Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. South San Francisco-based Vaxart’s S+N oral tablet SARS-CoV-2 vaccine candidate […]
Clinical Trials
Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent
Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
Satsuma launches Phase 3 trial for acute migraine combination product
Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have […]
FDA warns on increased risk of death with Pepaxto for multiple myeloma
The FDA today issued a notice warning patients and healthcare professionals of a potentially increased risk of death with Pepaxto. Pepaxto (melphalan flufenamide), used with dexamethasone to treat patients with multiple myeloma, demonstrated an increased risk of death in the OCEAN clinical trial. The FDA required that the manufacturer, Boston-based Oncopeptides (STO:ONCO) suspend enrollment for […]
Pear Therapeutics touts 9-month data for reSET-O
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). According to a news release, results from the nine-month real-world data analysis demonstrated a continued long-term reduction in costly healthcare […]
DarioHealth touts data for diabetes management platform
DarioHealth (NSDQ:DRIO) recently presented data supporting its artificial intelligence (AI)-powered diabetes management platform. New York-based Dario’s research examined users who were given access to a new product experience designed to drive better health habits and behaviors through its AI-driven personalization engine. According to a news release, results —presented at the American Diabetes Association (ADA) 81st […]
PharmaJet begins enrollment for needle-free COVID-19 vaccine trial
PharmaJet announced today that it began enrollment for a Phase 1 clinical trial for its needle-free COVID-19 vaccine in Australia. Golden, Colo.-based PharmaJet’s needle-free injection systems will be studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. According to a news release, PharmaJet’s system was chosen […]
United Therapeutics touts study results for inhaled Tyvaso treatment
United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment. Research Triangle Park, N.C.–based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020. The posthoc analysis of […]
Medtronic touts trial results for InPen smart insulin pen, extended infusion system
Medtronic (NYSE:MDT) today presented positive study results for its InPen smart insulin pen and its extended-wear infusion set. Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM). According to a news release, data […]
Senseonics touts new next-gen Eversense CGM data
Senseonics (NYSE:SENS) today presented further positive data evaluating its next-generation Eversense continuous glucose monitoring system. Germantown, Md.–based Senseonics presented data from the Promise study at the American Diabetes Association Virtual 81st Annual Scientific Sessions. The data adds to positive results already presented by the company at the beginning of this month that demonstrated high levels […]