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A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. The Maryland-based company, whose COVID vaccine is its lone marketed product, has adopted cost-cutting measures and is counting on commercial sales of its updated shot to help it stay afloat. The CDC's Advisory Committee on Immunization Practices (ACIP) will not meet again to discuss the Novavax shot, a spokesperson said. Novavax's original COVID shot received U.S. authorization in July 2022, long after Pfizer and Moderna vaccines were in use. All three of the updated shots target the XBB.1.5 variant of the coronavirus.
Persons: Dado Ruvic, BioNTech, COVID, John Jacobs, Jacobs, Sriparna Roy, Bill Berkrot Organizations: REUTERS, U.S . Food, Drug Administration, U.S . Centers for Disease Control, Prevention, Pfizer Inc, Moderna, FDA, Pfizer, Moderna's, Thomson Locations: U.S, Maryland, Bengaluru
The proposals comes from NIL working group recommendations and don't become final until the council meeting concludes Wednesday. The proposals could be adopted as soon as January at the NCAA convention. Inconsistencies and a lack of transparency has made it almost impossible for the NCAA to enforce rules prohibiting NIL being used as an improper recruiting inducement or pay for play. College sports leaders have been lobbying lawmakers in Washington for federal NIL legislation, but with help uncertain to come, the NCAA is working on creating its own rules. The proposals include expanding suspensions for coaches to include the days between competitions, having schools incur penalties for employing individuals who have received a show-cause order and expanding disassociations with boosters who violate rules.
Persons: , Charlie Baker, , Morgyn Wynne Organizations: INDIANAPOLIS, NCAA Division, NCAA, DI, Association, College, Oklahoma State, Division, AP Locations: Washington
Political Cartoons View All 1190 ImagesFor years, California didn't regulate groundwater, allowing farmers and residents alike to drill wells and take what they needed. There is a small market, hardware store, a Western-themed boutique hotel and miles of land sown with olives, pistachios, grapes and carrots. From the start, Grimmway and Bolthouse participated in the formation of the local groundwater sustainability agency and plan. Furstenfeld, who sits on an advisory committee to the groundwater agency, doesn’t own land and doesn’t have an attorney. The company that owns the land, Bolthouse Land Co., is still litigating.
Persons: Lee Harrington, “ It’s, ” Harrington, Bolthouse, , Dan Clifford, Jeff Huckaby, , ” Huckaby, Jake Furstenfeld, David, Goliath, Alfonso Gamino, haven’t, Eric Garner, Huckaby, Grimmway, Jean Gaillard, ” Gaillard Organizations: , Bolthouse Locations: Calif, California, New, Los Angeles, Cuyama, Oxnard, Pleasant, San Diego County, Southern California
SYDNEY, Sept 29 (Reuters) - The blocking of three major deals by Australia's antitrust regulator in the past year was a coincidence, its chair told Reuters, pushing back against concerns among bankers that it has become deal-averse. "There happens to have been a sequence, frankly coincidentally as it turns out, of oppositions," ACCC Chair Gina Cass-Gottlieb said in an interview. There are some concerns that it could be blocked as Brookfield owns AusNet, a poles and wires asset in Victoria state. Cass-Gottlieb also said she doubted foreign investors have been dissuaded from pursuing deals in Australia which does not require companies to get formal clearance before proceeding with a takeover. "The recent stream of merger blockages will make foreign investors think twice."
Persons: Gina Cass, Gottlieb, Canada's Brookfield, Cass, Stephen Corones, Hannah Marshall, it's, Byron Kaye, Scott Murdoch, Edwina Gibbs Organizations: Australian Competition, Consumer Commission, Telstra, TPG, ANZ, Transurban, Origin Energy, Brookfield, FOCUS Cass, Investors, Queensland University of Technology, Cass, Marque Lawyers, Thomson Locations: Melbourne, AusNet, Victoria, Australia, Queensland
CNN —When the World Health Organization recommended on Friday which influenza viruses to target in vaccines for next year, it removed a family of viruses that hasn’t been seen since the early days of the Covid-19 pandemic. Although flu has rebounded, the family of viruses known as influenza B/Yamagata did not, suggesting it may have been driven to extinction. Quadrivalent vaccines, which target four types of flu, can still target a B/Yamagata lineage component. WHO advisers emphasized that flu vaccines are safe and effective, no matter which formulation a country uses. The FDA’s vaccine advisory committee is scheduled to meet October 5 to discuss recommendations for flu vaccines to be offered in the Southern Hemisphere in 2024.
