OncoSec Medical (NSDQ:ONCS) and Inovio Pharmaceuticals (NSDQ:INO) announced that they are testing potential COVID-19 vaccines after the latter received investigational new drug clearance from the FDA. Inovio received an IND nod, while OncoSec’s is pending, but both companies are pursuing a first-in-human Phase 1 clinical trial for their vaccines, according to separate news releases. OncoSec is using […]
Medtronic adds AI-fueled Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation […]
Leo Pharma, Portal Instruments partner to develop needle-free drug delivery device
Leo Pharma and Portal Instruments this week announced a global collaboration and license agreement to develop a needle-free drug delivery system. Through the agreement, Leo Pharma’s investigational and approved medicines will be used in combination with Portal’s needle-free drug delivery system. Portal’s needle-free jet injector platform allows patients to self-administer biologics without needles. It features […]
‘Hubble Space Telescope’ for genomics could yield new drugs, materials
Researchers in Spain have developed a new genomics tool that can classify how species are related to each other at far larger scales than previously possible and may yield new drugs, materials and foods — and pinpoint strategies for saving species at risk of extinction. Heralded as a “Hubble Space Telescope” of genomics, the technology […]
How human factors created a new generation of drug delivery devices
Human factor testing is beneficial early on in the design process, rather than as a confirmation at the end. Here’s how testing for usability and desirability helped spark three generations of drug delivery devices. West Pharmaceutical Services has multiple generations of its SmartDose products under its belt since it started working on the drug delivery […]
Tusker Medical’s pediatric ear tubes land breakthrough device designation
The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
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