Phillips-Medisize, a Molex company, announced today that it has expanded its Global Innovation and Development site in Struer, Denmark. The Hudson, Wis.–based company — a contract manufacturing giant in the drug delivery device space — plans to open a dedicated Manufacturing Development and Clinical build unit in Stuer by the second quarter of 2020. Get […]
Dyve Biosciences hires new chief scientific officer
Transdermal drug therapy developer Dyve Biosciences announced that it appointed longtime Pfizer executive Chuck Harbert to the role of chief scientific officer. Harbert spent three decades at Pfizer, serving as the company’s VP of U.S. exploratory development and strategic planning, among other senior positions with Pfizer Central Research. He is the inventor and co-inventor of 35 pharmaceutical […]
Medinol stent performs just as well as Medtronic Resolute, study says
The EluNIR drug-eluting stent made by Medinol performed just as well as the Resolute Integrity or Resolute Onyx stents from Medtronic (NYSE:MDT), according to new clinical study results from an international team of researchers. The randomized clinical trial — conducted by researchers from the U.S., Israel, Canada and the Netherlands — involved 2,221 people and compared […]
FDA wants feedback on combination products guidance
The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]
Medtronic adds AI-fueled Klue to its diabetes management lineup
Medtronic (NYSE:MDT) said today it has completed the acquisition of Klue, a San Jose, Calif.-based software company that tracks people’s eating in real-time and analyzes it with artificial intelligence (AI) to help control diabetes. Medtronic plans to incorporate Klue’s technology into its Personalized Closed Loop (PCL) insulin pump system, which won FDA breakthrough device designation […]
Lilly to integrate DexCom CGMs in automated dosing system
Eli Lilly (NYSE:LLY) announced that it will integrate Dexcom (NSDQ:DXCM) products into its personalized diabetes management system, now under development. Under the new, non-exclusive agreement, Indianapolis-based Lilly will use San Diego-based Dexcom’s continuous glucose monitoring (CGM) devices in pen-based and pump-based platforms in Lily’s diabetes management system. The pen-based platform is designed to integrate personalized data from […]
Dexcom CEO apologizes for remote monitoring outage
Dexcom (NSDQ:DXCM) CEO Kevin Sayer publicly apologized on Friday for an outage over Thanksgiving weekend that cut off users’ ability to share glucose monitoring data with caregivers and loved ones. The Dexcom Follow app normally allows users of the company’s G6 continuous glucose monitor to share that data with up to 10 people, according to the […]
FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM) t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately […]
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