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Sean Whooley

BioCorp, Roche launch Mallya smart insulin pen in France

April 13, 2021 By Sean Whooley

BioCorp Roche

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 […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: biocorp, Roche

Genentech wins FDA approval for Xolair prefilled syringe

April 12, 2021 By Sean Whooley

Genentech logo updated

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, […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: FDA, Genentech

Lyra Therapeutics touts results from chronic rhinosinusitis treatment trial

April 12, 2021 By Sean Whooley

Lyra Therapeutics LYR-210

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Otolaryngology Ear, Nose & Throat Tagged With: Lyra Therapeutics

TriSalus, University of Texas to collaborate on solid tumor treatment study

April 8, 2021 By Sean Whooley

TriSalus-logo

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 […]

Filed Under: Business/Financial News, Clinical Trials, Drug-Device Combinations, Featured, Immunotherapy, Oncology Tagged With: trisaluslifesciences, University of Texas MD Anderson Cancer Center

Teva Pharmaceuticals receives European approval for Spiromax inhalers

April 8, 2021 By Sean Whooley

Teva

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Respiratory Tagged With: Teva, Teva Pharmaceuticals

Medtronic commits to helping people of color with diabetes

April 7, 2021 By Sean Whooley

Medtronic logo updated

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Funding Roundup Tagged With: American Diabetes Association, Medtronic

Better Therapeutics to go public via $113M merger with SPAC

April 7, 2021 By Sean Whooley

Better Therapeutics

Better Therapeutics announced today that it will go public through a $113 million merger with Mountain Crest Acquisition Corp II 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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Mergers & Acquisitions, Wall Street Beat Tagged With: Better Therapeutics, Mountain Crest SPAC

Intravacc touts preclinical, non-human results for COVID-19 nasal spray vaccine

April 7, 2021 By Sean Whooley

Intravacc

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 […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Preclinical Trials Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Intravacc

Kindeva, Cambridge Healthcare Innovations to collaborate on dry-powder inhaler

April 7, 2021 By Sean Whooley

Kindeva Drug Delivery Cambridge Healthcare Innovations Aelous_Device

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory Tagged With: Cambridge Healthcare Innovations, Kindeva Drug Delivery

Pear Therapeutics inks multiple agreements to expand digital therapeutic platform

April 6, 2021 By Sean Whooley

Pear Therapeutics

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, […]

Filed Under: Business/Financial News, Contract Services, Drug-Device Combinations, Featured, Neurological, Patient Monitoring, Pharmaceuticals Tagged With: Empatica, etectrx, KeyWise, peartherapeutics

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