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☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax

☆ Samsung among companies starting to draft ChatGPT policies for workers
▼ + stars: | 2023-06-13 | by ( Rachel Curry | ) www.cnbc.com time to read: +6 min

In May, Samsung banned the use of generative AI tools after the company discovered an employee uploaded sensitive code to ChatGPT. This legal mindset persists, which is one of the reasons Ironclad moved forward with generative AI policy so swiftly. Singh said, "It truly needs to be a multi-stakeholder dialogue," including teams from policy, AI, risk and compliance and legal. Creating a generative AI policy is also a good opportunity for companies to scrutinize all of their technology policies, including implementation, change management, and long-term usage. It can also include using generative AI tools as foundational content for work due to the fact it creates inherent bias.

Persons: Jakub Porzycki, Jason Boehmig, Boehmig, Navrina Singh, Singh, Vince Lynch, Lynch, it's Organizations: Samsung, Nurphoto, Getty, Companies, National AI Advisory, Intelligence, National Institute of Standards, Technology, European Union

☆ Australia’s having an intense flu season, and it could be a signal of what’s to come in the US
▼ + stars: | 2023-06-12 | by ( Jen Christensen | ) edition.cnn.com time to read: +7 min

CNN —It’s only June, but scientists in the US are already thinking about flu season. As always at this time of year, they’re keeping a close eye on Australia, which saw an early start to its flu season. “We closely monitor what happens in countries throughout the Southern Hemisphere this time of year, just to see what’s happening during their flu season. If many people opt out of the flu vaccine, cases could rise. So while Reed and her colleagues will be watching Australia’s flu numbers and running their calculations, it’s still not totally clear what 2023’s flu season will bring for the US.

Persons: CNN — It’s, don’t, Care, It’s, ”, Carrie Reed, Reed, “ We’ve, Thomas McAndrew, “, Taylor Swift, ” McAndrew, William Schaffner, Dr, Sanjay Gupta, –, it’s, ” Reed Organizations: CNN, Australian Department of Health, US Centers for Disease Control, CDC, Department of Community, Population Health, Lehigh University . “, Vanderbilt University Medical Center, National Foundation for Infectious Diseases, CNN Health, World Health Organization, agency’s Department of Health, Care Locations: Australia, Southern, Chicago, agency’s

☆ FDA advisors weigh whether Alzheimer's drug Leqembi should receive full approval
▼ + stars: | 2023-06-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

A panel of independent advisors to the Food and Drug Administration is meeting Friday to make a recommendation on whether the Alzheimer's drug Leqembi, made by Eisai and Biogen , should receive full approval. The FDA is not required to follow the advisors' recommendation, but a panel vote in favor of Leqembi would help pave the way for the treatment's approval this summer. The FDA is expected to make a final decision on Leqembi on July 6. Leqembi is the second Alzheimer's treatment from Eisai and Biogen to come under FDA review, after the controversial approval of the drug Aduhelm in the summer of 2021. Leqembi slowed cognitive decline in early Alzheimer's patients by 27% in the trial, but the treatment also carries serious risks of brain swelling and bleeding.

Persons: Eisai, Leqembi, Biogen, Aduhelm Organizations: Food and Drug Administration, FDA Locations: Leqembi, Eisai

All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness. That approval would also make Leqembi the first disease-modifying drug ever to achieve the regulatory milestone. Leqembi won accelerated approval by the FDA in January based on its ability to remove sticky amyloid plaques from the brain. Most U.S. Alzheimer's patients are Medicare-eligible. “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks."

Persons: Eisai, Leqembi, Tanya Simuni, Robert Alexander, Joanne Pike, Leroy Leo, Khushi, Julie Steenhuysen, Bill Berkrot Organizations: Food and Drug Administration, Alzheimer's Association, FDA, Northwestern University Feinberg School of Medicine, Banner Alzheimer's Institute, CAA, Medicare, Wall Street, Analysts, Alzheimer's, Thomson Locations: Leqembi, U.S, Bengaluru, Chicago

☆ Why The F.D.A. Should Move Birth Control Over the Counter - The New York Times
▼ + stars: | 2023-05-22 | by ( Eric Reinhart | ) www.nytimes.com time to read: +1 min

An advisory panel at the Food and Drug Administration this month unanimously recommended that a contraceptive pill, Opill, be made available over the counter. At a 1992 conference on birth control, an official on the F.D.A.’s fertility and maternal health drugs advisory committee, Philip Corfman, noted that the birth control pill is safer than aspirin, which is available over the counter. subsequently announced plans to convene a hearing to consider moving oral contraceptives over-the-counter. It was believed that this would greatly expand access to birth control by bypassing doctors, to whom millions of Americans then — as still now — had little access. Dr. Prescott reported that the program director of the National Women’s Health Network at the time, Cindy Pearson, said that a “birth control prescription is the poor woman’s ticket to health care.” Advocates for women’s health were concerned that if birth control were made available over the counter, then insurance might stop paying for it and impose new financial barriers to access.

