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☆ Exclusive-Eisai Expects 1,500 Alzheimer's Patients in China Launch, Sees ‘Huge’ Growth
▼ + stars: | 2024-02-04 | by ( Feb. | At P.M. | ) www.usnews.com time to read: +5 min

“China is one of the fastest-aging countries in the world and is one of the most important countries in the area of Alzheimer’s disease for Eisai,” a company spokesperson said. “The potential growth for Leqembi in China is huge.”Eli Lilly, which is developing a similar treatment called donanemab, told Reuters it has filed for approval in China. The Indianapolis-based company is now testing its drug in a 1,500-person trial with volunteers in China, Taiwan, South Korea and the EU, a spokesperson said. Leqembi, which works by removing a toxic protein called beta amyloid from the brain, is the first Alzheimer's treatment proven to alter the course of the fatal, brain-wasting disease. Once on treatment, suitable patients undergo a series of MRI scans to monitor for potentially fatal swelling and bleeding in the brain.

Persons: Julie Steenhuysen, Andrew Silver CHICAGO, ” Eli Lilly, Biogen, Liu Zhou, Eisai, ”, Hidemaru Yamaguchi, Soeren Mattke, Mattke, Andrew Silver, Caroline Humer, Bill Berkrot Organizations: Reuters, EU, Leqembi, Guangdong Medical University, ” Citi, Psychiatry, Siemens Healthineers, University of Southern, University of Southern California Brain Health Locations: SHANGHAI, China, ”, Leqembi, The Indianapolis, Taiwan, South Korea, Eisai, United States, Japan, Europe, U.S, University of Southern California, Chicago, Shanghai

☆ US obesity docs expect Lilly weight-loss drug to show similar heart benefit as Wegovy
▼ + stars: | 2023-12-01 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

REUTERS/Mike Segar Acquire Licensing RightsDec 1 (Reuters) - Some leading U.S. obesity specialists say they expect Eli Lilly’s (LLY.N) powerful weight-loss drug Zepbound will produce the same or similar heart benefits as Novo Nordisk’s (NOVOb.CO) popular Wegovy as they belong to the same class of medicines. In Novo's pivotal Wegovy trial involving 17,604 overweight and obese people without diabetes, the drug reduced incidence of heart attack, stroke or heart-related death by an impressive 20%. The product, which has the same active ingredient - tirzepatide - as its previously approved diabetes drug Mounjaro, is expected to start shipping it before the end of the year. They said they would readily prescribe Wegovy (semaglutide) if their patients' insurance did not cover Lilly’s drug, or if future trial results do not produce similar heart benefits. Lilly declined to comment on doctors' views that Zepbound might have the same or similar cardiovascular benefits as Wegovy.

Persons: Eli Lilly, Mike Segar, Eli Lilly’s, Lilly, Danish drugmaker, Edmond Wickham, Emily, Zepbound, Tirzepatide, ”, Rohit Kedia, Novo, Chad Weldy, semaglutide, tirzepatide, Farxiga, Boehringer Ingelheim, Lilly’s Jardiance, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Company, REUTERS, Novo, Wegovy, Virginia Commonwealth University . The, Virginia Commonwealth University . The U.S . Food, Drug Administration, Wall Street, Barclays, Providence, Stanford University, Thomson Locations: Branchburg , New Jersey, Danish, Virginia Commonwealth University . The U.S, Zepbound, U.S

Paxton said the claim was based on only two months of clinical trial data, and vaccine recipients' "absolute risk reduction" showed that the vaccine was just 0.85% effective. Infectious disease experts have said relative risk reduction is a more meaningful way to judge a vaccine's efficacy than absolute risk reduction. Relative risk shows how well a vaccine protects recipients relative to a study's control group. "Pfizer did not tell the truth about their COVID-19 vaccines," Paxton said in a statement. The status of the probe into Moderna and Johnson & Johnson was not immediately clear.

Persons: Dado Ruvic, Ken Paxton, Paxton, BioNTech, Biden, Johnson, Pfizer, Jonathan Stempel, Caroline Humer, Chizu Nomiyama, Daniel Wallis Organizations: Pfizer, REUTERS, Texas, Republican, Moderna, Johnson, Thomson Locations: Lubbock County, New York, Texas, Moderna

REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsNov 29 (Reuters) - Cigna (CI.N) and Humana (HUM.N), two of the biggest U.S. health insurers, are in talks for what could be the largest merger announced in 2023, according to a source familiar with the matter. A Humana and Cigna combination would give the merged company the scale to rival UnitedHealth Group (UNH.N) and CVS Health (CVS.N). In July 2016, the Justice Department filed lawsuits against two health insurance mergers on the same day, saying they would lead to less competition and higher prices for Americans. Health insurers have been facing higher medical costs as people return for procedures they had put off during the pandemic. Humana in February said that it would sell its commercial business but keep its Medicare Advantage products.

