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☆ Not enough data to support multiple annual COVID boosters, U.S. CDC advisers say
▼ + stars: | 2023-02-24 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia September 30, 2014. The CDC advisers did not vote on new recommendations for how the COVID-19 shots should be administered on Friday. But ACIP advised showing flexibility in recommendations for those with compromised or weakened immune systems to allow more frequent doses for those most vulnerable to severe COVID. About 53.3 million people in the United States - around 16% of the U.S. population - have received a COVID-19 booster shot since updated versions of the vaccines were authorized in September. That compares with 230 million people, around 70% of the population, that received an initial two-dose series of the COVID vaccines.

☆ Flu vaccine was 68% effective at preventing hospitalization in children but less protective for seniors this season
▼ + stars: | 2023-02-22 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Paquita Bonillo, 84 years old, receives the fourth dose of Covid-19 and flu vaccine in the garden of the Feixa Llarga nursing home on September 26, 2022 in Barcelona, Spain. The flu vaccine has been 68% effective at preventing hospitalizations in children but has been less protective for seniors this season, according to preliminary data released Wednesday by the Centers for Disease Control and Prevention. The vaccine was 35% effective at preventing hospitalization for seniors in one study, and 42% effective in a second analysis. The flu hit early this season, as the weekly hospitalization rate peaked in December and has declined since then, according to CDC data. More than 100 children have died from the flu this season.

☆ Trump and Kushner's Saudi Ties Are an Ethical Minefield: Watchdog
▼ + stars: | 2023-02-15 | by ( Charles R. Davis | ) www.businessinsider.com time to read: +12 min

Weeks after leaving office, Jared Kushner obtained a $2 billion investment from the Saudi government. The Saudi support came despite the kingdom's own financial advisers urging against any investment in Kushner's new company, citing the "inexperience" of its top brass. Let's start with Jared Kushner before we get into the LIV Golf situation. You have John Bolton, Trump's own national security advisor, making it very clear that you had somebody, like Jared — and President Trump, apparently — working to promote their business interests. Trump, not only did he keep his company, the Trump Organization, but he's a transactional president, right?

☆ FDA advisors recommend over-the-counter use of life-saving opioid overdose treatment Narcan
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Narcan nasal spray quickly reverses an overdose from heroin and prescription painkillers. The Food and Drug Administration's independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment. Emergent BioSolutions ' Narcan is the most commonly sold treatment for opioid overdoses. Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.

☆ Trump wants back in the casino biz — as Bally's landlord in the Bronx. Many approvals would still be needed.
▼ + stars: | 2023-02-14 | by ( Laura Italiano | ) www.businessinsider.com time to read: +4 min

Under a deal struck in December, Trump would sub-lease 17 acres of his Bronx golf course to Bally's. Bally's bid for a new casino on the city-owned grounds of Trump Golf Links at Ferry Point was first reported on Sunday by the New York Post. Proposals must be approved by a local community advisory committee that includes the governor, the mayor, the local state senator and assembly member, the borough president, and the local city council member. "We are incredibly excited at the prospect of bringing Bally's community-centered approach to gaming and entertainment to the Bronx," a casino spokesperson told Insider. One of those leaders is local city council member Marjorie Velazquez, who applauded the prospect of bringing jobs to her neighborhood.

☆ U.S. FDA approves GSK's anemia drug
▼ + stars: | 2023-02-01 | by ( ) www.reuters.com time to read: +1 min

Feb 1 (Reuters) - The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc's (GSK.L) drug to treat anemia in some patients with chronic kidney disease. The FDA approved Jesduvroq tablets as the first oral treatment for anemia caused by chronic kidney disease for adults who have been on dialysis for at least four months. The treatment is not approved for patients who are not on dialysis because its safety has not been established in that population, the FDA said. The health agency's decision comes after its advisory committee recommended the treatment for some kidney patients in October. The approval for the anemia drug also makes it GSK's first since it spun off its consumer health business, home to Sensodyne toothpaste and Advil pain killers, last year.

