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The US Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.
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In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronovarus Treatment Acceleration Programme, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering the approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population.
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The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated.
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The trial looked at 1,062 hospitalized subjects with mild, moderate, and severe COVID-19 who received Veklury or placebo, plus standard of care.
Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.
The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.
A second randomized, open-label multi-center clinical of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days with the standard of care.
Want to read more in Hindi? Checkout: भारत के गलत मानचित्र को लेकर सरकार ने ट्विटर को दी चेतावनी.
Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group on Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group, when compared to those receiving only standard of care, were numerically favorable, but not statistically significantly different.
A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days.
Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.
Possible side effects include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. (IANS)
SAN FRANCISCO — Facebook critics pounced Wednesday on a report that the social network plans to rename itself, arguing it may be seeking to distract from recent scandals and controversy.
The report from tech news website The Verge, which Facebook refused to confirm, said the embattled company was aiming to show its ambition to be more than a social media site.
But an activist group calling itself The Real Facebook Oversight Board warned that major industries like oil and tobacco had rebranded to "deflect attention" from their problems.
"Facebook thinks that a rebrand can help them change the subject," said the group's statement, adding the real issue was the need for oversight and regulation.
Facebook spokesman Andy Stone told AFP: "We don't have any comment and aren't confirming The Verge's report."
The Verge cited an unnamed source noting the name would reflect Facebook's efforts to build the "metaverse," a virtual reality version of the internet that the tech giant sees as the future.
Facebook on Monday announced plans to hire 10,000 people in the European Union to build the metaverse, with CEO Mark Zuckerberg emerging as a leading promoter of the concept.
The announcement comes as Facebook grapples with the fallout of a damaging scandal, major outages of its services and rising calls for regulation to curb its vast influence.
The company has faced a storm of criticism over the past month after former employee Frances Haugen leaked internal studies showing Facebook knew its sites could be harmful to young people's mental health.
The Washington Post last month suggested that Facebook's interest in the metaverse is "part of a broader push to rehabilitate the company's reputation with policymakers and reposition Facebook to shape the regulation of next-wave internet technologies."
Silicon Valley analyst Benedict Evans argued a rebranding would ignore fundamental problems with the platform.
"If you give a broken product a new name, people will quite quickly work out that this new brand has the same problems," he tweeted.
"A better 'rebrand' approach is generally to fix the problem first and then create a new brand reflecting the new experience," he added.
Google rebranded itself as Alphabet in a corporate reconfiguration in 2015, but the online search and ad powerhouse remains its defining unit despite other operations such as Waymo self-driving cars and Verily life sciences. (VOA/RN)
Keywords: Facebook, Renaming, Fallout, Verge
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Scientists temporarily attached a pig's kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for lifesaving transplants.
Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack.
Surgeons attached the pig kidney to a pair of large blood vessels outside the body of a deceased recipient so they could observe it for two days. The kidney did what it was supposed to do — filter waste and produce urine — and didn't trigger rejection.
"It had absolutely normal function," said Dr. Robert Montgomery, who led the surgical team last month at NYU Langone Health in New York. "It didn't have this immediate rejection that we have worried about."
This research is "a significant step," said Dr. Andrew Adams of the University of Minnesota Medical School, who was not part of the work. It will reassure patients, researchers and regulators "that we're moving in the right direction."
The dream of animal-to-human transplants, or xenotransplantation, dates to the 17th century with stumbling attempts to use animal blood for transfusions. By the 20th century, surgeons were attempting transplants of organs from baboons into humans, notably Baby Fae, a dying infant, who lived 21 days with a baboon heart.
With no lasting success and much public uproar, scientists turned from primates to pigs, tinkering with their genes to bridge the species gap.
Pigs have advantages over monkeys and apes. They are produced for food, so using them for organs raises fewer ethical concerns. Pigs have large litters, short gestation periods and organs comparable to those of humans.
Pig heart valves also have been used successfully for decades in humans. The blood thinner heparin is derived from pig intestines. Pig skin grafts are used on burns, and Chinese surgeons have used pig corneas to restore sight.
