Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
Pharmaceuticals
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The […]
Alcon to pay $60M to acquire Kala Pharmaceuticals’ dry eye treatment
Alcon (NYSE:ACL) announced today that it agreed to acquire Eysuvis pharmaceutical eye drops from Kala Pharmaceuticals. Geneva, Switzerland-based Alcon will pay $60 million upfront to Kala for the dry eye treatment. As part of the agreement, the company will also acquire Kala’s Inveltys corticosteroid for twice-per-day treatment of post-operative inflammation and pain following ocular surgery. […]
BD, Mitsubishi Gas Chemical partner on better materials for plastic syringes
BD (NYSE:BDX) announced that it partnered with Mitsubishi Gas Chemical Company on applying new technology to pre-fillable syringes. MGC develops the Oxycapt technology designed to integrate the best of plastic and glass for plastic syringes. BD and Tokyo-based MGC will work together to apply Oxycapt technology to the next generation of pre-fillable syringes (PFS) for […]
ApiJect picks up $111M investment from Royalty Pharma, Jefferies
Injection delivery system developer ApiJect announced today that it completed a private investment round worth $111 million. Royalty Pharma and Jefferies Financial Group led the investment round. Jefferies also acquired a revenue interest in addition to equity through the financing. According to a news release, the investment round values ApiJect at approximately $300 million. Jefferies […]
Here’s what’s next for Insulet after the launch of Omnipod 5, CEO change
The future for Insulet (Nasdaq:PODD) has a different look than it did about a week ago. A massive shake-up at the executive level came on May 5 when Shacey Petrovic announced she would step down as president and CEO for personal reasons. Petrovic will stay on as a board member at the Acton, Massachusetts-based automated […]
Study supports use of PharmaJet’s needle-free vaccine delivery systems
PharmaJet announced today that study data demonstrated increased immunogenicity when using its needle-free delivery system. Golden, Colorado-based PharmaJet presented the research results for the needle-free vaccine injection technology last week at the World Vaccine Congress. PharmaJet’s needle-free systems have been incorporated into clinical studies for multiple RNA and DNA vaccine and therapeutic development programs thanks […]
Impel NeuroPharma rebrands to Impel Pharmaceuticals as part of corporate transformation
Impel NeuroPharma (Nasdaq:IMPL) announced today that it changed its name to Impel Pharmaceuticals as part of a corporate rebrand. Seattle-based Impel develops proprietary Precision Olfactory Delivery (POD) technology to treat patients suffering from diseases across a range of areas in addition to the central nervous system. The company’s Trudhesa nasal spray for treating migraine in […]
EMA gives positive opinion on Novo Nordisk’s human insulin with flexible storage
Novo Nordisk (NYSE:NVO) announced that the European Medicines Agency (EMA) granted a positive opinion on a storage update for insulin. EMA’s positive opinion relates to a proposed update to the storage conditions of two human insulins: Actrapid (short-acting insulin) and Insulatard (intermediate-acting insulin). Bagsværd, Denmark-based Novo Nordisk said in a news release that the EMA’s […]
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics
It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]