An advisory committee to the Food and Drug Administration on Thursday raised doubts about shifting toward a yearly Covid booster for most adults and children, saying too many questions about the virus still remain unanswered. The FDA convened its Vaccine and Related Biology Products Advisory Committee to discuss how the Covid vaccines may change moving forward. On Monday, the agency published briefing documents proposing annual Covid shots that target the latest variants of the virus — an approach similar to the yearly flu shot. Some committee members said they would prefer to make multiple yearly meetings on the Covid vaccines the norm. In a unanimous vote, the committee recommended using the bivalent formula in all Covid vaccines moving forward, not just for booster shots.

☆ FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses
▼ + stars: | 2023-01-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration's independent advisory committee on Thursday unanimously recommended replacing Pfizer and Moderna's original Covid vaccine used in the U.S. for everyone's first two immunizations with the new bivalent omicron shots. Instead, the drugmakers' bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series. Currently, Pfizer's and Moderna's omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain. The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter.

☆ Updated Covid boosters cut the infection risk from XBB.1.5 subvariant by half, CDC finds
▼ + stars: | 2023-01-25 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +4 min

The updated Covid boosters reduce the risk of Covid infection from the predominant omicron subvariant by nearly half, according to early data published Wednesday by the Centers for Disease Control and Prevention. The findings are “quite reassuring,” Dr. Brendan Jackson, the head of the CDC’s Covid response, said on a call with reporters Wednesday. As of last Wednesday, only about 15% of people in the U.S. had received an updated booster, according to CDC data. People who were vaccinated but had not received the updated booster were compared to those who got the updated booster in the previous two to three months. People who got the updated boosters are probably "much more likely to wear masks indoors or restrain their travel or not go to indoor restaurants," he said.

☆ FDA proposes simplifying the Covid vaccine schedule, making it similar to the flu shot
▼ + stars: | 2023-01-23 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com time to read: +3 min

Food and Drug Administration advisers will meet Thursday to discuss simplifying the Covid vaccination schedule, allowing most people to get the currently available booster, regardless of how many doses they had received before that. The FDA is proposing skipping over that primary series, meaning that most unvaccinated individuals could go ahead and get the latest booster shot if they decided to get a Covid vaccine. The FDA’s proposal, experts say, would greatly simplify the Covid vaccination schedule in the United States — aligning it more closely with the annual flu shot. In another similarity to the flu shot, the FDA is considering whether the Covid vaccine should be updated at least once a year, based on what strains are in circulation. Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said simplifying the Covid vaccine schedule makes sense.

☆ Brazilian lender Santander's Chairman Rial resigns
▼ + stars: | 2023-01-20 | by ( ) www.reuters.com time to read: +1 min

SAO PAULO, Jan 20 (Reuters) - Brazilian lender Santander Brasil SA said on Friday its chairman and former chief executive, Sergio Rial, is resigning from his position at the firm. The resignation comes just days after Rial quit his short-lived job as chief executive of retailer Americanas SA after finding accounting "inconsistencies" that led the company to file for bankruptcy protection. Rial was Santander Brasil's CEO for six years, as well as the bank's regional head for South America, before transitioning to board chairman in early 2022. He is also chairman of the board at fuel distributor Vibra Energia SA (VBBR3.SA), vice chair at BRF SA (BRFS3.SA) and a board member at Delta Air Lines (DAL.N). Rial will be replaced on an interim basis by his vice chair, Deborah Stern Vieitas, until the bank's next general meeting on April 28.

☆ The biggest security pros and cons of using Bluetooth GPS trackers
▼ + stars: | 2023-01-14 | by ( Kaitlin Balasaygun | ) www.cnbc.com time to read: +10 min

Bluetooth tagging devices are catching on, and keeping an eye out on the world in ways never before possible. For pet owners, these GPS devices can be used as a cheaper alternative to microchipping your dog. Here are some basics to know about Bluetooth tags if you're using one already, or considering adding one to your tech-enabled life. "The problem with Bluetooth trackers … is there's no way to prevent a victim from being stalked by one of these devices because they don't control it. Two women recently filed a class-action lawsuit against Apple alleging lack of protections the AirTag has against stalking.

