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 … [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
Avoset to develop infusion pump with unnamed pharma giant
Avoset Health said this week that it plans to develop a connected infusion pump with an unnamed pharmaceutical company. The product is set to debut in early 2021. The company touted that its technology allows physicians and pharmacists to track … [Read More...]
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 … [Read More...]
AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip … [Read More...]
Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside's Suprachoroidal Space Microinjector is … [Read More...]
Valeritas touts study results
Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using … [Read More...]
NovaBay raises $2.4m
NovaBay Pharmaceuticals (NYSE:NBY) said this week that it raised $2.4 million in an offering that included three investors. The Emeryville, Calif.-based company has developed products for the eye care market, including a prescription for managing … [Read More...]
AgaMatrix raises $56m for WaveForm CGM
AgaMatrix said today that it brought in a $56 million funding round for the eponymous continuous glucose monitor its WaveForm Technologies subsidiary is developing. The round, which includes $6 million from new and existing backers and $50 million … [Read More...]
Biocorp, Sanofi ink €4m Mallya sensor deal
Biocorp (PAR:ALCOR) said today that it inked a deal with pharma giant Sanofi (NYSE:SNY) to integrate its Mallya sensor into Sanofi's diabetes management platform. Issoire, France-based Biocorp's Mallya is designed to clip to an injection pen to … [Read More...]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in … [Read More...]
Livongo Health files for $100m IPO
Livongo Health last week filed for an initial public offering worth $100 million for the digital health platform it developed to treat chronic diseases. The Mountain View, Calif.-based company's initial focus on diabetes involves a smart, … [Read More...]
In case you missed it
- SEC accuses lawyers in $1.7m PixarBio fraud
- Glaukos closes $3m Dose Medical buy
- Vectura seeks another $44M in GSK patent win
- Apple stores to sell One Drop glucose monitor
- Taris Biomedical touts results of bladder cancer treatment study
- Medtronic recalls MiniMed pump models on cybersecurity risk
- AbbVie to buy Allergan for $63 billion
- FDA panel wants more, better data on paclitaxel-eluting devices
- Ocular Therapeutix gains second indication for drug-delivery eye insert
- FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
- Inside Insulet’s pivotal year with CEO Shacey Petrovic
- Glaukos puts up nearly $3m to buy Dose Medical back
- J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
- FDA: More data needed on paclitaxel devices
- Ginkgo puts $80 million into Synlogic
Clinical Trials
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) […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
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