☆ FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns
▼ + stars: | 2023-05-18 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration's independent panel of advisors on Thursday recommended full approval of Pfizer's vaccine that protects infants from RSV, but raised safety concerns over premature births that may be tied to the shot. Ten of the advisors said the safety data on Pfizer's shot was adequate, while four said it was not. The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's shot for infants is administered to expectant mothers in the late second or third trimester of their pregnancy.

☆ Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say
▼ + stars: | 2023-05-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The agency is expected to make a decision within weeks on Pfizer's other RSV shot for that same age group. Pfizer's RSV vaccine that protects infants is administered to expectant mothers in the late second or third trimester of their pregnancy. Some of the participants' children also had low birth weights, the staff review said. But the FDA staff said it is unlikely that those deaths are related to Pfizer's shot.

The advisers said the standoff between Republicans and Democrats in Congress and the White House has already raised taxpayer borrowing costs through weak Treasury auctions and high yields for short-dated Treasury Bills, while ratings agencies are already publishing analyses of potential U.S. ratings downgrades. They said the Treasury market's role as the backbone of the entire financial system would be called into question, leaving the debt market without a benchmark pricing firm and causing investors to pull back from fixed-income and equity markets. Their letter was distributed after President Joe Biden met with Republican House of Representatives Speaker Kevin McCarthy at the White House with no signs of softening their positions, though they agreed to continue talks. The advisers said that following the banking turmoil that started in March, the debate over raising the debt limit is "reckless and irresponsible." A protracted negotiation would have short-term costs, but a default is an "unthinkable" event, the executives said.

☆ The dollar is at 'real risk' as the political deadlock over the US debt ceiling undermines investor confidence, Goldman Sachs' Beth Hammack says
▼ + stars: | 2023-05-10 | by ( Zinya Salfiti | ) www.businessinsider.com time to read: +3 min

The political deadlock over the US debt ceiling poses a 'real risk' to the dollar, according to Goldman Sachs' Beth Hammack. "There is real risk to the US dollar as we leave this in a more protracted state of negotiations," she told Bloomberg TV. The stalemate over the borrowing limit has heightened concerns that the US could end up defaulting on its debt. "And so I think that's really confusing - I think there is real risk to the US dollar as we leave this in a more protracted state of negotiations." Lawmakers have been sparring over the debt limit, with House Speaker Kevin McCarthy recently proposing a bill that would lift the borrowing limit by $1.5 trillion while cutting spending by $4.5 trillion.

☆ A US debt default will have 'unquantifiable' adverse consequences and unthinkable long-term implications, Wall Street experts warn
▼ + stars: | 2023-05-10 | by ( Zinya Salfiti | ) www.businessinsider.com time to read: +3 min

A group of 17 top financial experts warned of "unquantifiable" consequences to come if the US defaults on its debt. In a letter addressed to Treasury Secretary Janet Yellen, they made the case for possibly repealing the debt limit altogether. The group warned that the ongoing political deadlock is particularly harmful in the midst of the banking turmoil. The Wall Street executives warned the spat is particularly harmful amid the ongoing turmoil in the banking sector. "With financial markets on edge, continuing to debate raising the debt limit is reckless and irresponsible."

☆ FDA reviewers raise doubts over data on Sarepta's gene therapy
▼ + stars: | 2023-05-10 | by ( Leroy Leo | ) www.reuters.com time to read: +2 min

May 10 (Reuters) - The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's (SRPT.O) gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency's advisers on Friday. The agency's staff on Wednesday highlighted several issues with the data and said that existing studies did not provide "unambigious evidence" that the gene therapy will benefit patients with Duchenne muscular dystrophy. The FDA also highlighted that DMD, a rare disorder that mainly affects young boys, is an urgent unmet medical need. The advisory committee's vote on Friday and an eventual decision by the FDA is seen as a test of the agency's accelerated approval pathway for gene therapies. Sarepta has three drugs available for the disease for people with different types of genetic mutations but they have to be given as weekly intravenous infusion, while the experimental gene therapy is a one-time treatment.