☆ Nebraska Gov. Pillen appoints former Gov. Pete Ricketts as Ben Sasse's Senate replacement
▼ + stars: | 2023-01-12 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Summer-Concepcion-Byline-Jm.Jpg | Summer Concepcion | ) www.nbcnews.com time to read: +5 min

Ricketts, a Republican like Pillen and Sasse, will serve two years ahead of a 2024 special Senate election. Sasse, a vocal critic of former President Donald Trump and his supporters, officially resigned from the Senate on Sunday. Pillen said Ricketts was tapped for Sasse’s seat after more than 100 people applied and nine were interviewed. Following Pillen’s remarks, Ricketts thanked the governor, saying he was proud to support his campaign, and also thanked Sasse for his service. A top political ally of Pillen, Ricketts endorsed Pillen to succeed him and was a favorite to replace Sasse.

A key adviser to the Food and Drug Administration's vaccine panel is questioning whether more Covid booster shots are necessary for healthy, younger people. The FDA later backed the vaccine panel, authorizing a new formulation of the booster shots. “The people who are talking about why young people need it are missing the point,” he said, referring to the booster. Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, continues to encourage Covid boosters for everyone who is eligible. Relatively few people in the U.S. have had updated boosters.

☆ Janet Yellen is staying put to oversee billions in climate spending
▼ + stars: | 2023-01-10 | by ( Andrea Shalal | ) www.reuters.com time to read: +5 min

WASHINGTON, Jan 10 (Reuters) - U.S. Treasury Secretary Janet Yellen is digging in to oversee billions of dollars in federal climate and infrastructure spending that she believes will transform the economy, close associates say, defying demands from Republicans to step down. Yellen told CNBC late last year that she was "in good company" in misjudging inflation, and that Biden's COVID spending plans were needed to boost the recovery. White House and Treasury officials say inflation was spurred by supply chain problems and exacerbated by Russia's invasion of Ukraine, but note that inflation is now easing and investments in manufacturing will reduce future supply chain log-jams. Treasury had no comment on the Republican concerns, but officials have previously said the department's policies are overdue and urgently needed. In addition to advancing Biden's domestic climate agenda, Treasury officials say another key priority for Yellen in 2023 will be advancing reforms of the World Bank and other multilateral lenders to free up more resources for countries to address climate change and other priorities.

☆ Eli Lilly has spent years and billions of dollars in search of an effective Alzheimer's drug. But success is not all or nothing for the stock
▼ + stars: | 2023-01-09 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +22 min

Eli Lilly (LLY) has spent decades researching Alzheimer's disease without successfully bringing to market a treatment that slows the memory-destroying condition. For Eli Lilly as a company, an Alzheimer's drug is an important pursuit. Lilly's Alzheimer's history Eli Lilly's "first real foray" into Alzheimer's came in the 1990s, according to Dr. John Sims, Eli Lilly's head of medical development for donanemab. Financial implications for Lilly LLY mountain 2021-10-08 The Club started a new position in Eli Lilly (LLY) in October 2021. The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

☆ U.S. EPA tightens soot standards for first time in decade
▼ + stars: | 2023-01-06 | by ( Valerie Volcovici | ) www.reuters.com time to read: +2 min

Fine particulate matter, or soot, comes from sources ranging from power plants to cars and trucks. It causes lung and heart damage and has been found to disproportionately affect low-income communities, according to EPA. "Fine particulate matter is both deadly and extremely costly," EPA Administrator Michael Regan told reporters, adding the decision was "based on sound science and a rigorous evaluation of the data that we have at hand." The EPA said it would also take public comment on revising the level to as low as 8 µg/m3, and as high as 11 µg/m3. The EPA also opted to retain the current primary 24-hour PM 2.5 standard of 35 µg/m3, despite a CASAC recommendation to lower that number to 25 µg/m3.

☆ Cannabis org The Parent Company establishes restructured partnership with Jay-Z's Roc Nation and SC Branding
▼ + stars: | 2023-01-05 | by ( John Lynch | ) www.businessinsider.com time to read: +6 min

The Parent Company and Jay-Z's Roc Nation and SC Branding have established a revised strategic agreement to restructure their partnership, the companies announced to Insider. Jay-Z, Roc Nation, and their affiliates will return approximately 7.1 million common shares of The Parent Company "to preserve shareholder value," the companies said. Through the agreement, The Parent Company will have an eight-year exclusive license to distribute Monogram, Jay-Z's cannabis line, in California. "We are excited for the continued growth of The Parent Company and our future together in the cannabis industry." Desiree Perez, CEO of Roc Nation, added, "We're eager to work alongside The Parent Company in this progressive capacity.

