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☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

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.

☆ US declines to force lower price on cancer drug Xtandi
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

WASHINGTON, March 21 (Reuters) - The U.S. government will not force Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency "march-in" authority, the National Institutes of Health (NIH) said on Tuesday. Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug's price in March 2016. The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available. "NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," the letter said. Progressive lawmakers in the Democratic Party have been calling on President Joe Biden's administration to use its march-in authority to lower drug prices.

☆ Analysis: Why public health officials are not panicked about bird flu
▼ + stars: | 2023-02-23 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

They say the attributes that have made this virus thrive in wild birds likely make it less infectious to people. Although the exact changes required for a bird flu virus to become easily transmissible in people are not known, a pair of landmark studies done a decade ago offer some clues. Mink have both avian and human-type receptors, but avian receptors are scarce in humans and located deep in the lungs. That change is a must if a bird flu virus is to spread easily in people. None of the experts discounted the possibility that H5N1 or another avian flu virus could mutate and spark a pandemic, and many believe the world has not seen its last flu pandemic.

☆ Infected in the first wave, they navigated long COVID without a roadmap
▼ + stars: | 2023-02-20 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Three years later, at least 65 million people worldwide are estimated to have long COVID, according to an evidence review published last month in Nature Reviews Microbiology. An analysis of thousands of health records by the RECOVER trial found that non-Hispanic white women in wealthier areas were more likely than others to have a long COVID diagnosis. Researchers said that likely reflected disparities in access to healthcare, and suggests that many cases of long COVID among people of color are not being diagnosed. She has since been diagnosed with long COVID and can no longer work. Other infections such as Lyme disease can result in long-term symptoms, many of which overlap with long COVID.

"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults ages 65 and older. Moderna, Pfizer Inc (PFE.N) and GSK Plc (GSK.L) are racing to get their RSV vaccines to market first. Pfizer's RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. "It's very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well," Hoge said. The RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States, according to Cowen analyst Tyler Van Buren.

In 2022, drugmakers raised prices on more than 1,400 drugs according to data published by 46brooklyn, a drug pricing non-profit that is related to 3 Axis. The median drug price increase was 4.9% last year, while the average increase was 6.4%, according to 46brooklyn. Antonio Ciaccia, president of 3 Axis, said that drugmakers have focused on launching their drugs at higher prices because of the attention paid to annual price increases. More drug prices are likely to be announced over the course of January - historically the biggest month for drugmakers to raise prices. Sanofi plans to raise prices on 14 of its drugs or vaccines.

The United States this week also expanded its voluntary genomic sequencing program at airports, adding Seattle and Los Angeles to the program. "Previous COVID-19 wastewater surveillance has shown to be a valuable tool and airplane wastewater surveillance could potentially be an option," she wrote. French researchers reported in July that airplane wastewater tests showed requiring negative COVID tests before international flights does not protect countries from the spread of new variants. They found the Omicron variant in wastewater from two commercial airplanes that flew from Ethiopia to France in December 2021 even though passengers had been required to take COVID tests before boarding. Osterholm and others said mandatory testing before travel to the United States is unlikely to keep new variants out of the country.

Although many public health experts are expressing concern about the rising COVID cases in China, infectious disease experts have been increasingly worried about the XBB.1.5 variant. Recombinants of the BA.2 variant, XBB and XBB.1.5, together accounted for 44.1% of the total cases in the country for the week ended Dec. 31. For the week ended Dec.24, XBB.1.5 had made up 21.7% of the total cases. The XBB variant has been driving up cases in parts of Asia, including Singapore. It accounted for 3.6% of the total cases in the U.S. this week compared with 4.2% in the previous week.

☆ U.S. to impose mandatory COVID-19 tests for travelers from China
▼ + stars: | 2022-12-28 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

CHICAGO, Dec 28 (Reuters) - The United States will impose mandatory COVID-19 tests on travelers from China, U.S. health officials said on Wednesday, joining India, Italy, Japan and Taiwan in taking new measures after Beijing's decision to lift stringent zero-COVID policies. The United States also is expanding its voluntary genomic sequencing program at airports, adding Seattle and Los Angeles to the program. Beijing has faced international criticism that its official COVID data and its tally of deaths are inconsistent with the scale of its outbreak. In June, the United States rescinded a 17-month-old requirement that people arriving in the country by air test negative for COVID-19. It still requires most non-U.S. citizens to be vaccinated against COVID to travel to the United States.

