A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device. Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming […]
Auto-injectors
FDA approves Guerbet’s Optiray imaging bulk package
Guerbet (EPA:GBT), which specializes in medical imaging including contrast agents, has received FDA approval for its Optiray imaging bulk package, which can be used to fill sterile disposable syringes for use with CT imaging. The imaging bulk package is intended to reduce the number of single-dose vials when used with a power injector and contrast […]
Xeris Pharmaceuticals launches autoinjector for severe hypoglycemia
Xeris Pharmaceuticals today said it has launched its Gvoke HypoPen glucagon injection to treat severe hypoglycemia. The autoinjector is designed to treat severe hypoglycemia in adults and children with diabetes that are ages two years and older. The premixed autoinjector has no visible needle and has a reliable delivery method. According to the company, 99% […]
Abbott, Tandem seal deal to combine CGM, insulin delivery tech
Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems. The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]
Abbott, Medtronic go head-to-head at ADA conference
Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
Meridian Medical Technologies recalls EpiPen and EpiPen Jr auto-injectors
Meridian Medical Technologies issued a voluntary recall for 13 lots of the Mylan EpiPen and EpiPen Jr. Auto-Injectors. The recall stems from the potential of the devices to contain a defective part that could result in the devices’s failure to activate. The company says the number of reported failures is small, but the defective part […]
Beta Bionics’ bionic pancreas wins breakthrough status from FDA
The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
Regenxbio pulls trigger on option to license Clearside Biomedical’s SCS Microinjector
Clearside Biomedical (NSDQ:CLSD) said yesterday that Regenxbio (NSDQ:RGNX) exercised its option to license Clearside’s in-office SCS Microinjector for delivering adeno-associated virus (AAV)-based therapeutics in treating wet age-related macular degeneration, diabetic retinopathy and other conditions. The two companies inked the option and licensing deal that they said at the time could be worth more than $130 million on […]
BD launches syringe-autoinjector combo
Becton Dickinson (NYSE:BDX) today announced the launch of the BD Intevia 1mL two-step disposable autoinjector, which combines an autoinjector and pre-fillable syringe in one integrated system. BD Intevia disposable autoinjector is a 2-step push-on-skin device that is designed to effectively and safely inject a variety of drugs of different viscosities up to 35cP and different […]
