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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Science & Medicine
Cardio Brief | Sep 9, 2016
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FDA Delays Approval of Xarelto Reversal Agent

Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter from the FDA regarding its Biologics License Application for AndexXa.It is unclear how long it will take Portola to respond to the FDA’s and gain approval. The Portola press release does not appear to suggest that the FDA has raised a major or insurmountable obstacle to approval.

Science & Medicine
Fierce Pharma | Sep 9, 2016

Report: Sharp Increase in Mylan Ad Spend Coincided with EpiPen Price Hike

It’s no secret that Mylan poured millions into a new ad campaign as it hiked the price of its EpiPen anaphylaxis auto-injectors. But new data shows Mylan was pumping up search engine spending at the same time.

Science & Medicine
Claims Journal | Sep 8, 2016
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Insurance Company Warns Against Pokemon “Catch and Drive”

Esurance, an Allstate company, caused a bit of a scene. The home and auto insurer staged a fender bender to encourage safe driving, an important message to address the recent series of car accidents caused by people playing mobile games while driving.

Science & Medicine
Cardiovascular Business | Aug 30, 2016

Can St. Jude Medical Devices be Hacked?

Carson Block, founder of Muddy Waters LLC, wrote a 33-page report to investors warning that St. Jude’s pacemakers and defibrillators could be susceptible to hacking, according to a Bloomberg article

Science & Medicine
Forbes | Aug 30, 2016

Mylan Myopia: EpiPen Prices and CEO Compensation

When you have a disease that you can’t cure, the next best thing is to treat the symptoms. Mylan is a symptom.

Science & Medicine
Forbes | Aug 23, 2016
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Lack of Clinical Trial Transparency a Problem for BigPharma

When Big Pharma doesn't fully disclose the results of all its clinical trials, both the industry and patients suffer consequences, says one bioethics expert.

Science & Medicine
Health Care Renewal | Aug 15, 2016

Conflict of Interest Question Raised for Brookings Scholar Who Sits on J&J Board

Johnson and Johnson Board Member Pretends to be Independent Brookings Institution Scholar Fears that "the system is rigged" may cause the lack of trust marring this year's political season. These fears are not baseless.

Science & Medicine
Aug 8, 2016

E-Cig Explosion Risk Prompts Warning for Truckers

The Federal Motor Carrier Safety Administration (FMCSA) is warning drivers of commercial motor vehicles about explosions, serious personal injuries and fires that occur with battery-powered portable electronic smoking devices

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