A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in … [Read More...] about Abbott touts Xience DES study results
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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...] about Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Featured Posts
Dexcom down big despite strong Q3, raised guidance
Dexcom (NSDQ:DXCM) shares took a big hit today on third-quarter results that trounced the consensus forecast. Shares of DXCM were down nearly -9% at $346.51 per share in mid-morning trading yesterday. Today, DXCM is trading down -3.2% … [Read More...] about Dexcom down big despite strong Q3, raised guidance
Baxter has a serious infusion pump recall
Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports … [Read More...] about Baxter has a serious infusion pump recall
What you need to know about analytical testing for drug-device combinations
Pharmaceutical manufacturers need to understand the compatibility and performance of the primary packaging system with both the drug and its delivery system. Jennifer Riter, West Pharmaceutical As more pharmaceutical manufacturers develop … [Read More...] about What you need to know about analytical testing for drug-device combinations
West Pharmaceuticals dips despite strong Q3, raised guidance
West Pharmaceutical Services (NYSE:WST) shares dipped slightly despite third-quarter results that topped the consensus forecast. The Exton, Pa.-based company posted profits of $82.3 million, or $1.09 per share, on sales of $548 million for the … [Read More...] about West Pharmaceuticals dips despite strong Q3, raised guidance
Amazon, Onica to support digital health for Teva’s Digihaler
Teva Respiratory (NYSE:TEVA) announced that it is collaborating with Amazon Web Services (AWS) and Onica to build and host its digital health platform. The Teva Pharmaceuticals affiliate's digital health platform is a cloud-based backend data … [Read More...] about Amazon, Onica to support digital health for Teva’s Digihaler
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in … [Read More...] about Abbott touts Xience DES study results
Dexcom, Lilly partner on diabetes management for healthcare providers
Eli Lilly (NYSE:LLY) and Dexcom (NSDQ:DXCM) today announced a joint program for U.S. healthcare providers that includes Lilly's new, rapid-acting Lyumjev mealtime insulin pen and Dexcom G6 continuous glucose monitoring (CGM) systems. The program … [Read More...] about Dexcom, Lilly partner on diabetes management for healthcare providers
HHS gives Vaxxas $22M to support vaccine patch tech
Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company's vaccine-delivery patch. The money will mostly … [Read More...] about HHS gives Vaxxas $22M to support vaccine patch tech
Delcath names new CEO
Delcath Systems (OTC:DCTH) announced that it appointed Gerard Michel as its new CEO, effective yesterday, Oct. 1, 2020. Michel assumed the role yesterday and also was appointed as a Class I director on the company’s board of directors, with that … [Read More...] about Delcath names new CEO
Abbott’s FreeStyle Libre 3 receives CE Mark
Abbott (NYSE:ABT) has won the CE Mark in the European Union for its next-generation FreeStyle Libre 3 continuous glucose monitoring system. Officials at Abbott boast that the Libre 3 technology includes a super small, thin sensor. It's the size of … [Read More...] about Abbott’s FreeStyle Libre 3 receives CE Mark
In case you missed it
- Teva launches 2 digital inhalers in U.S.
- Report: China begins testing COVID-19 nasal spray vaccine
- Thermo Fisher to manufacture Inovio COVID-19 vaccine candidate
- Enable Injections completes $25M credit facility
- Could Vaxxas’ tiny patches enable a better COVID-19 vaccine?
- Abbott wins Medicare reimbursement for FreeStyle Libre 2
- FDA approves Medtronic MiniMed 770G insulin pump for young children
- Study: Medtronic’s drug-coated balloon reduces dialysis interruptions
- CureVac stock soars after $213.3M IPO
- Nemaura Medical dips on Q1 losses
- PerkinElmer launches high-volume COVID-19 test workstations
- BREAKING: Thermo Fisher drops bid for Qiagen
- Medtronic to acquire Companion Medical, expands diabetes business
- Report: Will Dr. Hahn crack under political pressure?
- 3M lays off another 1,700 workers, many related to former drug delivery business
Clinical Trials
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]
TriSalus names new chief medical officer
TriSalus today said it appointed Steven Katz as chief medical officer. Katz will be responsible for overseeing the company’s clinical development strategy in the treatment of solid tumors. He has served as TriSalus’s chief medical advisor and chairperson of its scientific advisory board since 2018. “We are thrilled to have Steven join TriSalus as a […]
Thermo Fisher to manufacture Inovio COVID-19 vaccine candidate
Inovio Pharmaceuticals (NSDQ:INO) announced that Thermo Fisher Scientific (NYSE:TMO) will manufacture its COVID-19 vaccine candidate. Plymouth Meeting, Pa.-based Inovio said in a news release yesterday that Thermo Fisher signed a letter of intent to manufacture the INO-4800 COVID-19 vaccine candidate, joining a consortium of third-party manufacturers that aim to produce 100 million doses of Inovio’s vaccine by […]
Study: Medtronic’s drug-coated balloon reduces dialysis interruptions
Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment. Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can […]
Inovio to scale up production of smart delivery device for potential COVID-19 vaccine
Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device. Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the procurement of Cellectra 2000 devices, which are used to deliver Inovio’s INO-4800 COVID-19 vaccine candidate directly into the skin. […]