"The end of the COVID-19 public health emergency marks a tremendous transition for our country, for public health, and in my tenure as CDC Director," Walensky wrote to President Joe Biden in her resignation letter. "We have all benefited from her service and dedication to public health, and I wish her the best in her next chapter," Biden said in a statement. "For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations," she told CDC staff last summer. Public health experts said Walensky wrestled with political and technical challenges during her tenure. "Dr. Walensky was put into place at the CDC at a time when the agency was basically captive to politicians which clearly hampered her ability to lead," he said.

☆ Thousands of union contracts to dissolve in Mexico's fight against pro-company deals
▼ + stars: | 2023-05-03 | by ( Daina Beth Solomon | ) www.reuters.com time to read: +2 min

Mexico committed to eliminating these so-called "protection contracts" under the United States-Mexico-Canada Agreement (USMCA), a trade pact that replaced the 1994 NAFTA. "This is historic, because we finally managed to rid the labor market of pretend contracts and fake unions," Labor Minister Alcalde said in an interview. Since the vote process began four years ago, workers have cast ballots on some 20,000 contracts in sectors spanning autos, retail and mining. The Independent Mexico Labor Expert Board, a U.S. advisory committee, said in March the small number of rejected contracts "raises serious doubts about the credibility" of the process. Alcalde said she expects unions to aim to establish new contracts in place of ones that were canceled.

☆ FDA approves GSK's RSV vaccine for older adults, world's first shot against virus
▼ + stars: | 2023-05-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. London-based GSK during an earnings presentation last week said it has "millions" of doses of the RSV vaccine ready to ship. In March, an independent panel of advisors to the FDA recommended GSK's RSV vaccine based on data from a phase three trial on older adults. A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDA briefing document. The FDA flagged the disorder as a potential safety issue with Pfizer's RSV vaccine for older adults.

☆ Exclusive: US regulators worried about uninsured deposits before March crisis
▼ + stars: | 2023-04-27 | by ( Douglas Gillison | ) www.reuters.com time to read: +3 min

Officials had yet to do the same for regional banks, some of which had grown to considerable size and complexity, said Gruenberg. One member, Timothy Mayopoulos, who within months would quickly be named chief executive of Silicon Valley Bank after it failed in March, queried regulators about dealing with regional banks' high proportion of uninsured deposits. Banking regulators have come under criticism since March for failing to stave off the crisis triggered by a run on Silicon Valley Bank, most of whose deposit base was uninsured. The Fed and FDIC are expected to release reports on Friday on their supervision of Silicon Valley and Signature Bank. The meeting was the first since the creation of the panel more than a decade ago to consider policy responses to failures in the middle-tier of large financial institutions.

☆ Fact Check-COVID ‘monovalent’ vaccines not banned, FDA approval not withdrawn
▼ + stars: | 2023-04-25 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

But the original vaccines remain licensed in the United States and are not “banned” as suggested by some social media users. An FDA spokesperson also commented on the agency’s official Twitter account: “It's probably worth clarifying that the monovalent vaccines are still approved (licensed). EUA information for the Moderna and Pfizer vaccines can be seen on the FDA website (here) , (here). The FDA withdrew authorizations for emergency use of Pfizer-BioNTech and Moderna monovalent COVID vaccines while authorizing use of the updated, bivalent versions in all age groups. The agency did not withdraw its approval or license of the original vaccines, nor “ban” their use.

☆ China has an inflation problem. It’s way too low
▼ + stars: | 2023-04-24 | by ( Laura He | ) edition.cnn.com time to read: +6 min

That’s raising the specter of a tailspin of falling prices and wages from which the economy may struggle to recover. “Our core view is that China’s economy is deflationary,” wrote Raymond Yeung, chief economist for Greater China at ANZ Research, last week, soon after China released its first-quarter GDP growth figures. Instead of spending money, people are hoarding cash at a record rate. “Even with a conservative estimate, 500 billion yuan in consumption vouchers will drive one trillion yuan in overall consumption, ” Li said in a video posted on his Weibo social media account on Tuesday. In return, the government could receive at least 300 billion yuan through taxes generated by the increase in spending, he said“So it only takes 200 billion yuan in spending for the central government to drive one trillion yuan in consumption,” he said.