The methods for counting COVID deaths have varied across countries in the nearly three years since the pandemic began. CAN CHINA'S COVID DATA BE TRUSTED? With one of the lowest COVID death tolls in the world, China has been routinely accused of downplaying infections and deaths for political reasons. Globally, the study estimated 18.2 million excess deaths in 2021-2022, compared with reported COVID deaths of 5.94 million. China actually cut its accumulated death toll by one on Dec. 20, bringing the total to 5,241.

☆ Beijing braces for surge in severe COVID cases as world watches with concern
▼ + stars: | 2022-12-21 | by ( Bernard Orr | ) www.reuters.com time to read: +5 min

[1/4] People wearing face masks commute in a subway station during morning rush hour, following the coronavirus disease ( COVID-19) outbreak, in Beijing, China January 20, 2021. China, which uses a narrow definition of what can be classified as COVID fatalities, reported no new COVID deaths for Dec. 20, compared with five the previous day. Severe cases rose by 53 across China on Tuesday, versus an increase of 23 the previous day. China does not provide absolute figures of severe cases. Blood clots, heart problems and sepsis - an extreme body response to infection - have caused countless deaths among COVID patients around the world.

[1/2] People line up at a makeshift fever clinic set up inside a stadium, amid the coronavirus disease (COVID-19) outbreak in Beijing, China December 19, 2022. "We stand ready to help any country in the world with vaccines, treatments, anything else that we can be helpful with," he said. "We want China to get COVID right," Blinken said earlier this month. “China faces a very challenging system in reopening,” Powell said, adding that its manufacturing, exporting and supply chain remain critical. Officials set up health centers and apps that told people with symptoms how to avoid infecting others, he said.

According to the group's projections, cases in China would peak around April 1, when deaths would reach 322,000. About a third of China's population will have been infected by then, IHME Director Christopher Murray said. China's national health authority has not reported any official COVID deaths since the lifting of COVID restrictions. Based on China's population of 1.41 billion, and without measures such as a mass vaccination booster campaign, that amounts to 964,400 deaths. China's National Health Commission said on Friday it was ramping up vaccinations and building stocks of ventilators and essential drugs.

"The jury is still out," on which technology will dominate, said Dr. Sadik Esener, director of the Cancer Early Detection Advanced Research Center at the OHSU Knight Cancer Institute in Portland, Oregon. He added it could take as long as 20 years to show that an early cancer detection test saved lives. If proven to work, early cancer detection tests could help doctors identify cancer risk in patients long before symptoms or other indicators develop. DIFFERENT APPROACHESSeveral of the leading contenders take vastly different approaches to cancer detection and it is not yet clear which methods will prove most useful or when. Some are working on blood tests to detect different markers of early cancer, including proteins.

☆ Eisai, Biogen Alzheimer's drug slows cognitive decline, safety for some becomes focus
▼ + stars: | 2022-11-30 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. He suggested that could be because homozygous study patients who were given a placebo fared better than expected. Overall, lecanemab patients benefited by 23% to 26% compared with a placebo on these secondary trial goals. Detailed data from the study were presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco and published in the New England Journal of Medicine. Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies.

☆ Rare success for Alzheimer's research unlocks hope for future therapies
▼ + stars: | 2022-11-29 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago. But several antibody therapies from Lilly, Biogen and AbbVie(ABBV.N) that were designed to slow the rate of tau accumulations failed outright last year.

