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The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.
The Food and Drug Administration will make a decision on whether to fully approve Eisai and Biogen 's Alzheimer's treatment Leqembi by July 6, the companies announced Monday. It is administered intravenously twice a month and slowed the progression of early Alzheimer's disease by 27% in clinical trials. Although the FDA approved Leqembi on an expedited basis in January, access to the treatment is virtually nonexistent right now. Learn more and register today: http://bit.ly/3DUNbRoThe Alzheimer's Association called on CMS in December to provide unrestricted coverage of treatments like Leqembi. "As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary," the agency said in its statement.
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.
LONDON, Feb 16 (Reuters) - Britain's agency that determines if medicines should be used in the National Health Service (NHS) said on Thursday it is speeding up how it decides if COVID-19 therapies are still effective against circulating variants. The new review process will enable the agency to update its recommendations on the cost-effectiveness of COVID treatments so they can be made available more swiftly to patients, it said. "The rapidly evolving nature of COVID-19 means we need to have a way of establishing the cost effectiveness of existing medicines against current variants in an agile way," the National Institute for Health and Care Excellence (NICE) said. It said there is no evidence of Evusheld's clinicial effectiveness against current variants and those likely to be circulating in the next 6 months. The announcement comes as demand for COVID treatments appears set to drop this year, due to population immunity from high rates of vaccination and previous infections.
Today, Compass Pathways, the for-profit company they launched in 2016, is a Nasdaq-listed firm worth about $400 million. Compass Pathways Show lessIt could also boost the dozens of psychedelics companies inspired by Compass that have been formed in recent years. Insider spoke with more than a dozen industry participants to chart the rise of Compass Pathways and its role in the psychedelics boom. He recalled the 2018 Quartz article that detailed the growing alarm around Compass Pathways' "magic mushroom monopoly." Were it not for his decision to take a break from college, and his parents' efforts to find a treatment, Compass Pathways might not exist.
Digital twins are set for rapid adoption in 2023
  + stars: | 2023-01-21 | by ( Bob Violino | ) www.cnbc.com   time to read: +7 min
This avatar is a personalised, hyper-realistic, 3D, #seriezero digital twin that they can use to interact on digital platforms and in the metaverse. In life sciences, digital twins are being used to create twins of human organs, enabling new approaches to medical research and care, Diana said. "We are going to see digital twins adopted rapidly in 2023, in many different industries," Diana said. Digital twins are gaining momentum in adoption and sophistication as more organizations see positive outcomes from the early adopters, Barrington said. "As more twins of critical assets and processes come online, leaders will leverage digital twins to not only model and simulate their supply chain, but to optimize and automate a dynamic and intelligent supply chain model — all orchestrated by digital twins," Barrington said.
Both companies have released results from RSV vaccine trials with efficacy results strong enough to expect expedited approval from the FDA. The companies — which have been involved in litigation brought by Moderna alleging mRNA patent infringement, a claim Pfizer disputes — are both expected the FDA approval process for the RSV vaccine to occur soon. We can use the same, the same equipment and raw materials as the Covid vaccine." The RSV approval process is just one part of a widening vaccine industry for these two companies. "Every strain is treated as suspicious and we start working on it to see if it can overcome the vaccine," Bourla said.
The importance of addressing climate change has never been greater. No single business or organization can tackle climate change on its own. On the first day of Climate Week NYC, industry experts gathered to discuss what's stopping us from getting climate action done. Helping small and medium-sized customers optimize their climate efforts allows companies with the resources and reach of Hitachi to extend climate action beyond their current offerings. Discover how Hitachi is getting it done by driving climate action through its sustainable technologies and solutions.
China needs to move past political considerations and look at importing Covid-19 jabs to end the pandemic globally, according to the chief executive of the world's latest vaccine manufacturer. The main Covid vaccines approved for use in China are from Sinovac and Sinopharm. These jabs are less effective against the Omicron variant than are other mRNA vaccines, such as Pfizer and BioNTech's, several studies have found. Poonawalla said China's pandemic reaction of 2020 — which included building hospitals and infrastructure and taking precautions — showed that Beijing could respond rapidly. He stressed China's decision not to import vaccines from the U.S., India and elsewhere, which have been "very effective."