☆ FDA broke own protocols in approving Biogen Alzheimer’s drug, congressional report says
▼ + stars: | 2022-12-29 | by ( ) www.nbcnews.com time to read: +5 min

The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday. The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug. He pointed to the FDA’s internal review finding its staff’s interactions with Biogen appropriate. “As stated in the congressional report, an (FDA) review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,’” Biogen said. Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

Companies Biogen Inc FollowWASHINGTON, Dec 29 (Reuters) - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's (BIIB.O) Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday. The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug. He pointed to the FDA's internal review finding its staff's interactions with Biogen appropriate. "As stated in the congressional report, an (FDA) review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'" Biogen said. Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

☆ U.S. Accounting Rule Maker Looks to Advance Projects on Tax, Crypto and Expenses in 2023
▼ + stars: | 2022-12-28 | by ( Mark Maurer | ) www.wsj.com time to read: +5 min

The U.S. accounting rule maker in 2022 launched new projects following an agenda consultation with investors and other stakeholders in 2021, its first in five years. The board has at least three core projects—two on disclosure of expenses and one on disclosing income taxes—in 2023, according to Mr. Jones. PREVIEWThe FASB will likely finalize a rule in 2023 requiring public companies to start breaking out big-ticket expenses incurred by their business divisions, Mr. Jones said. Another major project Mr. Jones said might be finalized in 2023 would require companies to provide more tax details. “They have an important role in our economy.”The slowing economy will also be on the FASB’s radar, Mr. Jones said.

Dec 22 (Reuters) - Scott Minerd, global chief investment officer at investment and advisory firm Guggenheim Partners and a prominent Wall Street bond investor, has died, his firm said on Thursday. During his 25-year stint with Guggenheim, Minerd became a prolific commentator on financial markets and was often quoted by the media. He will be greatly missed by all," Mark Walter, chief executive and a founder of Guggenheim Partners, said in the firm's statement. Guggenheim said it had implemented a succession plan, with Anne Walsh, managing partner and CIO of Guggenheim Partners Investment Management, assuming many of Minerd's responsibilities on an interim basis. Minerd was regarded in the past few years as one of the U.S. "bond kings," along with Jeffrey Gundlach, chief executive of DoubleLine, and Dan Ivascyn, chief investment officer of bond giant PIMCO.

☆ Fact Check-COVID vaccinations did not ‘inject people’ with the next pandemic
▼ + stars: | 2022-12-21 | by ( Reuters Fact Check | ) www.reuters.com time to read: +3 min

There is no evidence to support a claim that COVID-19 vaccinations were a ploy to inject people with an infectious disease that will lead to a new pandemic. Fact sheets for the Janssen (J&J) and Novavax COVID-19 vaccine are available (here ) (here ). Ingredients described in the fact sheets for the Pfizer and Moderna vaccines include mRNA, lipids, sucrose and tromethamine, a chemical (here) (page 3), (here) (page 34). There is no evidence of the COVID-19 vaccines containing any substance that could cause an infectious disease pandemic. All vaccine ingredients, pharmacology and toxicology for COVID-19 vaccines approved in the United States are published online.

☆ Potential China wave is 'wild card' for ending COVID emergency - WHO advisors
▼ + stars: | 2022-12-20 | by ( Jennifer Rigby | ) www.reuters.com time to read: +5 min

"It's clear that we are in a very different phase [of the pandemic], but in my mind, that pending wave in China is a wild card." Last week, he told reporters in Geneva that he was "hopeful" of an end to the emergency some time next year. Tedros's earlier comments spurred hopes that the United Nations agency could soon remove the Public Health Emergency of International Concern (PHEIC) designation for COVID, which has been in place since January 2020. Some global health experts had expected China to wait for the WHO to lift the emergency status before easing its own pandemic response measures. WHO member states are currently working on re-designing the rules that govern global health emergencies to potentially address issues like this.

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