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☆ U.S. regulators rejected Elon Musk’s bid to test brain chips in humans
▼ + stars: | 2023-03-02 | by ( ) www.reuters.com time to read: +23 min

Musk’s missed deadlines for FDA approval of Neuralink July 2019:Musk says Neuralink is aiming to receive regulatory approval for human trials of brain implants by the end of 2020. “Everybody in the industry was saying: ‘Oh my God, they’re going to run straight into a brick wall,’” Ludwig said of Musk’s bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company’s launch. The FDA’s concerns about the battery are also potentially serious, experts in brain devices said. Still, that proposal disappointed Neuralink because it could delay progress toward final FDA approval, one of the sources said.

☆ What happens to the human brain during a near-death experience that can trigger vivid memories and bizarre spiritual encounters
▼ + stars: | 2023-01-18 | by ( Erin Heger | ) www.businessinsider.com time to read: +8 min

But people who have had a near-death experience (NDE) typically report feeling peace, comfort, and calm throughout the ordeal. What a near-death experience feels likeNDEs can trigger a lot of peculiar sensations, including feeling like you're floating above your body or an out-of-body experience. What a near-death experience does to the brainThe temporal lobe, highlighted here, is responsible for language and visual memory, among other things. It might differ based on cultural or spiritual beliefs, but it is essentially the same," San Filippo said. "That leads us to believe that a near-death experience is a transpersonal experience happening outside of the brain."

[1/2] GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. Circuit Court of Appeals ruled that federal law preempts the plaintiffs' state-law claims that GSK failed to warn doctors and pregnant women that animal studies found a link between birth defects and taking Zofran. Louis Bograd, a lawyer for the plaintiffs at Motley Rice, did not respond to a request for comment. Without any newly acquired information, GSK could not legally change the label without the FDA's blessing, Kayatta wrote. For the plaintiffs: Louis Bograd of Motley RiceFor GSK: Lisa Blatt of Williams & ConnollyRead more:Zofran birth defect cases should be revived, say hundreds of plaintiffsGSK defeats 425 lawsuits alleging Zofran causes birth defects(NOTE: This story has been updated with a comment from GSK.)

☆ Fact Check-There is no proof ultrasounds harm babies or mothers
▼ + stars: | 2022-12-16 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

There is no evidence to suggest that ultrasound examinations during pregnancy are dangerous to fetuses, as some social media posts have falsely said. Experts contacted by Reuters said there were no signs of any increases in deaths or distress among babies or mothers who had standard ultrasounds or the more powerful Doppler ultrasound under medical supervision. A Doppler ultrasound also uses sound waves, but can also check blood flow. “Animal studies cannot be used as evidence as the ultrasound effects cannot be scaled and a small animal will suffer from much greater effects than human babies,” he said. Studies of ultrasounds used in human pregnancies have not found evidence of danger to the health of babies or mothers.

☆ Japan's Shionogi shares jump after report of COVID drug gaining efficacy approval
▼ + stars: | 2022-11-22 | by ( ) www.reuters.com time to read: +1 min

Regulators in Japan previously denied emergency approval for the Shionogi pill, saying they wanted to see more data on its effectiveness. There were also concerns the drug could pose risk to pregnancies, based on results from animal studies. If approved, it would become the first domestically developed oral drug for COVID patients with mild symptoms. Despite the delay in approving the treatment, Shionogi last month raised its full-year sales forecast on expectations it would win regulatory approval. The company has signed an agreement to sell about a million doses to the government, pending the drug's approval.

☆ Brett Favre helped an experimental drug maker get $2M in welfare money. Experts doubt the drug can work.
▼ + stars: | 2022-11-21 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Dilanianmug.Jpg | Ken Dilanian | ) www.nbcnews.com time to read: +7 min

And he did more than evangelize, court records show — he successfully lobbied Mississippi state officials who granted the company $2.1 million in federal welfare money that was intended to help poor families. The payment was illegal, state officials allege in a lawsuit — part of a huge Mississippi welfare misspending scandal that has tarnished Favre’s reputation. Favre, who is being sued by Mississippi, has consistently said that he did not know the money he was seeking from the Mississippi Department of Human Services—the state welfare agency—was welfare money. Six people have been charged in what state and federal officials call a massive fraud scheme, including the former director of the state welfare agency, who is cooperating with the FBI and federal prosecutors. Favre is among 38 defendants in a civil lawsuit by the state seeking to recoup the welfare money, including the funds devoted to the volleyball facility and the unproven concussion drug.

