Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more … [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
Medtronic wins FDA approval for new extended-wear infusion set
Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more … [Read More...]
Insulet touts full market launch of mobile apps for Omnipod Dash
Insulet (NSDQ:PODD) touted the full market launch of the Omnipod Display and Omnipod View apps for people using the company's Omnipod Dash system. The Display app enables users to display data from their Personal Diabetes Manager device onto their … [Read More...]
On mixed Q2 results, Glaukos announces Avedro buy
Glaukos (NYSE:GKOS) posted its second-quarter financial results this week and reported that it plans to acquire Avedro in an effort to build out its corneal health franchise. Avedro develops single-use drug formulations designed to strengthen … [Read More...]
Omnipod Dash sales drive Insulet Q2 results
Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or … [Read More...]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent … [Read More...]
Bigfoot Biomedical inks deal with Pittsburgh health system
Bigfoot Biomedical today announced an agreement with Pittsburgh-based Allegheny Health Network (AHN) to further develop Bigfoot's Unity investigational insulin delivery wireless platform. The diabetes startup described Unity as a first-in-kind, … [Read More...]
Dexcom posts Street-beating Q2 earnings
Dexcom (NSDQ:DXCM) posted second-quarter results this evening that beat the consensus forecast on Wall Street, and raised its outlook for the rest of the year. The San Diego–based continuous glucose monitoring (CGM) technology company reported a … [Read More...]
Veramorph lands spot in Delaware accelerator
Veramorph Materials landed a spot in a Delaware business accelerator backed by DuPont to develop its hydrogel-based oral drug delivery platform. Veramorph and MCET Technologies (which is developing wearable sensor technology) won their spots in … [Read More...]
Pfizer to absorb Mylan in off-patent drug spinout
Pfizer (NYSE:PFE) plans to absorb Mylan (NSDQ:MYL) as part of the spinout of its Upjohn off-patent drugs business in an all-stock deal. The deal, structured to avoid taxes on any gains from the spinout, would see each Mylan share converted into a … [Read More...]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with … [Read More...]
In case you missed it
- Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
- FDA approves delivery system for Intersect ENT’s Propel implant
- Livongo share prices double after upsized $356m IPO
- Eli Lilly, Aptar win FDA approval for nasal glucagon powder
- FDA issues new postmarket guidance for drug-device products
- Livongo boosts IPO to $268m midpoint
- Medtronic bids for expanded FDA indication for Guardian Sensor 3
- Frequency Therapeutics inks $625m deal with Astellas, adds $62m Series C
- Glaukos licenses eye drug-delivery tech from Intratus
- BD updates infusion pump recalls
- Senseonics prices $107m worth of stock, debt offerings
- Senseonics slides on stock, debt offerings, Q2 prelims
- Avoset to develop infusion pump with unnamed pharma giant
- Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
- AxoSim touts results of nerve-on-a-chip study
Clinical Trials
Medtronic wins FDA approval for new extended-wear infusion set
Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be […]
Taris Biomedical touts results of bladder cancer treatment study
Taris Biomedical today announced positive results from the second arm of a study of its TAR-200 system for the treatment of patients with muscle-invasive bladder cancer (MIBC). The most recent study arm involved 10 patients treated with TAR-200 and yielded positive safety, tolerability and preliminary efficacy data, according to Lexington, Mass.-based Taris. Combined data from […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here […]
Beta Bionics touts results of bionic pancreas system study
Beta Bionics’ iLet bionic pancreas system significantly increased the percentage of time that adults with Type 1 diabetes spent with glucose levels between 70–180 mg/dl when compared to usual care therapy, according to a new study. The study’s results also suggest that the iLet, using either the Senseonics (NYSE:SENS) Eversense continuous glucose monitoring system (CGM) […]
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