☆ India court acquits 69 Hindus of murder of 11 Muslims during 2002 riots
▼ + stars: | 2023-04-20 | by ( ) edition.cnn.com time to read: +2 min

An Indian court on Thursday acquitted 69 Hindus, including a former minister from the ruling Bharatiya Janata Party (BJP), of the murder of 11 Muslims during communal riots in the western state of Gujarat in 2002. A total of 86 Hindus were accused of the killings in the Naroda Gam district of Ahmedabad, 17 of whom died during trial. We will study the grounds on which the court has acquitted the accused persons,” Pathan said. Kodnani was also an accused in a case in which 97 people were killed in the 2002 riots. At least 1,000 people, mostly Muslims, were killed across Gujarat in the 2002 riots.

☆ Fact Check-Kansas trans sports bill does not authorize ‘genital inspections of children’
▼ + stars: | 2023-04-19 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

Reuters reported on March 9 (here) that the Kansas Republican legislature passed a bill banning transgender athletes from competing in female school sports if they were born male. The bill banned transgender girls and women from female sports teams in public elementary schools, middle schools, high schools, and colleges, and from private school teams that compete against public schools. Bill HB 2238 (here) restricts “participation on women’s teams to female students” and provides a basis for legal action if the act is violated. Nothing in the bill specifies how the biological sex of the students is to be determined. The Kansas bill HB 2238 does not contain any reference to genital inspections of student athletes, nor does it specify how state education groups should implement the new law restricting participation in girls’ sports teams.

☆ US CDC signs off on second Omicron-updated COVID booster for older adults
▼ + stars: | 2023-04-19 | by ( ) www.reuters.com time to read: +1 min

April 19 (Reuters) - Older people and those with weakened immune systems may get a second dose of Omicron-targeting COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday. The agency's decision after its advisory committee's meeting aligns it with the U.S. Food and Drug Administration's authorization on Tuesday for a second dose of Omicron-updated booster for the specified high-risk population. Adults aged 65 years and older can take a second dose of the updated vaccine, the CDC said, while people who are immunocompromised can get additional doses. It also said the original COVID-19 vaccine will no longer be recommended for use in the United States. Monovalent COVID-19 vaccines from Novavax (NVAX.O) or Johnson & Johnson's (JNJ.N) Janssen were not affected by the changes made today, the agency said.

"China was initially in discussions to be part of the project," the official said, declining to be named as the information was deemed sensitive. China has since banned the sale and consumption for food of wildlife animals. China's public security organs have handled more than 70,000 criminal cases involving wild animals from 2020-2022, confiscating 1.37 million wild animals in the process, state news agency Xinhua has reported. SLOW STARTThe SAFE project surveys only began in October last year, when the project's assessors visited Khao Kheow zoo and a cafe in Thailand. The wet markets targeted are markets where wild animals are sold alongside fresh meat and vegetables.

☆ Health plans could soon reduce coverage for preventive care. Here's what to know
▼ + stars: | 2023-04-13 | by ( Annie Nova | ) www.cnbc.com time to read: +2 min

Around 100 million people with private insurance got preventive care required under the ACA in 2018, one estimate found, making it the provision with the widest reach. Insurers generally must not impose copays or deductibles on the recommended preventive care. "Many preventive care services are not covered by this decision," Simon said. Health plans will still be required to ensure no copays for many preventive services, including birth control and mammograms, Simon said. Some states have their own mandates, meanwhile, around free preventive care.

☆ A flurry of news outside the portfolio has implications for 3 of our stocks
▼ + stars: | 2023-04-13 | by ( Jeff Marks | ) www.cnbc.com time to read: +7 min

Here are three noteworthy news developments over the past two days, which contain useful insights about our stocks. For the full year 2023, Novo now expects sales growth in the range of 24% and 30%, compared to prior estimates of 13% to 19%. In addition, operating profit growth is expected to be in the range of 28% and 34%, up from a prior range of 13% to 19%. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.

☆ Study finds 45 negative health effects of added sugar
▼ + stars: | 2023-04-05 | by ( Kristen Rogers | ) edition.cnn.com time to read: +7 min

CNN —There are at least 45 good reasons to cut back on added sugar, according to a new study. Copious research has shown the negative effects of excessive sugar intake on health, which has informed recommendations to limit consumption of “free” or added sugar to less than 10% of a person’s daily caloric intake. “This means that whole, intact grains don’t cause the same spikes in blood sugar that we experience when we eat simple sugars. A doughnut has around 15 to 30 grams of sugar, according to the Cleveland Clinic. Cooking and baking at home more often is one of the best ways to reduce sugar intake, Aggarwal said.

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