covid-19 Archives - Page 38 of 113 - Medical Design Sourcing

Roche wins EUA for intravenous tocilizumab in treating COVID-19

Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19.

Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

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

Roche wins EUA for intravenous tocilizumab in treating COVID-19

Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19.

Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Actemra/RoActemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief, Roche said in a news release.

According to the release, Roche garnered authorization based on results from four randomized, controlled studies eva…

COVID-19 vaccinations continue to decline in the U.S.

[Photo by Daniel Schludi on Unsplash]

The pace of COVID-19 vaccination in the U.S. continues to fall. Today, the U.S. administered about 600,000 COVID-19 vaccine doses, which is far fewer than two months ago.

At the mid-April peak, healthcare workers administered more than 3 million COVID-19 vaccine doses. The pace of vaccination fell steadily from that time to early June before stabilizing at around 1 million doses per day.

Complicating matters is the spread of the Delta variant (B.1.617.2), which ravaged India. The variant is now dominant in the U.K. and Europe, threatening to undermine the return to normalcy there.

According to a preprint study, the Delta variant could become dominant in the U.S. within a matter of weeks. Indeed, the variant already is the cause of almost half of COVID-19 infections in some Midwest and mountain states, said CDC Director Dr. Rochelle Walensky in a briefing on …

No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …

FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.

The conditions appear to be more common in males.

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care.

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

RedHill Biopharma announces positive data for oral COVID-19 drug

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced positive results from a Phase 2 U.S. study involving its opaganib in hospitalized COVID-19 patients with pneumonia.

The study indicated that opaganib reduced the need for supplemental oxygen therapy and an earlier hospital discharge. RedHill also concluded that the drug was well-tolerated based on the placebo-controlled Phase 2 study, which involved 40 patients in the U.S.

The experimental drug inhibits sphingosine kinase-2 (SK2), an enzyme that plays a role in inflammation and replication of some viruses. Opaganib thus has dual antiviral and anti-inflammatory modes of action.

A total of 50% of opaganib recipients could breathe without ventilator support within 14 days of treatment compared to 22% of people in the placebo group.

Some 86.4% of patients receiving opaganib were able to leave the hospital within 14 days compared with 55.6% of placebo recipients.

The study anticipates that th…

Europe orders another 150 million doses of Moderna’s COVID-19 vaccine

Moderna (NSDQ:MRNA) has announced that the European Commission has reserved an additional 150 million doses of its COVID-19 vaccine for delivery in 2022.

To date, the European Commission has reserved 460 million Moderna vaccine doses.

The new deal gives the European Commission the ability to purchase new COVID-19 vaccines.

The company is currently testing various booster options, including the use of its existing mRNA-1273 vaccine. In addition, it is developing a vaccine known as mRNA-1273.351 based on the B.1.351 variant that first emerged in South Africa.

Interim data from a Phase 2 trial in the U.S. found that both mRNA-1273 and mRNA-1273.351 led to increased neutralizing antibody titer levels in response to the B.1.351 and P.1 variants. The mRNA-1273.351 appears to be more effective at generating an immune response to those viral lineages. The P.1 variant is also known as the “Gamma Variant.”

Moderna also recently announced that the…

Could the controversial drug ivermectin save lives?

[Photo by Fusion Medical Animation on Unsplash]

The antiparasitic drug ivermectin holds promise as a COVID-19 treatment, according to a new study published in the American Journal of Therapeutics. The study authors conclude that ivermectin could reduce the risk of COVID-19-related death with moderate-certainty evidence. “Using ivermectin early in the clinical course may reduce numbers progressing to severe disease,” they conclude, adding that the drug is “likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

The meta-analysis analyzed databases up to April 2021, drawing from 24 randomized controlled trials with 3,406 patients.

Another study published in Lancet found a concentration-dependent antiviral activity of oral high-dose ivermectin in a trial involving 45 patients.

Many experts, however, have voiced skepticism regarding the use of ivermectin as a COVID-19 treatment.…

White House allocates 55M COVID-19 vaccine doses for global distribution

[Photo by Daniel Schludi on Unsplash]The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

Get the full story at our sister site, Pharmaceutical Processing World.

White House to allocate 55M COVID-19 vaccine doses for global distribution

The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

According to a news release, the U.S. will share 75% of the 80 million through COVAX and 25% are earmarked to help with surges around the world. The doses are slated to be allocated based on national vaccine plans, prioritizing those most at risk, including healthcare workers.

The allocation plan for the 55 million doses announced today includes 41 million to be shared through COVAX, with 14 million for Latin America and the Caribbean, with doses going to Brazil, Argentina, Brazil, Arge…

Australia COVID-19 vaccine supply limited until August

Australia image from Pixabay.

As the U.S. sees demand plateauing for COVID-19 vaccines, Australia is facing a shortage of both vaccine supplies and healthcare workers.

Australian health officials project that the nation’s vaccination program will face delays from June to July. The slowdown is partly a result of limited shipments of the Pfizer vaccine. Australia expects to receive 1.7 million doses of the vaccine this month and another 2.8 million in July.

Australian officials are also aiming to enlist a greater number of general practitioners to help dispense vaccines later in the summer when supplies are likely to increase.

Like several other countries, Australia has also limited the use of the AstraZeneca (LON:AZN) vaccine over the risk of rare blood clots. Health officials there recently recommended the AstraZeneca vaccine only for adults 60 and older.

Australia’s Chief Medical Office…