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 … [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
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
Proteus Digital Health restructuring amid reported funding woes
Proteus Digital Health said today that it is restructuring, reportedly because it failed to close a $100 million funding round. A report by CNBC said the Redwood City, Calif.-based company missed the funding target. Once valued at $1.5 billion, … [Read More...]
Dexcom warns of potential danger to European app users
Dexcom (NSDQ:DXCM) is warning European customers who have failed to updated the G6 iOS app for their G6 continuous glucose monitor that they may not receive scheduled alerts of high or low blood sugar. Failure to update to version 1.5.4 of the app … [Read More...]
Report: 3M may sell off its drug-delivery business for $1 billion
3M (NYSE:MMM)may try to sell off its drug-delivery business in a deal that could fetch $1 billion, according to a report by Bloomberg. The drug delivery division makes transdermal drug patches, microneedle delivery systems, nasal devices, oral … [Read More...]
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore's Micro-Equity Investment … [Read More...]
J&J’s Ethicon launches Vistaseal fibrin sealant
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced today that it launched its Vistaseal fibrin sealant for managing bleeding during surgery. The sealant system is indicated as an adjunct to hemostasis for mild to moderate bleeding in … [Read More...]
‘Hubble Space Telescope’ for genomics could yield new drugs, materials
Researchers in Spain have developed a new genomics tool that can classify how species are related to each other at far larger scales than previously possible and may yield new drugs, materials and foods — and pinpoint strategies for saving species at … [Read More...]
OncoSec $30m fundraise threatened by spat
OncoSec Medical (NSDQ:ONCS) is embroiled in a lawsuit and proxy war over a $30 million money-raise as it seeks to continue development of its cancer treatment technology. The company — headquartered in San Diego and Pennington, N.J. — sent a … [Read More...]
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- Ocular Therapeutix dips on Q3 losses
- InCarda Therapeutics raises $35 million
- Insulet Q3 earnings beat The Street despite bottom-line slide
- Log Pharma Packaging launches smart packaging
- Surmodics shares drop on Q3 earnings, Sundance DCB wins breakthrough FDA nod
- Intersect ENT’s Q3 beats on sales, misses on earnings
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Clinical Trials
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 […]
Philips touts Stellarex balloon study
Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]
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