BioCorp and Roche Diabetes Care France announced the launch of the Mallya smart insulin pen device in France. Developed by BioCorp, Mallya is an intelligent sensor for insulin injection pens that has CE mark approval in Europe. The platform is compatible with any disposable insulin pen. It enables reliable monitoring for doses selected for injection and it offers […]
Drug-Device Combinations
Genentech wins FDA approval for Xolair prefilled syringe
Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe. South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, […]
Lyra Therapeutics touts results from chronic rhinosinusitis treatment trial
Lyra Therapeutics (NSDQ:LYRA) presented positive results from a Phase 2 study of its therapeutic for treating chronic rhinosinusitis (CRS). Watertown, Mass.-based Lyra’s Phase 2 Lantern study evaluated its LYR-210 long-acting product for CRS, which is administered in-office to deliver a sustained release for up to six months as a non-invasive alternative to surgery for patients […]
TriSalus, University of Texas to collaborate on solid tumor treatment study
TriSalus Life Sciences and the University of Texas today announced a collaboration to evaluate the treatment of solid tumors. The Texas MD Anderson Cancer Center and TriSalus will collaborate on treatments for tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint […]
Teva Pharmaceuticals receives European approval for Spiromax inhalers
Teva Pharmaceuticals announced today that it received European marketing authorization for its Seffalair and BroPair Spiromax inhalers. Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/ fluticasone propionate, 12.75/100 and 12.75/202 micrograms delivered doses) received approval as a maintenance treatment for asthma in adults and adolescents aged 12 years and older, according to a news […]
Medtronic commits to helping people of color with diabetes
Medtronic (NYSE:MDT) announced today that it entered multiple partnerships to help improve health equity for people of color living with diabetes. Fridley, Minn.-based Medtronic committed investments in partnerships with the American Diabetes Association (ADA) and the T1D Exchange, along with additional research efforts, to better understand and address such disparities, according to a news release. Get […]
Better Therapeutics to go public via $113M merger with SPAC
Better Therapeutics announced today that, through a $113 million merger with Mountain Crest Acquisition Corp II, it will go public. Mountain Crest, a publicly-traded, special purpose acquisition corporation (SPAC), will acquire Better Therapeutics in a deal expected to be completed in the summer of this year, with the company continuing to operate as Better Therapeutics […]
Intravacc touts preclinical, non-human results for COVID-19 nasal spray vaccine
Intravacc is today touting positive pre-clinical results of its SARS-CoV-2 nasal spray vaccine candidate in non-human subjects. Bilthoven, Netherlands-based Intravacc’s SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) nasal spray candidate was observed in four groups of mice and four groups of hamsters, all of which received two intranasal immunizations on day one and […]
Kindeva, Cambridge Healthcare Innovations to collaborate on dry-powder inhaler
Kindeva Drug Delivery and Cambridge Healthcare Innovations announced a collaboration to commercialize the latter’s dry-powder inhaler. St. Paul, Minn.-based Kindeva is set to use its product development, regulatory affairs and manufacturing capabilities to help develop and commercialize CHI’s Aeolus dry-powder inhaler (DPI) platform technology, according to a news release. Under the agreement, Kindeva will lead […]
Pear Therapeutics inks multiple agreements to expand digital therapeutic platform
Pear Therapeutics announced today that it entered into multiple agreements to bolster its prescription digital therapeutics (PDT) platform. Boston-based Pear Therapeutics’ agreements are set to add to its library of digital biomarkers, machine learning algorithms, sensor-based technologies and digital therapeutics, according to a news release. The agreements have been struck with technology companies including Empatica, […]
