Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received approval to deliver Lyumjev ultra-rapid acting insulin with its t:slim X2 pump. Eli Lilly offers the Lyumjev (insulin lispro-aabc injection) ultra-rapid acting insulin. Tandem can now provide its t:slim X2 pump with Control-IQ+ automated insulin delivery technology with the insulin in the U.S. This latest clearance […]
Pharmaceuticals
Roche wins CE mark for Susvimo drug-eluting eye implant
Roche announced today that it received CE mark approval for its port delivery platform containing its Susvimo therapeutic. The device, known as Contivue in Europe, comprises the eye implant through which Susvimo is delivered, plus four ancillary devices to initially fill, insert, refill and remove the implant if required. Susvimo (ranibizumab injection) 100 mg/mL remains […]
Ypsomed gets FDA nod for digital add-on for autoinjectors
Ypsomed announced that the FDA granted 510(k) clearance for SmartPilot, a digital connectivity add-on for its Ypsomate autoinjectors. The device transforms the YpsoMate into a connected system that automatically captures and transmits injection data. Ypsomed said this marks an important step toward digital health solutions that offer deeper insight into therapy use. The digital add-on […]
MannKind enters cardiometabolic, lung disease drug delivery space with scPharmaceuticals acquisition
MannKind (Nasdaq:MNKD) announced today that it entered into a definitive agreement under which it acquires scPharmaceuticals. The proposed acquisition could deliver MannKind’s strategic expansion into cardiorenal medicine. Danbury, Connecticut-based MannKind already offers inhaled insulin therapy. scPharmaceuticals, meanwhile, markets Furoscix, an FDA-approved on-body unfuser delivering furosemide. Furosemide currently serves as the standard for treating fluid overload […]
Vaxxas raises $58.4M for needle-free vaccine delivery tech, announces CEO change
Vaxxas announced today that it raised $58.4 million (A$90 million) in a new financing round supporting its vaccine delivery technology. The Brisbane, Australia-based company picked up about $32 million in new Series D equity and about $26 million in debt facilities. It also has additional commitments under discussion as it continues to attract investor interest. […]
Vivani closes $10M financing, advances GLP-1 implant
Vivani Medical (Nasdaq:VANI) announced that it brought in $10 million in equity financing as it progresses its drug delivery technology. Alameda, California-based Vivani develops NanoPortal technology, which steadily delivers medication over extended periods of time. The company aims to guarantee correct patient doses while avoiding potential safety concerns around fluctuating drug release profiles. It can also […]
Drug delivery tech developer Stevanato Group brings in $235.5M financing
Stevanato Group today announced that it secured $235.5 million (€200 million) in financing to support ongoing capital expenditure projects. The Piombino Dese, Italy-based drug delivery device developer plans to use funds to support projects in Cisterna di Latina (Italy) and Fishers, Indiana. It picked up the funds through agreements with BNL BNP Paribas, Cassa Depositi […]
BD announces first pharma-sponsored clinical trial for wearable injector
BD (NYSE:BDX) today announced the first pharma-sponsored combination product clinical trial using its wearable injector technology. The study uses the BD Libertas wearable injector for the subcutaneous delivery of complex biologics. The company said it represents a significant advancement in accelerating innovation in drug-device combination products. It could provide greater flexibility for patients, including potential […]
Johnson & Johnson, Pacira ink strategic co-promotion agreement for non-opioid pain therapies
Johnson & Johnson MedTech (NYSE:JNJ) today announced a strategic co-promotion agreement with Pacira BioSciences. The agreement expands the J&J MedTech Early Intervention portfolio with Pacira’s Zilretta. Zilretta (triamcinolone acetonide extended-release injectable suspension) is an extended-release injectable for the treatment of pain related to osteoarthritis (OA) of the knee. Zilretta first received FDA approval in October […]
Ypsomed brings autoinjector for dual GCG/GLP-1 delivery to China
Ypsomed announced today that Chinese regulatory authorities approved the a dual GCP/GLP-1 drug delivered using its auto-injector. The Chinese National Medical Products Administration (NMPA) approved Maxdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, developed by Innovent Biologics. It treats people with obesity through delivery with an YpsoMate 1.0 auto-injector variant. YpsoMate, a user-friendly […]
