coronavirus Archives - Page 90 of 99 - Medical Design Sourcing

HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials

The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines.

The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials Science.

Under the Trump Administration’s “Operation Warp Speed,” HHS and DoD plan to scale up domestic manufacturing capacity for the vials that could be needed for vaccines and drugs in response to the ongoing COVID-19 pandemic, as well as future public health emergencies, according to a news release.

BARDA is partnering with and offering $204 million to Corning in return for manufacturing capacity expansion to produce an additional 164 million Valor glass vials each year if needed. Corning will accelerate manufacturing at its facilities in Durham, N.C., Big Flats, N.Y…

FDA issues warning letters to companies selling antibody tests

The FDA announced that it issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.

Medakit, Antibodiescheck.com and Yama Group and Dr. Jason Korkus, DDS & Sonrisa Family Dental d/b/a My COVID19 Club all received warnings.

In the warnings, the agency outlined violations including offering test kits for sale in the U.S. directly to consumers for at-home use without marketing approval, clearance or authorization from the FDA. The letters also noted misbranding by claiming that products are “FDA-approved” and labeling that bears the FDA logo, which is not meant for use on private sector materials.

The FDA said in a news release that there are no diagnostic or antibody COVID-19 test kits that are authorized to be used completely at home, but there are tests for use with at-home sample collection followed by processing and reporting at a laboratory.

Violators are urged to take immediate …

Beckman Coulter wins CE Mark for COVID-19 antibody test

Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe.

Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the globe. It already has more than 16,000 immunoassay analyzers worldwide and ramped up its manufacturing to deliver more than 30 tests per month.

Get the full story at our sister site, Drug Discovery & Development.

Beckman Coulter wins CE Mark for COVID-19 antibody test

Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe.

Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the globe. It already has more than 16,000 immunoassay analyzers worldwide and ramped up its manufacturing to deliver more than 30 tests per month.

The Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG) and targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein when testing for the virus causing COVID-19. The company will be seeking CE Mark approval for its Access SARS-CoV-2 IgM assay in the near future as well.

“Our assay has the potential to identify individuals who have already mounted an immune response to the novel coronavirus and could donate convalescent plasma for use i…

FDA revokes EUA for COVID-19 antibody test

The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns.

Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer results within 15 minutes.

As it was one of the first antibody tests authorized by the FDA during the COVID-19 pandemic, the agency concluded at the time that it met the statute’s “may be effective” standard for EUA, with the test’s known and potential benefits outweighing its known and potential risks.

However, the agency has since learned more regarding performance capabilities for SARS-CoV-2 serology tests, according to a news release, and developed general performance expectations for these tests.

Data submitted by Chembio showed that its test generates a…

CAE receives Health Canada nod for CAE Air1 ventilator

The CAE Air1 ventilator (CNW Group/CAE INC.)

CAE (NYSE:CAE) announced today that its CAE Air1 ventilator received certification from Health Canada and is set to treat people with COVID-19.

Two months ago, the Canadian government issued a contract to CAE to manufacture and supply 10,000 ventilators amid the COVID-19 pandemic. The devices deliver pressure control, volume control and pressure support ventilation using room air or pressured oxygen.

The CAE Air1 ventilator includes an intuitive touchscreen interface and is bundled with on-demand ventilator training, adaptive e-learning modules related to COVID-19 patient management and 24/7 customer support.

Montreal-based CAE said in a news release that it will begin shipping hundreds of CAE Air1 machines to the Canadian government every week.

“Since the beginning of the pandemic, CAE was the first to receive certification from Heal…

Researchers identify potent antibody cocktail to treat COVID-19

Researchers at the University of Maryland School of Medicine (UMSOM) said they identified a promising anti-viral cocktail therapy against COVID-19.

According to a news release, the researchers evaluated several human antibodies to determine the most potent combination to be mixed and used against SARS-CoV-2, the virus causing COVID-19. In collaboration with Regeneron Pharmaceuticals (NSDQ:REGN), UMSOM published results of a study in Science.