Persons: Andrew Kelly, Cigna, Cigna's, Aetna, Bill Baer, Andre Barlow of Doyle, Barlow, Mazard, Bernstein, Lance Wilkes, Craig Garthwaite, Manas Mishra, Diane Bartz, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Humana Inc, REUTERS, Street Journal, UnitedHealth, CVS Health, Humana’s, Medicare, Affordable, Justice Department, Humana, U.S ., Reuters, Northwestern University, Thomson Locations: Queens , New York City, U.S, Cigna, Bengaluru, Washington, Los Angeles

☆ Suspected fake Ozempic causes hypoglycemia in 11 in Lebanon
▼ + stars: | 2023-11-28 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

Three of the people who took the suspected fake Ozempic did so to control their diabetes, while four took it for weight management, Karam said. People with diabetes need to closely manage their blood sugar, which can be done with a variety of medicines including Ozempic. Lebanon's Ministry of Public Health issued two recalls related to Ozempic in January 2023, according to its website. Karam said Ozempic is neither purchased nor provided by the Ministry of Public Health. Several people have been hospitalized in Austria for hypoglycemia after taking potentially fake versions of Ozempic.

Persons: Rita Karam, Eli Lilly's, Novo's, Karam, Ozempic, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Lebanese Ministry of Public Health, Lebanon's Ministry of Public Health, Novo Nordisk, World Obesity, Obesity, International Diabetes Federation, Ministry of Public Health, Reuters, Thomson Locations: Lebanon, Germany, Egypt, Russia, United States, Novo, Britain, Belgium, Austria

☆ Researchers return to Alzheimer's vaccines, buoyed by recent drug success
▼ + stars: | 2023-11-20 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

The renewed interest in Alzheimer's vaccines follows a promising first attempt more than 20 years ago that was abandoned after 6% of study volunteers developed life-threatening brain inflammation known as meningoencephalitis. Dr. Reisa Sperling, an Alzheimer's researcher at Mass General Brigham in Boston, said she believes vaccines will play an important role as researchers look to prevent Alzheimer's. She is considering vaccines for her next study in asymptomatic people with Alzheimer's proteins in their blood, but not enough to register on brain scans. Alzheimer's vaccines are still in the early stages and will require large, years-long trials to show they work. Generating a strong immune response is critical for such vaccines, which would typically be given to older individuals with weaker immune systems, he said.

Persons: Brian Snyder, Eli Lilly's, Reisa Sperling, Brigham, “, ” Sperling, Walter Koroshetz, Mei Mei Hu, Vaxxinity, Hu, Michael Rafii, Rafii, Andrea Pfiefer, Johnson, Prothena, Gene Kinney, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Alzheimer Research, Brigham, Women's, REUTERS, Rights, U.S . Food, Drug Administration, Mass, National Institutes of Health, UB, University of Southern, Johnson, Bristol Myers Squibb, Thomson Locations: Boston , Massachusetts, U.S, Boston, Taiwan, University of Southern California

☆ Exclusive: Exxon aims to begin lithium production by 2026 in Arkansas
▼ + stars: | 2023-11-11 | by ( Ernest Scheyder | Thomson Reuters | Ernest Scheyder Is An Award-Winning Senior Correspondent Covering The Green Energy Transition | ) www.reuters.com time to read: +4 min

For Exxon and other oil companies, lithium production offers the prospect of selling a new product with relatively little added cost. OTHER ACREAGESeparate from its Tetra partnership, Exxon also controls more than 100,000 acres in Arkansas from which it plans to begin lithium production by 2027, according to the source. It was not clear whether Exxon plans to expand lithium operations outside Arkansas. Like all oil producers, Exxon extracts water containing traces of lithium as part of fossil fuel production. The Arkansas Oil and Gas Commission, which overseas lithium operations in the state, has said it plans to hold hearings on the matter.

Persons: Darren Woods, Mike Blake, Albemarle, Ernest Scheyder, Caroline Humer, David Gregorio Our Organizations: ExxonMobil, Milken, Global Conference, REUTERS, Exxon Mobil, Exxon, Tetra Technologies, EV, Reuters, Tetra, Chevron, Battery Metals, EnergySource Minerals, Energy, Arkansas Oil and Gas Commission, Benchmark Minerals, Thomson Locations: Beverly Hills , California, U.S, Arkansas, Florida, Texas, Albemarle, Louisiana, Los Angeles

☆ Pfizer RSV vaccine lags GSK’s as head-to-head competition underway
▼ + stars: | 2023-10-30 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

[1/3] View of Pfizer's new respiratory syncytial virus (RSV) vaccine Abrysvo during its manufacture in this undated handout picture. "800 POUND GORILLAS"CVS, which has more than 9,000 U.S. locations, declined to comment on why it was only carrying GSK's vaccine. It was not immediately clear how many RSV shots were being administered in pharmacies versus doctors' offices. GSK declined to discuss its RSV vaccine contracts, but said customer relationships gives it a competitive advantage. Two independent pharmacists said they are being charged a lower price by wholesalers for the GSK vaccine, which comes in boxes of 10.

