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 … [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
AbbVie to buy Allergan for $63 billion
Pharmaceutical giant AbbVie (NYSE:ABBV) said today it will acquire Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie's blockbuster drug, Humira. AbbVie … [Read More...]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it's a class … [Read More...]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current … [Read More...]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel's chairman calling the data "a smoking gun, but no bullet or dead bodies at this … [Read More...]
Inside Insulet’s pivotal year with CEO Shacey Petrovic
It’s been a busy year at Insulet (NSDQ:PODD). The diabetes tech company welcomed a new CEO, launched its first new product in six years and officially opened its $200 million global headquarters – all in the first half of 2019. That’s all the … [Read More...]
Glaukos puts up nearly $3m to buy Dose Medical back
Glaukos (NYSE:GKOS) said yesterday that it agreed to pay nearly $3 million plus milestones to acquire former subsidiary Dose Medical and its drug-delivery technology for treating retinal diseases. Sam Clemente, Calif.-based Glaukos spun Dose out … [Read More...]
J&J’s Ethicon wins clearance for devices to deliver Grifols surgical sealant
Johnson & Johnson's Ethicon has won FDA clearance for airless spray devices to deliver Grifols' fibrin sealant to stop surgical bleeding, the companies announced today. The Vistaseal fibrin sealant will be the first product Grifols (NSDQ:GRFS) … [Read More...]
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting … [Read More...]
Ginkgo puts $80 million into Synlogic
Ginkgo Bioworks put $80 million into Synlogic (NSDQ:SYBX) last week in a deal to use its cell programming technology to accelerate development of Synlogic's synthetic biotic medicine program. Boston-based Gingko acquired some 6.3 million SYBX … [Read More...]
Inovio lands $8m Defense grant for intradermal delivery device
Inovio Pharmaceuticals (NSDQ:INO) said last week that it won an $8 million grant from a U.S. Defense Dept. agency for the intradermal delivery device it's developing. The U.S. Defense Threat Reduction Agency agreed to put more than $8.1 million … [Read More...]
In case you missed it
- Mercator MedSystems adds $3m
- Dance Biopharm raises $21m for insulin delivery device
- Ivenix wins 510(k) clearance for infusion system
- Medtronic, Tidepool ink deal for interoperable, automated insulin pump
- Diabetes patients could soon replace fingersticks with Senseonics implantable CGM
- Abbott touts real-world CGM data at diabetes conference
- Could this agreement boost continuous glucose monitor use?
- 7 MD&M East exhibitors you need to know
- Dexcom, Companion Medical will share glucose, insulin data
- Senseonics touts strong safety profile in long-term Eversense CGM post-market registry study
- Companion Medical, Glooko ink InPen insulin pen data integration deal
- U.K. says doctors should limit use of paclitaxel devices
- Blood glucose monitor dev Intuity Medical raises $26m
- Valeritas touts ADA’s inclusion of patch-like insulin delivery devices in diabetes management guidelines
- Beta Bionics starts new trial for bionic pancreas
Clinical Trials
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 […]
Senseonics touts strong safety profile in long-term Eversense CGM post-market registry study
Senseonics (NYSE:SENS) said yesterday that is presenting long-term safety data on its Eversense CGM from a European post-market clinical follow up registry later this week, touting that results showed the device as having a strong safety profile. The presentation is slated to take place this Saturday as part of the American Diabetes Association’s Scientific Sessions in […]
Windtree, Eleison tout feasibility study results
Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in […]
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