the likes of Harvard, Yale and the University of California, Berkeley.

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GlaxoSmithKline JV wins FDA OK on HIV blockbuster dolutegravir – FierceBiotech

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The FDA has stamped an OK on GlaxoSmithKline’s HIV drug dolutegravir–to be sold as Tivicay. The approval marks another key advance for Glaxo ($GSK) on the regulatory front this year, providing a blockbuster candidate that analysts believe should do very well in competing against Gilead’s ($GILD) rival therapies.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a release. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”

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