Vaxxas announced today the Australian government is granting it nearly $5.5 million for the manufacturing of its vaccine delivery device. Cambridge, Massachusetts-based Vaxxas picked up AU$8.2 million ($5.48 million). The second-round grant represents part of the Australian government’s Modern Manufacturing Initiative (MMI). Funding supports the manufacturing scale-up of Vaxxas’ device for applying vaccines to the […]
Study says Abbott FreeStyle Libre reduces rate of hospitalization
Abbott (NYSE:ABT) today announce real-world data demonstrating reductions in hospitalizations associated with the FreeStyle Libre system. The RELIEF study evaluated Abbott’s FreeStyle Libre continuous glucose monitoring (CGM). The findings included the significant reduction of the rate of hospitalizations due to acute diabetes events (ADEs). This study evaluated people living with type 2 diabetes on once-daily […]
Insulet wins CE Mark for Omnipod 5 for children 2 and up
Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts-based Insulet said it represents the first CE-marked tubeless hybrid closed loop system. The latest-generation Omnipod 5 […]
Advanced NanoTherapies wins FDA breakthrough nod for drug-coated balloon
Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB). Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo […]
Recall of Baxter Clearlink due to risk of leaks is Class I
The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy […]
Philip Morris hires two former FDA officials as it pushes ‘smoke-free’ development
Cigarette maker Philip Morris (NYSE:PM) announced today that it appointed two former FDA officials to leadership positions. Dr. Badrul Chowdhury is the company’s new chief life sciences officer for smoke-free products. Dr. Matthew Holman joins as VP of U.S. scientific engagement and regulatory strategy. Both appointments fall in line with the company’s efforts to push […]
Turn Biotechnologies launches delivery system for nucleic acid therapeutics
Turn Biotechnologies announced today that it created a novel platform for the safe and effective delivery of nucleic acid therapeutics. Mountain View, California-based Turn said in a news release that the platform represents a “major expansion” of its business. It designed its eTurna Platform for the next generation of precision medicine. eTurna allows for fine-tuning […]
BD launches next-gen prefillable vaccine syringe
BD (NYSE:BDX) announced today that it launched its next-generation glass prefillable syringe (PFS) for vaccine delivery. Franklin Lakes, New Jersey-based BD’s new Effivax syringe features tightened specifications for processability, cosmetics, contamination and integrity. The company designed it in collaboration with top pharmaceutical firms to meet the evolving needs of vaccine manufacturing. “As biopharmaceutical companies continue […]
FDA clears embolic microspheres from ABK Biomedical
ABK Biomedical announced today that it received FDA 510(k) clearance for its Easi-Vue embolic microspheres for treating tumors. Halifax, Nova Scotia-based ABK designed its microspheres for treating patients with arteriovenous malformations and hypervascular tumors. Vascular embolization is an effective therapy for addressing symptoms of these conditions. ABK said in a news release that microsphere embolization […]
MedAlliance enrolls first patient in study of drug-eluting balloon for treating erectile dysfunction
MedAlliance announced today that it enrolled the first patient in a trial for its drug-eluting ballon in treating erectile dysfunction. Geneva, Switzerland-based MedAlliance said an 82-year-old Taiwanese man enrolled in the initial trial. It will evaluate the Selution SLR sirolimus-eluting balloon for the treatment of erectile dysfunction (ED). The Perfect-Selution FIM study includes 54 patients. […]