The omicron XBB.1.5 subvariant does not have any mutations known to make people sicker when they catch the virus, according to a World Health Organization risk assessment published Wednesday. The WHO said XBB.1.5 is one of the Covid subvariants that is most adept at dodging immunity from vaccination or infection. It is just as immune evasive as another subvariant in its family, XBB.1, which was the Covid variant that best dodged antibodies that block infections. The global health organization said XBB.1.5 has a growth advantage in the U.S., particularly in the Northeast, where it has rapidly become dominant. The organization said it needs more data on how fast XBB.1.5 is spreading in other countries.
The updated Covid booster shot is proving to be effective at keeping people — especially older adults — out of the hospital, according to two new studies published Friday by the Centers for Disease Control and Prevention. Full coverage of the Covid-19 pandemicBoth studies looked at the impact the updated Covid booster shot has had since it was first recommended by the CDC on Sept. 1. Those who had received the updated booster were 84% less likely to be hospitalized with Covid, compared with people who had never had the Covid vaccine. The effectiveness was nearly identical — 83% — for people who had their last Covid shot more than a year ago. "There are 28 million people over the age of 65 that are eligible for this updated booster shot but haven’t gotten it," Link-Gelles said.
U.S. regulators on Thursday cleared doses of the updated Covid-19 vaccines for children younger than age 5. Omicron-targeted booster shots made by Moderna and Pfizer already were open to everyone 5 and older. Children under 5 who already got all three Pfizer doses aren’t yet eligible for an updated booster. “Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant,” FDA vaccine chief Dr. Peter Marks said in a statement. The CDC last month released the first real-world data showing that an updated booster, using either company’s version, does offer added protection to adults.
“And the pulse oximeter is used from any age to geriatrics,” he said. The US Food and Drug Administration is mulling over next steps for the regulation of pulse oximeter devices, which may give less accurate readings for people of color. A panel of its Medical Devices Advisory Committee met in November to review clinical data on the issue. “I think of the pulse oximeter reading in the same way. Of course this can be dangerous.”Ultimately, the pulse oximeter can estimate the amount of oxygen a person has in their blood without the need for a blood sample.
The new omicron Covid boosters probably aren't very effective at preventing Covid infections and mild illness, but they will likely help keep the elderly and other vulnerable groups out of the hospital this winter, experts say. For seniors, the booster was 19% effective at preventing mild illness when administered as their fourth dose, compared to the unvaccinated. It was 23% effective against mild illness when given as their fifth dose. Though the vaccine's effectiveness against mild illness was low, people who received the boosters were better off than those who did not. Moore said people at higher risk from Covid have every reason to get a booster since it modestly increases protection.
People who got the updated booster shots after two or more shots of the original vaccine were compared to another group of people who received only two or more doses of the original vaccine. The updated booster shots performed better in preventing infections in all adult age groups, with higher vaccine efficacy seen in people who waited longer before getting the updated booster, the CDC found. He noted that studies have shown longer intervals between Covid vaccine doses can lead to higher antibody levels. Previous Covid infections may be underreported, the agency said, and low uptake of the updated boosters could have affected the results. New subvariants BQ.1.1 and BQ.1 are on the rise in the U.S., she said, and it’s unclear how the updated boosters will perform against those strains.
Jeremy Siegel said "inflation is basically over" on Thursday after October's CPI report showed lower-than-expected inflation. Siegel said investors should expect a significant year-end rally in the stock market as investors recalibrate their Fed expectations. Siegel's confidence stems from the fact that when you exclude the Fed's use of lagging housing data, inflation would actually be negative. The CPI report showed prices rising 7.7% year-over-year, and up 0.4% on a monthly basis. 2023 won't be as bad as many think," Siegel said.
