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 … [Read More...]
Sponsored Content
Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
Smith & Nephew acquires Tusker Medical
Smith & Nephew (NYSE:SNN) today said it acquired Tusker Medical for an undisclosed amount. Tusker Medical develops the Tula System, which is an in-office ear tube delivery system to treat recurrent or persistent ear infections. The pediatric … [Read More...]
Medtronic launches data management software program for Synchromed II
Medtronic (NYSE:MDT) this week launched a cloud-based data management software platform for its Synchromed II drug delivery system. The Efficio platform is designed to allow clinicians to manage targeted drug delivery pump practices to treat … [Read More...]
Tandem Diabetes Care launches t:slim X2 with Control-IQ in U.S.
Tandem Diabetes Care (NSDQ:TNDM) announced today that it began the U.S. commercial launch of its t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology. In December, the San Diego-based company announced that the FDA cleared … [Read More...]
Abbott boosts support for Bigfoot Biomedical and its diabetes treatment tech
Diabetes treatment tech company Bigfoot Biomedical has raised another $45 million in the initial tranche of a Series C equity financing, with collaborator Abbott (NYSE:ABT) as the lead investor. “We are excited to announce Abbott’s deepening … [Read More...]
7 medtech advances to improve diabetes treatment
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
In case you missed it
- FDA wants feedback on combination products guidance
- Delcath Systems announces reverse stock split
- Smiths Medical recalls Medfusion 4000 due to issue with software update
- Medtronic adds AI-fueled Klue to its diabetes management lineup
- Lilly to integrate DexCom CGMs in automated dosing system
- Dexcom CEO apologizes for remote monitoring outage
- FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
- 3M to sell drug-delivery biz to Altaris Capital Partners for $650m
- Beta Bionics’ bionic pancreas wins breakthrough status from FDA
- Proteus Digital Health restructuring amid reported funding woes
- Dexcom warns of potential danger to European app users
- Report: 3M may sell off its drug-delivery business for $1 billion
- W.L. Gore officials think they can spur insulin delivery system innovation
- J&J’s Ethicon launches Vistaseal fibrin sealant
- ‘Hubble Space Telescope’ for genomics could yield new drugs, materials
Clinical Trials
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 […]
NIH study: Tandem Diabetes artificial pancreas bests other treatments
A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
Boehringer Ingelheim touts Spiolto Respimat inhaler data
Boehringer Ingelheim said yesterday that results from a study of its Spiolto Respimat inhaler showed benefits including improving symptoms and lung function in treating chronic obstructive pulmonary disease. The Spiolto Respimat is a soft-mist inhaler designed for the treatment of airflow obstruction in patients with COPD. A pooled analysis exploring COPD treatment with the tiotropium-based […]
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