Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it made a number of changes on its board of directors. Dublin, Ohio–based Navidea ‘s chair of the board and director S. Kathryn Rouan, along with director Claudine Bruck, retired from those positions, effective immediately. The board appointed Alexander L. Cappello and John K. Scott, Jr., both existing members […]
Pharmaceuticals
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. […]
Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic
Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of […]
Oramed hits 50% enrollment in Phase 2 trial for oral insulin capsule
Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it reached over 50% enrollment in a trial for its oral insulin treatment. New York-based Oramed’s Phase 2 trial evaluates its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis (NASH), with patients continuing to be screened at sites in the U.S. and Israel, according to a news […]
Impel NeuroPharma prices $45M offering following FDA approval for migraine treatment
Impel NeuroPharma (NSDQ:IMPL) announced that it priced an underwritten public offering of common stock worth $45 million. The offering includes 3 million shares of common stock priced to the public at $15 per share, with gross proceeds set to total $45 million before deducting underwriting discounts and commissions and other offering expenses payable by Impel […]
Dermavant doses first patient in trial of topical cream for atopic dermatitis
Dermavant Sciences announced today that it dosed the first patient in a Phase 3 pivotal study of its atopic dermatitis (AD) treatment. Long Beach, California-based Dermavant’s double-blind, vehicle-controlled pivotal study evaluates tapinarof for the treatment of AD, according to a news release. The company developed tapinarof as an investigational novel, therapeutic aryl hydrocarbon receptor modulating […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after […]
Overcoming vaccine delivery device design’s top challenges
Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world. Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
Three companies to collaborate on potential inhaled COVID-19 treatment
Signal Rx Pharmaceuticals, Crystec and ADYA are working on a dry powder drug formulation for potentially treating COVID-19-related illness. The three companies’ collaboration for the dry powder formulation of SF2523 covers the treatment of pulmonary fibrosis, lung cancer and illnesses related to SARS-CoV-2, the virus causing COVID-19. SignalRx’s SF2523 is a novel, small-molecule, dual PI3K-BRD4 […]