☆ Pfizer releases more data indicating omicron boosters are better than old Covid shots
▼ + stars: | 2022-11-04 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

Pfizer and BioNTech also found that people with and without prior Covid infections had a significant increase in their antibody levels after the omicron boosters. Pfizer and BioNTech released more human data Friday indicating the omicron BA.5 boosters perform better than the old Covid shots. Pfizer and BioNTech released the first human data in October showing the omicron boosters trigger a better immune response. They found the new boosters and the old shots performed about the same against omicron BA.5. The scientific community and public health officials are closely following data on the boosters because the FDA authorized them without direct human data.

☆ New RSV vaccines may soon put an end to rough seasons
▼ + stars: | 2022-10-31 | by ( Brenda Goodman | ) edition.cnn.com time to read: +15 min

The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies. In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them. Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine. The vaccines for pregnant women are meant to get newborns through their first RSV season.

☆ FDA says two studies showing omicron boosters weren't much better than old Covid shots were too small to come to any conclusions
▼ + stars: | 2022-10-28 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The recently authorized booster vaccine protects against the original SARS-CoV-2 virus and the more recent omicron variants, BA.4 and BA.5. The Food and Drug Administration said two studies this week showing that the new omicron boosters weren't that much better than the old shots were too small to come to any real conclusions. The antibody responses were slightly higher with the omicron boosters, though the studies concluded the difference wasn't significant. The studies are of public interest because there's very limited human data on how the omicron BA.5 boosters perform right now. The FDA also looked at data directly on the BA.5 shots that came from animal studies.

☆ Pfizer says omicron shots substantially boosted antibodies against BA.5 subvariant in early human data
▼ + stars: | 2022-10-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Pfizer and its German partner BioNTech on Thursday said their new omicron boosters substantially increased protective antibodies against the dominant omicron BA.5 subvariant for adults in the first direct human data released to the public on the new shots. The participants who received the first generation vaccine saw a limited increase in antibodies against BA.5, according to the companies. The early data indicate that the safety profile of the new boosters is the same as the original vaccine, the companies said. The first generation shots were developed only against the first strain of the virus. The FDA authorized the omicron shots without direct human data on how they perform against omicron BA.5, which is causing most infections in the U.S. right now.

☆ Shionogi says COVID pill trial shows reduction in symptoms
▼ + stars: | 2022-09-28 | by ( ) www.reuters.com time to read: +2 min

TOKYO, Sept 28 (Reuters) - Japan's Shionogi & Co Ltd (4507.T) said on Wednesday its oral treatment for COVID-19 demonstrated a significant reduction in symptoms compared with a placebo in a Phase III trial in Asia. Regulatory authorities in Japan previously denied emergency approval for use of the pill, saying they wanted to see more data on its effectiveness. read moreShionogi said it has shared top-line data from the Phase III study with Japanese regulators as part of deliberations on approval of the drug. The company has signed an agreement to sell about a million doses to the government, pending the drug's approval. The firm has received U.S. government support for a global Phase III trial.

☆ Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11
▼ + stars: | 2022-09-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Pfizer on Monday asked the Food and Drug Administration to authorize its new Covid booster shots that target the omicron BA.5 subvariant for children ages 5 to 11. The company, in a statement, said its request is based on human data from a similar vaccine that targets the omicron BA.1 subvariant and data from animal studies on the BA.5 shots. Pfizer's main competitor on Covid shots, Moderna, asked the FDA to authorize its omicron shots for kids ages 6 through 17 on Friday. Officials at the FDA and CDC expect the omicron BA.5 shots will provide significantly better protection against infection and disease this fall and winter. The new boosters target the dominant omicron BA.5 subvariant as well as the original strain of Covid that first emerged in Wuhan, China in 2019.

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