San Francisco will not renew its monkeypox public health emergency declaration when it expires at the end of the month. Many experts are optimistic that, eventually, the U.S. could sometimes see no new monkeypox cases within a limited time frame. That’s unfortunately the reality of public health in the U.S., and it needs to change," Roess said. Racial inequities also persist in vaccine distribution, so Black and Hispanic people consequently make up a disproportionate share of monkeypox cases. Despite the delays and failings in the U.S., Morse said, the monkeypox outbreak "could have been a lot worse."
The authorization of Novavax's booster could significantly increase the role that its shot plays in U.S. vaccination efforts. The Centers for Disease Control and Prevention still has to give the final go ahead before pharmacies can start administering Novavax's booster. Only 35,300 people have received Novavax's shots so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far. People who received Novavax's vaccine as their primary series are also eligible for Pfizer and BioNTech's new omicron booster.
"If you are up to date with your vaccines and if you get treated if you have a breakthrough infection, your risk of dying from Covid is now close to zero," Jha told reporters at the White House. More than 300 people are still dying every day from Covid on average, according to data from the Centers for Disease Control and Prevention. Health officials are expecting Covid infections to increase in November through January as they have every fall and winter since the pandemic began, Jha said. But it's difficult to predict whether the U.S. will face another major Covid surge because the virus continues to evolve, he added. "Don't wait — get your new flu shot and your new Covid shot today," Jha said.
The data indicate that even a single dose of the vaccine provides some initial protection against infection as soon as two weeks after the shot, Walensky said. The Jynneos vaccine, manufactured by the Danish company Bavarian Nordic, is administered in two doses 28 days apart. Walensky said although the data on a single dose is promising, lab studies have demonstrated that the immune protection is highest two weeks after the second dose. "What we have right now is data on how well and how our vaccine is working after as single dose. What we don't yet have is what happens after a second dose and how durable that protection is," Walensky said.
At least 4.4 million people have received an updated Covid booster since the start of the month, according to data released Thursday by the Centers for Disease Control and Prevention. The CDC signed off on updated versions of Pfizer’s and Moderna’s booster shots on Sept. 1, and pharmacies and other vaccination sites began administering the new shots around Labor Day weekend. As of Tuesday, the U.S. had shipped more than 25 million bivalent booster doses to tens of thousands of sites. Some pharmacies reported shortages of Moderna's updated booster earlier this week. Biden administration officials have pointed to the updated boosters, however, as a critical step to pushing the U.S. out of the pandemic.
Israelul stă cel mai bine, în lume, când vine vorba despre numărul persoanelor vaccinate împotriva COVID 19, în raport cu numărul populaţiei. La capitolul doze administrate clasamentul este condus de către SUA, care au administrat până acum 205,8 milioane de doze. Pe locul doi și trei se află China, cu 188 de milioane de vaccinați și India cu 122,6. Locurile trei și patru sunt împărțite de către Marea Britanie și Bahrain cu un număr de 62 de persoane vaccinate raportat la 100. Țara noastră se clasează din păcate în cea de-a doua jumătate a clasamentului, care are doar 2,27 de persoane vaccinate raportat la 100 și se află între Senegal și Zimbabwe.
Organizations: World Data Locations: SUA, China, vaccinați, India, America de Sud, Chile, Israel, Britanie, Bahrain, Ungaria, Serbia, Uruguay, Germania, Senegal, Zimbabwe
Израиль занимает первое место в мире по количеству вакцинированных от COVID 19 людей по отношению к численности населения. По количеству введенных доз в рейтинге лидируют США: на сегодняшний день в стране вакцинировано более 2 миллионов человек, сообщает Știri.md со ссылкой на Digi24.ro. ВВ рейтинге Our World Data сюрпризом стала Португалия, которая на данный момент находится на первом месте по количеству введенных вакцин: почти 16 500 – рекордное число, если говорить о численности населения. Следом в рейтинге находится Германия с 78 тысячами доз, однако численность населения намного больше. К настоящему времени во всем мире вакцинировано более 4,8 миллиона человек.
Persons: Știri.md Organizations: Sputnik Locations: Израиль, США, Китай, Великобритания, Португалия, Германия, Италия, Румыния, Европейский союз, Россия
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