MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon. Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020. Get the full […]
Drug-Device Combinations
FDA approves Baxter’s norepinephrine injection for treating low blood pressure
Baxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection. Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). Get the full story at our sister site, Drug Delivery Business News.
BD says glass prefillable syringes still perform after deep cold storage
BD (NYSE:BDX) today shared the results from a preliminary study investigating the impact of deep cold storage on glass prefillable syringes. Franklin Lakes, N.J.-based BD’s study evaluated deep cold storage (-20°C and -40°C) as traditional vaccine formulations are commonly stored up to about 2°C to 8°C, while mRNA vaccine formulations (the type of COVID-19 vaccine made […]
Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform
Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform. Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes. Get the full story at our sister site, […]
IVX Health raises $100M to accelerate expansion for infusion centers
IVX Health announced today that it completed a $100 million Series F minority investment round from Great Hill Partners. Nashville, Tennessee-based IVX plans to utilize the funding to accelerate its entry into new markets in 2022 and beyond in its effort to make its outpatient infusion centers the country’s preferred destination for pharmaceutical care for patients […]
FDA approves first Lucentis injection biosimilar for treating eye diseases
The FDA announced today that it approved Samsung Bioepis’ Byooviz injection, making it the first approved biosimilar to Lucentis for treating eye diseases. Byooviz (ranibizumab-nuna), the first biosimilar to Lucentis (ranibizumab injection), treats several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD). The treatment is administered by intravitreal injection (delivered into the […]
Glaukos announces licensing deal with Attillaps for pharmaceutical compounds
Glaukos (NYSE:GKOS) announced today that it entered into a licensing agreement with Attillaps for its library of pharmaceutical compounds. San Clemente, California-based Glaukos was granted a global exclusive license to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites — the root cause of Demodex blepharitis […]
Boston Scientific touts data from Phase 3 study of selective internal radiation therapy
Boston Scientific (NYSE:BSX) today touted data from a Phase 3 clinical trial of its TheraSphere Y-90 glass microspheres treatment. In the trial, the TheraSphere treatment successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) in patients with metastatic colorectal cancer (mCRC) of the liver. Get the full story at our sister […]
Navidea Biopharmaceuticals makes board of directors changes
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. Get the full story at our sister site, Drug Delivery Business News.
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. The recommendation […]
Alfred E. Mann Foundation sells insulin infusion pump IP to Medtronic
The Alfred E. Mann Foundation for Scientific Research (AMF) today announced the sale of intellectual property to Medtronic (NYSE:MDT). As part of the transaction of IP related to implanted infusion pumps, AMF will work with Medtronic to develop the technology into a next-generation implantable insulin pump for people living with hard-to-treat type 1 diabetes in Europe. Get […]
