Patients undergoing transcatheter aortic valve implant may need a pacemaker after the TAVR device, but a new study suggests that right bundle branch block may predict the need for pacing. The data may have implications for device selection as some devices are seen as less likely to trigger the need for a pacemaker, a development that may move the needle in the robust but increasingly competitive market for TAVR.
Virta Health Corp. reported 90-day data from a pilot study of its Virta Treatment for type 2 diabetes (T2D) in military veterans. Conducted jointly by Virta and the U.S. Department of Veterans Affairs (VA), the pilot shows 84% of participants who used the low carbohydrate and diabetes coaching model reduced their glycemic levels to below the diabetes threshold or experienced at least a one-point drop in HbA1c, a measure of blood sugar.
The Alfred Mann Foundation (AMF) and Össur have signed an agreement that will allow Reykjavik, Iceland-based Össur to further develop and license the implanted myoelectric sensor (IMES) system developed by AMF. Both organizations expect clinical trials to begin within the year.
Diabetes management company Dexcom Inc. trounced Wall Street forecasts for the third quarter of 2019, with the company reporting worldwide sales of $396.3 million, up 49% from $266.7 million in the same period of 2018. Dexcom officials attributed the surge to volume growth plus new patient additions as providers and consumers become more aware of the benefits of real-time continuous glucose monitoring (CGM), where Dexcom's G6 has seen steady demand since launching in June 2018.
Bowing to congressional pressure, the U.S. Department of Health and Human Services (HHS) Wednesday filed suit against Gilead Sciences Inc. for infringing government patents related to the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis (PrEP).
Whether prescription drug prices are skyrocketing in the U.S. is a question of perspective and context. Patients needing regular refills of insulin or certain other brand drugs with no generics are seeing their out-of-pocket costs going up, sometimes with every trip to the pharmacy.
Those cheap prescription drug prices other countries get? They're not always the result of savvy government negotiations. An antitrust suit the U.S. Court of Appeals for the Second Circuit dismissed Tuesday alleges that some of those low prices may be innovator shenanigans intended to prevent or delay biosimilar competition in the U.S. market.
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner.
Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
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