CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.
Last week ended with another Friday night blitz of biotech S-1s as a fresh wave of new offerings forms to crash into Nasdaq. Entering the Wall Street spotlight now is one transatlantic operation that is out to develop a new class of meds, a Dallas biotech with a Phase III kidney cancer drug and a startup that in-licensed its lead drug from Novartis.
Canada’s top universities and research institutes spent $5.7 billion on research and development (R&D), but generated less than $75 million from licensing their innovations in 2017. That’s an average return on investment of 1.3 per cent, according to the latest report from AUTM, which monitors commercialization from academic research in Canada. Institutions filed 687 patents, down from 790 in 2016 and the fewest since 2008.
Redox, a Madison, Wisconsin-based healthcare technology company that is transforming the way healthcare providers and software vendors share data, announced it has raised $33 million in Series C funding led by Battery Ventures. Also participating in this round is .406 Ventures, RRE Ventures, and Intermountain Ventures. In conjunction with this funding round, Battery general partner Chelsea Stoner is joining Redox’s board.
The startup incubator Y Combinator plans to fund more early-stage drug makers, with a partnership designed to bring academic spinouts developing small-molecule drugs into its famed accelerator program. And in a Silicon Valley twist, the compounds it’s backing will often be recommended by an algorithm.
United Therapeutics Corporation (Nasdaq: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS™ and STEEN Solution™. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.
GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.
Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.
A pioneering medical breakthrough that will help organ transplant recipients was announced by the University of Maryland Medical School.
Drone technology was developed by the University’s School of Medicine and Engineering to transport donor organs. The LG-1,000 is the first-ever organ delivery drone and weighs 50 lbs.
With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.