Persons: Yamagata, That’s, ” David Wentworth, , Kanta Subbarao, Peter Doherty, Dr, Sanjay Gupta, Wentworth, it’s Organizations: CNN, World Health Organization, Southern, WHO, Surveillance, US Centers for Disease Control, Northern, Reference, Research, Influenza, Peter, Peter Doherty Institute for, Get CNN, CNN Health, Food and Drug Administration, Southern Hemisphere Locations: Victoria, Yamagata, Australia, United States
That Pfizer (PFE.N) shot and one developed by GSK (GSK.L) in May became the first two RSV vaccines to win U.S. approval, for use in people aged 60 and over to prevent severe illness. Still, infants and older adults have a higher risk of developing severe RSV. RSV leads to 58,000 to 80,000 hospitalizations among children under age 5, and 60,000 to 160,000 hospitalizations among adults age 65 and older each year, according to the CDC. Early data suggests that the RSV shots are protective for at least two years, but it is not yet clear how often older adults will need to be revaccinated. Can I get the RSV shot alongside my COVID and flu shots?
Persons: Pfizer's, Synagis, it's, Jeffrey Duchin, you've, Michael Erman, Bhanvi, Caroline Humer, Bill Berkrot Organizations: . Centers for Disease Control, Prevention, Pfizer, GSK, CDC, FDA, Sanofi, AstraZeneca, Infectious Diseases Society of America, CVS, Humana, Thomson Locations: U.S, Aetna, New York, Bengaluru Edtiting
An artificial womb for humans would be a scientific advance that could help solve a major health problem. An artificial womb is not designed to replace a pregnant person; it could not be used from conception until birth. The artificial womb could be able to help the baby develop further through those vital final stages when the lung and brain are developing. In each study, the artificial womb is constructed a little bit differently. If an artificial womb was ultimately approved for use with humans, doctors will have to have conversations with parents about how successful such an intervention could be.
Persons: Prematurity, there’s, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, World Health, US Centers for Disease Control, Pediatric, Children’s Hospital of Philadelphia, Newborn, University of Michigan, University of Toronto, CNN Health, FDA Locations: White, Japan, Australia
SAN FRANCISCO (AP) — Reparations advocates urged San Francisco supervisors Tuesday to adopt recommendations aimed at shrinking the racial wealth gap and otherwise improving the lives of Black residents as atonement for decades of discriminatory city policies, including the granting of a lump-sum $5 million payment to every eligible adult. San Francisco's Board of Supervisors was expected to vote Tuesday to accept the final reparations plan issued by the city's African American Reparations Advisory Committee. San Francisco embraces its image as a sanctuary for people living in the country illegally and members of the LGBTQ community. More than 200 people rallied outside City Hall before Tuesday’s board meeting, demanding that the city start addressing the enormous disparities for Black San Franciscans. Critics say the city's reparations plans are unconstitutional and would ruin the city financially.
Persons: Mayor London Breed, Rev, Amos C, Brown, Richie Greenberg, ” California's, Eric Risberg Organizations: FRANCISCO, San, Francisco's, Supervisors, Mayor London, Black San, Associated Press Locations: San Francisco, Francisco
When the center was being built, Mr. O’Farrill was part of an advisory committee of artists; he urged the center to pay close attention to acoustics. He’s a very thoughtful man, and he’s looking to expand the conversation on what performing arts is, what elitism does to the arts. Maybe you make it by bringing music that’s just so incredible that everybody wants to get on the subway and go down there. For a performing arts center to support that speaks straight to my heart. And we have the place called the Perelman Center right next to ground zero that is open to the whole world.
Persons: Arturo O’Farrill, O’Farrill, , ” Mr, “ That’s, He’s, ” Laurie Anderson, , , it’s, that’s, Ms, Kidjo, I’ve Organizations: , Refuge, Jazz Alliance, clarion, Perelman Center Locations: New York City, Americas, Europe, Paris, Benin, Brooklyn
"That was a major motivating factor behind seeing if I could bring something new to the issue of concussions." The five millimetre thick G8RSkin balaclava is intended to stabilize the neck and head and dissipate the energy from a hit. Testing at Virginia Tech's Helmet Lab found it could reduce the risk of concussions by almost 60%. Miami Dolphins quarterback Tua Tagovailoa considered retiring from football over the concussions he suffered in the 2022, the distressing scenes of which rocked the NFL. "It's very exciting," said committee member Dr. Charles Popkin, a team physician for USA Hockey and member of the USA Hockey National Safety and Protective Equipment Committee.