☆ U.S. flu hospitalizations highest in 10 years, officials say
▼ + stars: | 2022-11-04 | by ( ) www.reuters.com time to read: +1 min

The rising flu cases come alongside pressure on hospitals from respiratory syncytial virus (RSV) and COVID cases, officials said, urging people to get vaccinated and offering to assist states that may need additional support. There have been 5 million fewer doses of influenza vaccine administered to U.S. adults so far this year compared to this time last year, officials said. Flu vaccine uptake is about the same for children this year but overall is down 6% compared to before the COVID pandemic began in 2020. About 5% fewer pregnant people have received flu shots so far this season, which officials say is especially worrisome because the vaccine protects both the expecting mother and her baby, officials added. U.S. flu shots are made by Sanofi SA (SASY.PA), GSK (GSK.L) and Seqirus, a unit of CSL Ltd (CSL.AX)Reporting by Julie Steenhuysen and Susan Heavey; Editing by Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

☆ Factbox: What are the new BQ.1 and BQ.1.1 coronavirus variants, and why it matters
▼ + stars: | 2022-11-04 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +3 min

The following describes the new coronavirus subvariants and how they may impact people. WHAT ARE BQ.1 AND BQ.1.1? In early July, BA.5 became the dominant subvariant of the coronavirus circulating in the United States, but in October it started giving way to BQ.1 and BQ.1.1. A study of blood from three dozen adults showed the shot increased neutralizing antibodies against the BA.4/BA.5 Omicron subvariants by fourfold compared with the original shot after one month. read moreIt is not yet clear whether that will translate into higher protection against the BQ.1 and BQ.1.1 subvariants, but their close relationship to BA.5 may work in the booster's favor.

☆ U.S. government to test Pfizer's Paxlovid for long COVID
▼ + stars: | 2022-10-27 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +2 min

According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer's treatment or a placebo in 1,700 volunteers aged 18 and older. The trial will investigate a leading theory of the cause of long COVID, which holds that fragments of the virus persist in the tissues of some individuals, causing prolonged symptoms. Patients in several case studies have reported improvements in their symptoms after taking Pfizer's antiviral treatment, and several physicians have called for the drug to be studied in a large, scientifically rigorous study in patients with long COVID. Estimates of long COVID prevalence range from 5 to 50% of people who have had a COVID-19 infection. It affects people who have had both mild and severe COVID-19, including children, and can be severe enough to keep people out of work.

☆ Addiction drug shows promise lifting long COVID brain fog, fatigue
▼ + stars: | 2022-10-18 | by ( Julie Steenhuysen | Nancy Lapid | ) www.reuters.com time to read: +6 min

Lauren Nichols, who has long COVID, takes a break and rests in a lounge bed in the office in her home in Andover, Massachusetts, U.S., August 3, 2022. Register now for FREE unlimited access to Reuters.com RegisterResearchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection. Younger, author of a scientific review of the drug as a novel anti-inflammatory, in September submitted a grant application to study LDN for long COVID. It worked so well that he ran a pilot study among 38 long COVID patients. He studied LDN in 18 long COVID patients, with 11 showing improvements, and said he believes larger, formal trials could determine whether LDN offers a true benefit.

☆ U.S. sends experimental antibody, antiviral drug to Uganda for Ebola outbreak
▼ + stars: | 2022-10-18 | by ( Julie Steenhuysen | Nancy Lapid | ) www.reuters.com time to read: +3 min

There are currently no proven vaccines or treatments for the Sudan species of Ebola, one of four known Ebola viruses to cause hemorrhagic fever in humans. The outbreak confirmed by the Ugandan health ministry on Sept. 20 is the largest of the Sudan species since 2000. "If healthcare workers start to fall ill and die, it's going to negatively impact the response," said Montgomery, who had just returned from a trip to Uganda. For instance, healthcare workers may be reluctant to assist in the response, he said in a phone interview. A large outbreak of the Zaire species of Ebola in West Africa from 2014-2016 led to effective vaccines and treatment, but there are no proven treatments or vaccines for the Sudan species.

Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer's drug, were up 6.7% in after hours trade. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. Symptomatic brain swelling was seen in 2.8% of those in the lecanemab group and none of the placebo group, they said. Aduhelm's approval was a rare bright spot for Alzheimer's patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost. Other plaque-targeting antibodies in late-stage development for Alzheimer's patients include Roche Holding AG's (ROG.S) gantenerumab and Eli Lilly's donanemab.

Globally, the figure could reach 139 million by 2050 without an effective treatment, Alzheimer's Disease International said. Aduhelm was the first new Alzheimer's drug approved in 20 years after a long list of high-profile failures for the industry. read morePatient advocacy groups hailed the news of positive lecanemab trial results. Micro hemorrhages in the brain occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group. Aduhelm's approval was a rare bright spot for Alzheimer's patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.

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