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 […]
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 […]
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 […]
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 intravenous and subcutaneous non-electric infusion with a selectable rate flow controller — the IV Controller and the OneSett. According to […]
American Lung Association slams cigarette maker for inhaled medical therapy acquisition
The American Lung Association condemned the recently announced acquisition of Vectura by cigarette maker Philip Morris (NYSE:PM). Earlier this month, Philip Morris announced that it agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion. In response to the acquisition, American Lung Association president & CEO Harold Wimmer and American Thoracic Society president Dr. Lynn […]
Xeris, Tetra Pharma enter $71M licensing agreement for glucagon injection
Xeris Pharmaceuticals (NSDQ:XERS) announced today that it entered into an exclusive agreement with Tetris Pharma to commercialize Ogluo. Chicago-based Xeris designed Ogluo (Gvoke PFS and Gvoke HypoPen in the U.S.) to be a ready-to-use, pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia in adults, adolescents and children two years of age and older with diabetes […]
FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]
Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’
As we enter what may be the “new normal,” Dexcom’s CEO bets the company can pave the way in continuous glucose monitoring. Dexcom (NSDQ:DXCM), like any company seeking to innovate, remains in a state of perpetual forward motion. That’s the way chair, president & CEO Kevin Sayer views it, anyway. As the company looks toward […]