Kidney ready for transplantation from a live donor Image credit: wikimedia commons
In the NYU case, researchers kept a deceased woman's body on a ventilator after her family agreed to the experiment. The woman had wished to donate her organs, but they weren't suitable for traditional donation.
'Good could come from this'
The family felt "there was a possibility that some good could come from this gift," Montgomery said.
Montgomery himself received a transplant three years ago, a human heart from a donor with hepatitis C because he was willing to take any organ.
"I was one of those people lying in an ICU waiting and not knowing whether an organ was going to come in time," he said.
Several biotech companies are in the running to develop suitable pig organs for transplant to help ease the human organ shortage. More than 90,000 people in the U.S. are in line for kidney transplants. Every day, 12 die while waiting.
The advance is a win for Revivicor, a subsidiary of United Therapeutics, the company that engineered the pig and its cousins, a herd of 100 raised in tightly controlled conditions at a facility in Iowa.
The pigs lack a gene that produces alpha-gal, the sugar that provokes an immediate attack from the human immune system.
In December, the Food and Drug Administration approved the gene alteration in the Revivicor pigs as safe for human food consumption and medicine.
But the FDA said developers would need to submit more paperwork before pig organs could be transplanted into living humans.
"This is an important step forward in realizing the promise of xenotransplantation, which will save thousands of lives each year in the not-too-distant future," said United Therapeutics CEO Martine Rothblatt in a statement.
Experts say tests on nonhuman primates and last month's experiment with a human body pave the way for the first experimental pig kidney or heart transplants in living people in the next several years.
Raising pigs to be organ donors feels wrong to some people, but it may grow more acceptable if concerns about animal welfare can be addressed, said Karen Maschke, a research scholar at the Hastings Center, who will help develop ethics and policy recommendations for the first clinical trials under a grant from the National Institutes of Health.
"The other issue is going to be: Should we be doing this just because we can?" Maschke said. (VOA/RN)
Keywords: Transplant, Pig, Human, Kidney, FDA
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Developed by the Indian Institute of Tropical Meteorology (IITM), Pune, a Decision Support System (DSS) that extends the ability of the existing air quality early warning system (AQEWS) to have decision-making capability for air quality management in Delhi-NCR was launched on Tuesday.
The website for the DSS (https://ews.tropmet.res.in/dss/) is designed to help the Commission for Air Quality Management for NCR and Adjoining Areas (CAQM) by delivering quantitative information about the contribution of emissions from Delhi and its 19 surrounding districts; the contribution of emissions from eight different sectors in Delhi; and the contribution from biomass-burning activities in the neighbouring states.
These information would assist in managing the air quality in a timely manner, a release from the Ministry of Earth Sciences said.
The need was stated by the CAQM, which was formed by the Ministry of Environment, Forest and Climate Change, during a meeting held in January 2021.
Recently, the Commission reviewed the progress made by IITM and had in principle approved the current version of DSS for air quality management in the Delhi-NCR. The IITM has also developed a new website for DSS with the entire system made operational, the release said.
Union Minister of State for Earth Sciences, Jitendra Singh, while launching the website for AQEWS on the occasion of 'Azadi Ka Amrit Mahotsav' week organised by the Ministry of Earth Sciences, said, "DSS is a significant contribution to 'Azadi Ka Amrit Mahotsav' on behalf of MoES and IITM and suggestions are invited on this issue."
The website also has a feature whereby the users can create their own emission reduction scenarios (from 20 different districts, including Delhi) so as to examine the possible projected improvement in air quality in Delhi for the next five days.
"This information would explicitly highlight the most important emission sources responsible for the degradation of air quality in Delhi and suggest possible solutions to ameliorate the same. With a plethora of quantitative data, the AQEWS integrated with DSS could become a user-friendly tool for air-quality management in and around Delhi," the release said. (IANS/JB)
Keywords: Delhi, India, Pollution, IITM, Ministry of Earth Sciences