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...]
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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
Phillips-Medisize wins contract for wearable combination product
Phillips-Medisize said today that it entered into an agreement with an unnamed biotechnology company to manufacture a wearable, electronic-enabled combination product for subcutaneous drug delivery. The hockey puck-sized product is designed as a … [Read More...]
West Pharmaceutical Services launches NovaPure drug-delivery system
West Pharmaceutical Services (NYSE:WST) said today that it's launching the NovaPure 3mL cartridge components with its NovaPure product line for delivery of higher-volume injectable drug-delivery systems. The Exton, Pa.-based company also announced … [Read More...]
Aptar Pharma’s two-dose nasal spray device to deliver epinephrine
Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar's Bidose (BDS) nasal device to deliver Bryn's epinephrine nasal spray (BRYN-NDS1C). Crystal Lake, Ill.-based Aptar's Bidose tech enables two-shot nasal drug delivery and will … [Read More...]
Clearside Biomedical confirms timeline for Xipere
Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere drug-delivery technology and will not ask for further clinical efficacy studies. The Xipere device is a suprachoroidal injection designed for the … [Read More...]
Concept Medical wins CE Mark for MagicTouch DCBs
Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for … [Read More...]
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear … [Read More...]
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 … [Read More...]
Gates Foundation backs Credence MedSystem’s drug-delivery device
Credence MedSystems said yesterday that it won a grant from the Bill & Melinda Gates Foundation for the development of its Companion dual-chamber reconstitution syringe for use in developing nations. The development project is meant to advance … [Read More...]
Senseonics touts Eversense reimbursement win
Senseonics (NYSE:SENS) said this week that Health Care Service Corporation - Blue Cross Blue Shield is providing coverage for the Eversense continuous glucose monitoring system, effective as of yesterday. HCSC - Blue Cross Blue Shield is the … [Read More...]
FDA approves Philips’ low-dose Stellarex balloons
Royal Philips (NYSE:PHG) said today that two of the company's new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg … [Read More...]
In case you missed it
- Intarcia Therapeutics takes another run at FDA approval
- Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Health
- BD to shutter Minnesota Lutonix plant, layoffs ahead for 53
- Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
- OcuMedic, Gelest ink drug-delivering contact lens deal
- BioCardia wins CE Mark renewal for Helix, Morph catheters
- Walmart brings One Drop wireless glucose meter kit to stores
- iRadimed clears 5-year-old warning letter
- Dexcom wins FDA clearance for G6 Pro CGM
- Haselmeier licenses Axis-D pen injector to Stevanato Group
- Intersect ENT’s Ascend study misses endpoint
- GSK seeks additional asthma indication for Trelegy Ellipta
- Frequency Therapeutics prices $84m IPO
- LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
- Valeritas jumps on $25m refi, Q3 prelims
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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