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 … [Read More...] about Satsuma launches Phase 3 trial for acute migraine combination product
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Noble expands its services for its clients into Human Factors
Human Factors + (HF+) is a natural extension of Noble’s deep understanding of the patient experience relative to self-administering drug therapies By Tim McLeroy, Executive Director of Marketing … [Read More...] about Noble expands its services for its clients into Human Factors
Featured Posts
Dexcom rises on Street-beating Q2, raised guidance
Dexcom (NSDQ:DXCM) shares ticked up after hours on second-quarter results that topped the consensus forecast. The San Diego-based continuous glucose monitor developer posted profits of $62.9 million, or 63¢ per share, on sales of $595.1 million … [Read More...] about Dexcom rises on Street-beating Q2, raised guidance
Novocure plummets on missed Q2 projections
Novocure (NSDQ:NVCR) shares took a dive today on second-quarter results that came up short of the consensus forecast. NVCR shares were down -11.7% at $160.67 in mid-afternoon trading today. MassDevice's MedTech 100 Index — which includes stocks of … [Read More...] about Novocure plummets on missed Q2 projections
BD begins remediation in Alaris infusion system software recall
BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system. Franklin Lakes, N.J.–based BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) … [Read More...] about BD begins remediation in Alaris infusion system software recall
FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics
Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar. Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients … [Read More...] about FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics
West Pharmaceutial Services beats The Street, raises guidance
West Pharmaceutical Services (NYSE:WST) shares ticked up before hours on second-quarter results that beat the consensus forecast. The Exton, Pa.-based company posted profits of $187.3 million, or $2.47 per share, on sales of $723.6 million for the … [Read More...] about West Pharmaceutial Services beats The Street, raises guidance
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 … [Read More...] about FDA warns on increased risk of death with Pepaxto for multiple myeloma
Teva dips before hours on Q2 revenue miss, lowered guidance
Teva Pharmaceuticals (NYSE:TEVA) shares took a hit this morning on second-quarter revenues that missed the consensus forecast. The Tel Aviv, Israel-based company posted profits of $207 million, or 19¢ per share, on sales of $3.9 billion for the … [Read More...] about Teva dips before hours on Q2 revenue miss, lowered guidance
Medtronic launches Prevail drug-coated balloon catheter in Europe
Medtronic (NYSE:MDT) today announced that it has launched its Prevail drug-coated balloon catheter in Europe. The medtech giant designed the Prevail catheter for percutaneous coronary intervention procedures to treat narrowed or blocked coronary … [Read More...] about Medtronic launches Prevail drug-coated balloon catheter in Europe
Tyme wins U.S. patent for drug delivery method for cancer treatment
Tyme Technologies (NSDQ:TYME) announced today that it received a U.S. patent for its metabolomic drug delivery platform. Bedminster, N.J.-based Tyme's additional patent claims related to the metabolomic technology platform (U.S. Patent No. … [Read More...] about Tyme wins U.S. patent for drug delivery method for cancer treatment
Innovative Health Sciences wins CE mark for syringe infusion system
Innovative Health Sciences announced today that it received CE mark approval in Europe for its Insignis syringe infusion system. Chester, N.Y.–based Innovative Health Sciences designed the Insignis syringe infusion system to offer a combination of … [Read More...] about Innovative Health Sciences wins CE mark for syringe infusion system
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Clinical Trials
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 […]
