Medtech and pharmaceutical companies have made several important strides over the past year when it comes to improving diabetes treatment. Multiple treatments and technologies have cleared regulatory hurdles and are now hitting the market and making the process of living with diabetes that much more manageable. Several different styles of therapy and devices have come […]
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Phillips-Medisize expands Denmark site
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 […]
Indiana man may proceed with pain pump lawsuit against Medtronic
An Indiana federal judge on Friday dismissed two parts of a lawsuit against Medtronic (NYSE:MDT), but said that the plaintiff can continue to pursue the third count. Kirk Bledsoe sued Medtronic in Indiana state court in 2017 after the company’s Synchromed II pain pump, which Bledsoe had implanted in 2011, failed on two occasions and […]
CF PharmTech raises $90m
Pharmaceutical company CF PharmTech, which focuses on respiratory treatments, announced today that it raised $90 million in a Series E financing round. Shuzhou, China–based CF PharmTech said the latest round of funding reflects strong support from China’s investors and will allow the company to bring new products from its pipeline to market. The company produces […]
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 […]
Delcath Systems announces reverse stock split
A reverse stock split went into effect today for Delcath Systems (OTC:DCTH) — developer of the Chemostat hepatic delivery system for treating cancer. The 1-for-700 reverse stock split is meant to reduce the number of common stock shares and shares reserved for issuance to 1.2 million, from a previous 1.4 billion. The authorized number of shares […]
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 […]