AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
U.S. should have enough COVID-19 vaccine by Q3 2021, CDC head tells Senate panel
CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to […]
Feds unveil COVID-19 vaccine distribution plan
The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include: Healthcare personnel likely to be exposed to or treat […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind. Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between […]
Report: China begins testing COVID-19 nasal spray vaccine
China has reportedly begun human testing for a COVID-19 vaccine which utilizes nasal spray instead of an injection. A report in Bloomberg cites a registration in the Chinese Clinical Trial Registry confirming that the nasal spray vaccine candidate developed by Xiamen University, Hong Kong University and Beijing Wantai Biological Pharmacy Enterprise is undergoing Phase I […]
AstraZeneca puts COVID-19 vaccine trial on hold
AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness. The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III […]
Enable Injections completes $25M credit facility
Enable Injections announced today that it completed a credit facility worth $25 million from Oxford Finance LLC. Cincinnati-based Enable Injections said in a news release that the funds are earmarked for supporting the scaling of high-volume manufacturing and the achievement of major inflection points as it moves toward commercialization. Get the full story at our sister […]
Boston Scientific stent gains added Medicare coverage
Boston Scientific (NYSE:BSX) announced today that CMS granted a new technology add-on payment (NTAP) for its Eluvia system. Marlborough, Mass.-based Boston Scientific’s Eluvia drug-eluting vascular stent system received the NTAP as part of the 2021 inpatient prospective payment system (IPPS). The NTAP will be made effective on Oct. 1, 2020, to provide eligible hospitals with incremental […]
Abbott launches trial for drug-eluting resorbable scaffold
Abbott (NYSE:ABT) announced today that it started the LIFE-BTK clinical trial for its Espirit BTK everolimus-eluting resorbable scaffold system. According to a news release, Abbott’s Espirit system is the first to begin an investigational device exemption (IDE) trial in the U.S. for a fully resorbable device for treating below-the-knee blocked arteries or critical limb ischemia (CLI) […]
Abbott wins Medicare reimbursement for FreeStyle Libre 2
Abbott (NYSE:ABT) announced today that its next-generation FreeStyle Libre 2 iCGM is now available to Medicare patients. The integrated continuous glucose monitoring (iCGM) system met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), making it accessible to all Medicare patients with diabetes who meet the […]
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