Just last week, Regeneron announced that it had initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19, having already used the same “rapid response” approach to develop its REGN-EB3 antibody treatment for Ebola that is under review by the FDA.

The research was conducted using Regeneron’s proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19. Researchers selected the most potent antibo…

CEO Kevin Lobo says Stryker ready to regain lost momentum

Stryker CEO Kevin Lobo (Image from Stryker)

Stryker (NYSE:SYK) CEO Kevin Lobo said today that the company is preparing to restart “a number” of idled production lines next month as it climbs out the crater created by COVID-19.

In an interview on the DeviceTalks Weekly Podcast, Lobo said the company is rebounding from its low point in April, when its sales fell almost 40%.

“May was better than April. And June is tracking to be better than May,” Lobo said. “As the economies open up, business is starting to return, which is very exciting.”

Just over 40% of Stryker’s $14.9 billion in revenue comes from sales of hip, knee, spine and other related procedures, according to its 2019 annual report. In the deepest days of the pandemic, these elective procedures were cancelled so hospitals could commit resources to treating coronavirus patients while also limiting the risk of exposing non-Covid-19 patient…

Oxford researchers find widely available steroid reduces COVID-19 deaths

Oxford researchers announced today that, following testing with thousands of patients, dexamethasone may improve patient survival in cases of COVID-19.

Dexamethasone is a corticosteroid commonly used for treating arthritis and other cases of inflammation. In total, 2,104 patients were randomized in Oxford’s trial to receive dexamethasone in doses of 6 mg, once per day, either by mouth or intravenous injection, over the course of 10 days.

Get the full story at our sister site, Drug Discovery & Development.

Oxford researchers find widely available steroid reduces COVID-19 deaths

[Image courtesy of CDC]

Oxford researchers announced today that, following testing with thousands of patients, dexamethasone may improve patient survival in cases of COVID-19.

Dexamethasone is a corticosteroid commonly used for treating arthritis and other cases of inflammation. In total, 2,104 patients were randomized in Oxford’s trial to receive dexamethasone in doses of 6 mg, once per day, either by mouth or intravenous injection, over the course of 10 days.

The patients receiving the steroid were compared with 4,321 patients randomized to receive usual care alone. Among the usual care patients, 28-day mortality was highest in those who required ventilation (41%), intermediate in patients only requiring oxygen (25%) and lowest among those who did not require respiratory intervention (13%).

According to a news release, dexamethasone reduced deaths by one-third in ventilated patients and …

States reportedly fend for themselves with inflated ventilator prices

The Puritan Bennett 560 (PB 560) ventilator [Image courtesy of Medtronic]

States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report.

Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam in March. Kaiser’s report noted that White House officials, such as senior adviser (and President Donald Trump’s son-in-law) Jared Kushner, claimed the federal stockpile was not meant for the states, leaving them to track down ventilators elsewhere.

As the Trump administration sought to replenish its own supply of ventilators, officials from a number of states have said that they ordered millions of dollars’ worth of machines from private companies, sometimes bidding against the fed…

FDA revokes EUA for malaria drugs against COVID-19

FDA today announced that it has revoked its emergency use authorization allowing doctors to use the malaria drugs hydroxychloroquine and chloroquine to treat COVID-19, citing concerns about the drugs’ safety and efficacy against the virus.

A large, randomized clinical trial in hospitalized patients found the malaria medicines showed no benefit for decreasing the likelihood of death or speeding recovery, according to FDA. Said FDA: “This outcome was consistent with other new data, including those showing the suggested dosing for these medicines are unlikely to kill or inhibit the virus that causes COVID-19.”

President Donald Trump had previously touted the potential for the malaria drugs to treat the coronavirus, even disclosing that he himself was taking hydroxychloroquine preemptively after coming in contact with people who tested positive for the virus.

There has never been high-quality…