Baxter files for approval for heart pump:
This article was originally published in Clinica
The FDA has told Baxter Healthcare that it can file a premarket approval application for its implantable device, which supports the pumping area of the heart in patients with heart failure. The Novacor left ventricular assist device is implanted next to the heart and driven by an electrical pump powered by external batteries. The initial application is as a bridge to a heart transplant but Baxter thinks that the device will eventually be approved as a permanent alternative to a replacement heart. The company said that two patients in Europe have now had the device for more than three years.
You may also be interested in...
HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More
GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.
In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.
Biogen value-based contract with UPMC Health Plan ties payments to patient-reported outcomes for Tecfidera and Avonex. The company may seek something similar for Vumerity.