A 70-year-old man may proceed with a lawsuit claiming that Medtronic’s SynchroMed II infusion pump is defective and that the company was negligent in manufacturing it. A U.S. District Court judge in West Virginia last week denied Medtronic’s motion to dismiss the lawsuit brought by John David Brumfield, who claims that the pump in the […]
Lilly to add Welldoc app to future insulin pen
Eli Lilly (NYSE:LLY) and Welldoc announced a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin pens, which are in development. Lilly and Welldoc will create a new version of Welldoc’s BlueStar insulin management software, which will integrate insulin dosing data for several Lilly insulins. The BlueStar app has FDA 510(k) clearance for […]
Biden’s COVID-19 response will make manufacturers busy
Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, […]
Mylan must face EpiPen racketeering lawsuit
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 […]
Eitan Medical lands FDA clearance for infusion pump system upgrade
Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories. The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical […]
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
Evonik buys polymers business from Durect Corp.
Evonik said today that it has acquired the Lactel PLGA-based polymers business from Durect Corp. All Durect employees associated with the Lactel business in Birmingham, Ala., accepted the offer to join Evonik in similar roles, according to Essen, Germany-based Evonik. The deal closed Dec. 31, 2020. Evonik will integrate the Lactel biodegradable polymers line into its […]
Appeals court nixes GSK’s petition for new trial in Vectura patent spat
The Federal Circuit Court has rejected Glaxo Smith Kline’s (NYSE:GSK) petition for a new trial in a patent case brought by British inhaler company Vectura. The circuit court upheld a May 2019 jury verdict in U.S. District Court for the District of Delaware, awarding Ventura $89.7 million damages for the period from August 2016 through […]
Medtronic launches ‘smart’ insulin pen
Medtronic (NYSE:MDT) today announced the launch of its InPen “smart” insulin pen integrated with real-time Guardian Connect continuous glucose monitor (CGM) data. The Fridley, Minn.-based medtech giant is touting InPen as the first and only FDA-cleared smart insulin pen on the market for people on multiple daily insulin injections. The system is designed to provide real-time […]
Medtronic must face infusion pump lawsuit
A federal judge in Missouri has blocked an effort by Medtronic (NYSE:MDT) to dismiss a lawsuit alleging that the failure of one of its infusion pumps caused “severe and permanent injuries.” Plaintiff Carissa Sullivan, who has cerebral palsy and spastic quadriplegia, claims that the SynchroMed II infusion pump she had implanted in 2011 failed in 2015, causing […]
