Friday, September 11, 2015

This week in ePharma: The FDA is sued again over off-label marketing | BREAKING: 3D-printed rib cage saves a life

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The FDA is sued by Pacira over the off-label marketing rights.The FDA agency is being sued again over pharmaceutical marketing practices. Looks like the last month's precedent laid a cornerstone in the confrontation between the FDA and drugmakers in which the latter have a much higher chance to win the argument. Using The First Amendment "Freedom of Speech", the drugmaker Pacira Pharmaceuticals Inc. is taking the government agency to court to secure the rights to promote Pacira's pain drug Exparel.

As a reminder, last month the U.S. District Court for the Southern District of New York granted the First Amendment protection for truthful and non-misleading off-label promotion.

The first patient just got enrolled into the Biogen Phase-III clinical trial for its Alzheimer's disease treatment aducanumab. This is the second time the Alzheimer's / Parkinson's disease cure research is making the news this month. The Phase-III program is planning to study 2,700 patients in the early-stage of Alzheimer's disease. Previously, Biogen's Phase 1b study showed small-scale but positive results in slowing cognitive decline in patients with mild or preexistent Alzheimer's.
A man from Spain got a surgery implanting 3D-printed rib cage and sternum into his body.

The first of its kind surgery involving 3D-printed body parts was performed on a man from Spain. Due to the cancer complications the patient had to have removed a part of his rib cage and a sternum. The surgical team from Salamanca University Hospital in Salamanca, Spainhas ordered a customized 3D-printed titanium implants.  

This is the second breakthrough surgery involving 3D-printed body parts that's revolutionizing modern medicine.
Walgreens Pharmacy talks digital health and telemedicine
In his recent interview with the Health Business Blog, the VP of Digital Health, Walgreens, Adam Pellegrini answered a few questions around Walgreens' involvement with digital health and telemedicine trends.

Specifically, Mr. Pellegrini mentioned the Balance Rewards for Healthy Choices program, an initiative that was recently integrated into the strategy of the company. Through this program customers can collect points for healthy actions and not for purchases. For example, users can get points for walking or quitting smoking.

Another important question that Mr. Pellegrini answered was about the role of a pharmacist in telehealth for Walgreens. Telehealth as defined by Health Resources and Services Administration, "is the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration."

In his statement, the VP of Digital Health, Walgreens stated that he hopes telemedicine will enable and extend an area of medication management. It will be used to answer simple questions about medication. And as a good example, Pellegrini brought up the pharmacy's chat adding that they conduct

9,000 - 10,000 health chats weekly with Walgreens' customers. "That's free for everyone. If we can walk inside of a pharmacy and ask a question, we should be able to do this digitally as well," - concluded A. Pellegrini.

Stay tuned for our weekly news round up!

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About the author: Ksenia Newton, a Digital Marketing Assistant at IIR USA, Pharma Division, who works on various aspects of the industry including social media, marketing analysis and media. She can be reached at knewton@iirusa.com
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