Persons: Carter, F.J, Hogg, I've, Tua Tagovailoa, G8RSkin, Jay Brunetti, Charles Popkin, Lori Ewing, Christian Radnedge Organizations: Lee University, Johns Hopkins University, Miami Dolphins, San Francisco 49ers, USA Hockey, USA Hockey National Safety, Protective, Committee, Thomson Locations: Dallas, Washington, balaclava, Virginia, Baltimore
It is safe to use, but an independent advisory committee to the FDA agreed Tuesday that it is ineffective in pill form. But before then, there are things you can do at home to help relieve your symptoms, he said. Warm compresses, hot showers and hydrationNoses like to be hydrated and warm, Brodner said. But steam from a hot shower or a warm compress placed over your nose can also heat things up nicely. That runny nose will help drain mucus from your sinuses — and hopefully flush out whatever is irritating it, Brodner said.
Persons: , David C, “ You’ll, ” Phenylephrine, Brodner, guaifenesin, Richard J, Harvey, Shanna Miko, you’re, ” Brodner, Stephen Rennard, Larson, Rennard, Organizations: CNN, Food and Drug Administration, FDA, Macquarie University, Epidemic Intelligence, US Centers for Disease Control, CDC, Medicine, University of Nebraska Medical Center Locations: Boynton Beach , Florida, Omaha
Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA Advisory Committee: Ingredient in common decongestant ineffectiveDr. Scott Gottlieb joins 'Power Lunch' to discuss cold medicine being found to be ineffective in decongestant and the latest push from the government for Americans to get vaccinated against Covid-19.
Persons: Scott Gottlieb Organizations: FDA, Covid Locations: decongestant
The main ingredient used in many popular over-the-counter cold and allergy medications doesn't actually work to get rid of nasal congestion, an advisory panel to the Food and Drug Administration declared Tuesday. The FDA typically follows the advice of its advisory committees but it is not required to do so. Pulling phenylephrine from the market could also affect retail pharmacy chains, which rake in revenue from selling over-the-counter cold and allergy pills. Retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, up 30% from 2021, according to data compiled by FDA staff. Yet FDA staff, in briefing documents posted ahead of the meeting this week, concluded that oral formulations of phenylephrine don't work at standard or even higher doses.
Persons: Johnson, Scott Melville Organizations: Food and Drug Administration, FDA, Procter, Gamble, Consumer Healthcare Products Association, CVS, Walgreens, University of Florida Locations: U.S
Pseudoephedrine, which is found in behind-the-counter products like Sudafed, is effective at clearing congestion, Dr. Dykewicz said; just keep in mind that it can come with side effects. After that, you run the risk of rebound congestion: when the mucosal surfaces in your nose swell, making you feel even more clogged up than before. There are some sprays that you can use for longer stretches, without the rebound risk, namely steroid sprays that contain ingredients like fluticasone (Flonase) or triamcinolone (Nasacort), which are available over-the-counter. Can I treat congestion without medication? In many cases, you can treat a stuffed-up nose by standing in a steamy shower or using a humidifier to help clear your nasal passages, Dr.
Persons: , Jennifer Le, Dykewicz, Allegra, Mark Aronica, Le, Andrew Lane, Johns Organizations: Skaggs School of Pharmacy, Pharmaceutical Sciences, University of California, Cleveland Clinic, Sinus Locations: San Diego
Goldman Sachs thinks late-stage biotech company Geron was due for a correction and now has the potential to surge higher. Analyst Corinne Jenkins upgraded Geron to buy from neutral. The analyst highlighted U.S. Food and Drug Administration acceptance of Geron's new drug application for imetelstat, a treatment for individuals with transfusion-dependent anemia in lower-risk myelodysplastic syndromes, or MDS. Shares of Geron have taken a hit this year with a 27% drop this quarter and 3.3% in year-to-date losses. "Despite the AdCom, the physicians we spoke with see a very high likelihood of imetelstat approval based on the publicly available data," the analyst said.
Persons: Goldman Sachs, Corinne Jenkins, Geron, KOLs, Jenkins, Michael Bloom Organizations: Geron, Food, Drug, FDA Locations: U.S
Updated Covid vaccinesOn Monday, the Food and Drug Administration approved the new Covid vaccine, which will target a variant of Omicron called XBB.1.5. When should you get your updated Covid vaccine? Older adults, and people with heart and lung disease, should also consider getting the RSV vaccine, says Pavia. "Because the ACIP gave a softer recommendation to the RSV vaccine, coverage is going to be variable," says Pavia. For those with certain Medicare plans, the RSV vaccine should be covered, specifically under a Part D plan.
