FDA extends approval of remdesivir to encompass non-hospitalized high-risk

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020.

Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe COVID-19, including hospitalization or death.

The drug was formerly approved for hospitalized adults and children in a hospital or healthcare setting capable of offering similar care. Now, it can be administered in some outpatient settings.

FDA also expanded the emergency use authorization of the drug for non-hospitalized children younger than 12 with a high risk of disease progression.

Demand has surged for COVID-19 therapies, including remdesivir that retain efficacy against the omicron variant of SARS-CoV-2.

Gilead first discovered and developed remdesivir in 2009 as a investigati…

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Medtronic’s recall of HawkOne system is Class I

The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.

So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.

Get the full story at our sister site, MassDevice.

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Medtronic’s recall of HawkOne system is Class I

The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.

So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.

The latest recall covers 95,110 HawkOne directional atherectomy systems in the U.S. that were distributed between Jan. 22, 2018, and Oct. 4, 2021. Medtronic initiated the recall on Dec. 6, 2021, having received 163 complaints and 55 reports of injuries with no deaths reported related to the issue.

Medtronic designed HawkOne with a catheter and a cutter driver for use during procedures intended to remove blockage from peripheral arteries and improve blood flow. The rec…

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FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set

Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology.

Irvine, California–based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability.

Get the full story at our sister site, Drug Delivery Business News.

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Sensydia wins FDA breakthrough nod to expand uses for its cardiac monitoring device

[Image from Sensydia]Sensydia announced today that it received FDA breakthrough device designation for its Cardiac Performance System (CPS).

Los Angeles-based Sensydia designed CPS as a non-invasive cardiac monitoring device that reports critical heart performance measurements to physicians for the comprehensive evaluation of patients with advanced and persistent heart failure. It can make the measurements without an in-hospital catheterization procedure or ultrasound assessment, according to the company

CPS already has FDA clearance for measuring ejection fraction — and can presently measure cardiac output, pulmonary artery pressure and pulmonary capillary wedge pressure simultaneously.

According to a news release, CPS uses ultra-sensitive biosensors to acquire heart sound data before applying machine learning to compute multiple hemodynamic measurements. The platform then delivers a comprehensive all-in-one report through its CPS iPad application.

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FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer

FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY).

The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen.

FDA also granted priority review to the application.

In 2019, Enhertu first won FDA approval for HER2-positive unresectable or metastatic breast cancer after two or more prior anti-HER2-based regimens.

Two years later, the agency extended approval to patients with previously-treated HER2-positive advanced gastric cancer.

The recent application includes data from the DESTINY-Breast03 study,

That study found that Enhertu demonstrated a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla…

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NeuroMetrix’s Quell wins FDA breakthrough designation to treat certain chemo side effects

[Image from NeuroMetrix]

NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology.

Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy.

Get the full story at our sister site, MassDevice.

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NeuroMetrix’s Quell wins FDA breakthrough designation to treat certain chemo side effects

The Quell wearable pain relief device [Image courtesy of NeuroMetrix]NeuroMetrix (NSDQ:NURO) announced today that it received FDA breakthrough device designation for its Quell technology.

Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy.

NeuroMetrix designed Quell as a wearable, non-invasive neuromodulation technology enabled by a proprietary microchip. The device automatically adjusts stimulation through position and motion sensing while supporting Bluetooth low energy (BLE) to communicate with smartphone and smartwatch apps to allow for control and personalization of the treatment.

The company earned the breakthrough designation through the submission of results from a six-week open-label study that evaluated Quell’s safety and effectiveness in 2…

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Ahead of G7 launch, Dexcom CEO plans for ‘more activity than we’ve ever seen’ in 2022

With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022.

Across 2021, Dexcom (NSDQ:DXCM) took several steps forward.

The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a major regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple.

As the new year gets underway, expectations for the coming year have been set even higher.

“2022 holds about more activity than we’ve ever seen in a given year,” Sayer told Drug Delivery Business News. “It’s going to be a year of many of the same activities, but some very big advances on the product front. And then, once we get the hardware platforms out there, we’re hopeful we can then start coming up with several software solutions that are going to be different than what we’ve had in the past. It’s going to be a fun year.”

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FDA grants new drug approval to Glenmark’s rhinitis-treating nasal spray

Glenmark Pharmaceuticals announced today that it received FDA approval for a new drug application (NDA) for Ryaltrais.

Ryaltris, a fixed-dosed, prescription drug product nasal spray treats symptoms of seasonal allergic rhinitis in adults and pediatric patients over 12 years of age in the U.S.

Glenmark’s fully owned subsidiary, Glenmark Specialty S.A. (Switzerland), received the NDA approval for Ryaltris.

Get the full story at our sister site, Drug Delivery Business News.

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American College of Clinical Pharmacology cautions against widespread off-label use of ketamine

3d model of Ketamine from Wikimedia Commons

Interest in the dissociative anesthetic ketamine is surging, given its potential to treat treatment-resistant depression and other mental health disorders.

Against that backdrop, the American College of Clinical Pharmacology (ACCP) have released two policy statements advocating for stricter use of the drug. In addition, ACCP is arguing against its use in non-medical settings such as law-enforcement contexts where the drug is used as a forced sedative.

One of the ACCP statements concludes that the drug has an unfavorable risk–benefit profile. The ACCP observes that not only does ketamine have a significant potential for abuse, it has been linked to drug-drug interactions that could pose a safety risk.

Furthermore, the drug can lead to elevations in blood pressure and pulse. As a result, ACCP suggests that a licensed physician with advanced life support…

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Abbott wins FDA clearance for new cardiac mapping system

Abbott (NYSE:ABT) announced today that it received FDA clearance for its EnSite X EP with EnSite Omnipolar technology (OT).

The company designed the new cardiac mapping platform, now available in the U.S. and across Europe, to help physicians better treat abnormal heart rhythms (cardiac arrhythmias).

EnSite X EP creates highly detailed, three-dimensional maps of the heart to help physicians identify then treat areas of the heart where abnormal rhythms originate, according to a news release. The system includes Abbott’s proprietary EnSite OT, which uses the Advisor HD grid catheter to provide true electrograms (EGMs) regardless of how the catheter is oriented within the heart.

The ability to sample EGMs in 360 degrees allows the EnSite X EP system with EnSite OT to map 1 million points in the heart and provide a more precise location for treatment areas, Abbott said.

Abbott designed the platform to be upgradable via new software to ensure acc…

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