Wanted: FDA App Enforcement
I need help figuring this out. A pretty innovative guy named Myshkin Ingawale of Biosense Technologies, Mumbai, India two weeks ago stood in front of the audience at TED (Technology, Education and Design) in Los Angeles and announced that he was introducing through Apple’s App Store an app that lets you test your urine. It got quite a bit of attention among the blogs with plenty of jokes about having to pee on your iPhone. More>>
New medical technology draws on nature for inspiration
Sea worms, jellyfish, geckos and spiders may seem unlikely muses to cutting-edge technology. But these creatures are helping stimulate medical innovations — including new adhesives, diagnostic tests and needles — that are slowly migrating from the lab to the clinic. More >>
The first-to-file provisions of the American Invents Act (AIA) take effect on March 16, 2013. Medical device companies have much at stake and are taking precautions now to prepare for this significant change in America’s patent system. Under the first-to-file rules, any patent application filed after March 16, 2013 containing even a single claim with a priority date of March 16, 2013 or later will fall under the first-to-file rules. More >>
Facebook graph search: opportunity or crossing the line for pharma
Facebook’s Graph Search is a search engine that traverses the Facebook data, accessible via a box at the top of Facebook. The system allows users to make lengthy natural-language queries in search of Facebook-based information about photos, friends, and other content. For example, you could input “Friends of friends who like trail running” and receive a list of people who meet that description—provided their information is public, and they indicated to Facebook that they “Like” trail running. However marketers could also enter “people who have bipolar disorder” and target ads specifically to them. Is this an opportunity for pharma or is it crossing the privacy line ? More >>
We thought it would only be a matter of time until the Federal Trade Commission (“FTC”) decided to voice its views in a lawsuit filed last September by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in the U.S. District Court for the District of New Jersey seeking declaratory relief that Actelion is under no affirmative duty or obligation to supply prospective ANDA applicants with its brand-name drug products TRACLEER (bosentan) Tablets and ZAVESCA (miglustat) Capsules for purposes of bioequivalence testing and ANDA submission. That time has come, and just on the heels of the Counterclaim Plaintiffs’ (Apotex Corp., Roxane Laboratories, Inc., and Actavis Elizabeth LLC) opposition to Actelion’s Motion for Judgment on the Pleadings and to Dismiss Antitrust Counterclaims More >>
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