Persons: there's, Andrew Pavia, It's, Don't, Biden, you've, they're, hasn't, it's Organizations: CNBC, Centers for Disease Control, University of Utah, Children's Hospital, CDC, Food and Drug Administration, COVID, FDA, CDC's, U.S . Department of Health, Human Services, Infants, The New York Times Locations: Pavia
Washington CNN —America’s small businesses felt gloomier in August as they continued to struggle with inflation and hiring qualified workers, according to a survey from the National Federation of Independent Business released Tuesday. Optimism among more than 600 small businesses surveyed declined in August from the prior month, snapping a three-month streak of improving sentiment. The share of small business owners saying they had job openings that were hard to fill stood at 40% last month, down slightly from July but still historically high. “With small business owners’ views about future sales growth and business conditions discouraging, owners want to hire and make money now from strong consumer spending,” said Bill Dunkelberg, the NFIB’s chief economist, in the release. The US economy remains on strong footing, despite rapid rate hikes, with consumer spending jumping 0.8% in July and retail sales advancing 0.7% that month.
Persons: Washington CNN —, , Bill Dunkelberg, Goldman Sachs, Simona Mocuta Organizations: Washington CNN, National Federation of Independent Business, Federal Reserve, Labor Department, American Bankers, Economic, Committee, State Street Global Advisors
Airbnb is adding James Manyika, Google's "AI ambassador," to its board of directors, the company said Monday. Manyika's addition underscores CEO Brian Chesky's ambitions in artificial intelligence, which Chesky has said will radically change the Airbnb platform by 2024. As Google's head of Research, Technology and Society, Manyika reports to CEO Sundar Pichai and focuses on how tech affects user's daily lives. Increasingly, that encompasses the company's AI research and products. With Manyika on the board, Chesky gains a powerful voice that sits at the intersection of AI and society.
Persons: James Manyika, Brian Chesky's, Chesky, Sundar Pichai, Belinda Johnson Organizations: Research, Technology, Society, National AI Advisory, McKinsey & Company
FDA Approval of New COVID Boosters Could Come by Friday
  + stars: | 2023-09-07 | by ( Sept. | At A.M. | ) www.usnews.com   time to read: +2 min
Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. This time, the FDA may grant full approval for the boosters rather than emergency use authorization, according to NBC News sources. If the FDA doesn’t approve the boosters on Friday, it could do so early next week. While protection wanes over time, about 97% of adults have some level of protective immunity from past COVID infections and vaccinations. The Biden administration has announced a “bridge” program to offer uninsured people access to free boosters through 2024.
Persons: Cara Murez HealthDay, Mandy Cohen, Jennifer Kates, Biden, Kates Organizations: U.S . Food, Drug Administration, NBC News, U.S . Centers for Disease Control, Prevention, Pfizer, Moderna, NBC, Global Health, HIV
The decision by EPA Administrator Michael Regan means that one of the agency's most important air quality regulations will not be updated until well after the 2024 presidential election. Political Cartoons View All 1145 ImagesThe delay marks the second time in 12 years that a Democratic administration has put off a new ozone standard prior to an election year. Former President Barack Obama shut down plans to tighten ozone standards in 2011, leading to four-year delay before the standards were updated in 2015. "Unfortunately we’ve seen the process for updating the ozone standards repeatedly swept up in political games that risk lives,'' the lawmakers said in an Aug. 7 letter to EPA. Lianne Sheppard, a University of Washington biostatistics professor who chairs the scientific advisory panel, said Regan's decision was “his alone” to make.
Persons: Michael Regan, , Regan, , Barack Obama, Paul Billings, Raul Garcia, ” Garcia, Sen, Sheldon Whitehouse, we’ve, Conor Bernstein, EPA’s, Donald Trump, Bernstein, Andrea Woods, , Lianne Sheppard, Richard Moore, Peggy Shepard, Moore, Sheppard, Tomas Carbonell, Carbonell Organizations: WASHINGTON, Environmental Protection Agency, Republicans, Democratic, American Lung Association, National Mining Association, American Petroleum Institute, Scientific Advisory, White, Environmental, EPA, University of Washington, E, White House, Los Jardines Institute, WE ACT, Environmental Justice, Air Locations: Billings, Albuquerque , New Mexico, New York City
CNN —Covid-19 vaccines that have been tweaked to teach the body how to fend off the current crop of circulating variants are now expected to land in drugstores and clinics in mid-September, senior administration officials say. The US Food and Drug Administration is expected to give its nod to the updated vaccines in a few weeks. Officials said ACIP will meet quickly after the FDA decision in order to expedite the regulatory steps and get the vaccines to market. The advisory group is scheduled to meet to discuss Covid-19 vaccines on September 12, meaning the vaccines could become available soon after. The details of the pharmacy program are still being worked out, and there may be a slight lag in getting free vaccines at some stores.
