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 for the three months ended June 30, 2021, for a 35.9% bottom-line gain on sales growth of 31.7%. Adjusted […]
Drug-Device Combinations
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 the world’s largest medical device companies — was up 0.9% on the day. The St. Helier, N.J.-based […]
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) submission to cover a host of software fixes, with pumps only going to health providers […]
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 with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The […]
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 three months ended June 30, 2021, more than doubling its bottom-line on sales growth of 37.3%. Adjusted to […]
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 […]
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 three months ended June 30, 2021, for a 47.9% bottom-line gain on sales growth of 1%. Adjusted […]
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 arteries in patients with coronary artery disease. Get the full story on our sister site, Medical Tubing + Extrusion.
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. 11,058,638) involves the targeted delivery of therapeutics to cancer cells. The company’s technology fuses the tyrosine isomer racemetryosine (α-methylparatyrosine) with a second therapeutic […]