Persons: CNN —, ACIP, Mandy Cohen, , Dr, Sanjay Gupta, Cohen, There’s Organizations: CNN, US Food and Drug Administration, US Centers for Disease Control, Officials, CDC, Covid, Pfizer, Moderna, FDA, EG, Affordable, CVS, Walgreens, Walmart, CNN Health Locations: drugstores, Covid
Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies. An FDA panel of outside experts backed the safety and effectiveness of Pfizer's RSV vaccine for women in their second and third trimesters earlier in May. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. Infants are at greatest risk for severe illness from RSV. An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data.
Persons: Pfizer, Mariam Sunny, Bhanvi, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S . Food, Drug Administration, FDA, Pfizer, U.S . Centers for Disease Control, Sanofi, AstraZeneca, GSK, Thomson Locations: U.S, United States, Bengaluru, New York
Trump had asked for Merchan to step off the case in Manhattan Supreme Court, where his trial is set to begin in late March, citing three different areas of potential conflicts of interest. The judge wrote that he "finds that recusal would not be in the public interest." Judge Juan Merchan said he had "carefully weighed" the legal standards for recusing himself after Trump cited the judge's purported conflicts of interest. The New York judge set to preside over the porn star hush money trial of Donald Trump refused on Monday to step off the case, saying he is certain he can be "fair and impartial" to the former president . Merchan cited a 1988 New York federal appeals court decision related to judicial recusal.
Persons: Donald Trump, Juan Merchan, Stormy Daniels, Trump, Merchan, recusal, recusing, Trump's, Michael Cohen, Daniels, Cohen, Allen Weisselberg, Joe Biden, Re Drexel Burnham Lambert Organizations: New, Republican, Trump, Trump Organization, Democratic, New York, Re, Manhattan, Attorney's Office Locations: Manhattan, New York City, New York
Some public health experts hope that Americans will welcome the new shot as they would a flu jab. In the fall of 2022, by which time most people had either had the COVID virus or the vaccine, fewer than 50 million people got the shots. Its biggest rival, Moderna, conceded demand could be as few as 50 million shots. POST PANDEMIC VACCINEThe COVID public health emergency ended in May and the government has handed much of the duty of vaccinating America to the private sector. As with the flu, Pfizer (PFE.N)/BioNTech SE (22UAy.DE), Moderna (MRNA.O) and Novavax (NVAX.O), have created versions of the COVID vaccine to try to match the variant they believe will be circulating this fall.
Persons: Dado Ruvic, Ashley Kirzinger, Kirzinger, BioNTech, Jefferies, Michael Yee, " Yee, Mandy Cohen, William Schaffner, Schaffner, David Boulware, Michael Erman, Caroline Humer, Diane Craft Organizations: REUTERS, CVS Health, Family, Reuters, Pfizer –, Moderna, Pfizer, U.S . Centers for Disease Control, Prevention, CDC, U.S . Food, Drug Administration, EG, Vanderbilt University, University of Minnesota, Thomson Locations: U.S, America, United States, COVID, CDC's
Singapore Exchange revises IPO rules for life science firms
  + stars: | 2023-08-10 | by ( ) www.reuters.com   time to read: +1 min
A man wearing a protective face mask walks past the Singapore Exchange (SGX) which stays open during "circuit breaker" measures to curb coronavirus COVID-19) in central business district area in Singapore, April 7, 2020. REUTERS/Edgar Su/File PhotoSINGAPORE, Aug 10 (Reuters) - Singapore Exchange Ltd (SGX) (SGXL.SI) is amending its initial public offering (IPO) rules to clarify that life science companies seeking to list on its mainboard exchange do not need to be revenue-generating. The revision was based on a publication of a Listings Advisory Committee's decision on SGX's life sciences listing framework on Thursday. SGX introduced the life science listing framework in 2009, where it waived certain IPO requirements including profitability and revenue for life science companies. The rules under the life science listing framework were not adjusted to reflect 2012 amendments made to the mainboard listing criteria.
Persons: Edgar Su, SGX, Yantoultra, Jason Neely Organizations: Singapore Exchange, REUTERS, Singapore Exchange Ltd, Thomson Locations: Singapore, SINGAPORE
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