Persons: Price, Ben Link, Link, Pfizer's, Dovato, Morningstar, Damien Conover, We’ve, Alison Hunt, Michelle Vargas, Michael Erman, Caroline Humer, Bill Berkrot Organizations: Pfizer, Handout, REUTERS, GSK, Reuters, CVS Health, CVS, Walgreens, Walmart, Aid, Thomson Locations: United States, British, U.S, South Carolina

Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea. "The market is in a shoot-first, ask-questions-later mood when it comes to weight-loss drugs," said Nicholas Anderson, manager of the Thornburg International Growth Fund, which holds shares of Novo Nordisk. By contrast, the iShares U.S. Medical Devices exchange-traded fund has lost more than 22% in the last three months. Injectable weight-loss drugs, known as GLP-1 receptor agonists, are considered highly effective but are also expensive, costing more than $1,300 per month. "Overall, we'll see an increased interest in bariatric surgery, but that will get delayed in the short term."

Persons: Doctor Thomas Horbach, Wegovy, Nicholas Anderson, Eli Lilly, Kenneth Stein, Margaret Kaczor Andrew, William Blair, Michael Farrell, Jeff Jonas, Johnson, Myriam Curet, Ann Hynes, Hynes, David Gaffen, Manas, Michael Erman, Caroline Humer, Sonali Paul Organizations: Novo Nordisk, Healthcare, Growth Fund, Medical Devices, Boston, Gabelli Funds, Johnson, Reuters, Mizuho Securities, Manas Mishra, Thomson Locations: Germany, Munich, Danish, U.S, Boston, GLP, New York, Bengaluru

Vaccine makers are depending on the U.S. market as many countries have more limited yearly campaigns for giving updated shots. For BioNTech, Moderna, and Novavax (NVAX.O), COVID vaccines remain their only approved products. Shares of Pfizer were up nearly 5%, however, buoyed by a $3.5 billion cost-cutting plan the drugmaker announced late on Friday alongside its new COVID sales outlook. Moderna, in a statement on Monday, maintained its current revenue forecast of $6 billion to $8 billion for its COVID vaccine for 2023. Jefferies analyst Michael Yee said Pfizer's new COVID outlook implies lower vaccine sales for Moderna than it had forecast.

Persons: Dado, BioNTech, Albert Bourla, Bourla, Mani Foroohar, Foroohar, Jefferies, Michael Yee, Ludwig Burger, Rachel More, Michael Erman, Bhanvi Satija, Manas, Jonathan Oatis, Caroline Humer, Bill Berkrot Organizations: COVID, Institute for Health, Food, REUTERS, Pfizer, Moderna, Manas Mishra, Thomson Locations: Zenica, Bosnia, Herzegovina, Frankfurt, Novavax, U.S, New York, Bengaluru

☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
▼ + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com time to read: +6 min

Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."

Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S

☆ Down syndrome families' fight for access to Alzheimer’s trials, treatments
▼ + stars: | 2023-10-10 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +9 min

In an extended portion of Eisai’s main Leqembi trial, CAA was associated with one death. 'THE DIGNITY OF RISK'Hillerstrom said the groups are "very strongly" lobbying Eisai and Lilly to conduct the safety trials in Down syndrome, and said he has been meeting with the companies to push them to design such trials. Lilly declined to comment on whether it is considering either a safety trial or taking part in that study. An Eisai spokeswoman said the company "has no immediate plans" to conduct clinical trials of Leqembi in people with Down syndrome. The company is collaborating with LuMind in a study gathering data on how Alzheimer's manifests in people with Down syndrome.

Persons: Oskar Hillerstrom, Lianor, Hampus, Brian Snyder, Lianor da Cunha, Oskar, de Oeiras, Teresa, Oskar’s, Hampus Hillerstrom, Eli Lilly's, LuMind, Hillerstrom, Lilly, Emily Largent, Beau Ances, Louis, I've, Ances, I'm, Michael Rafii, William Mobley, Mobley, Dawn Brooks, donanemab, Margot Rhondeau, Hannah, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: REUTERS, Rights, Reuters, CAA, University of Pennsylvania Perelman School of Medicine, Medicare, U.S . Food, Drug Administration, Washington University, National Institute, Aging, University of Southern, UC San Diego School of Medicine, LuMind, Syndrome, Thomson Locations: Lexington , Massachusetts, U.S, Santo, Portugal, United States, St, University of Southern California

☆ Kaiser healthcare unions say weeklong strike possible early next month
▼ + stars: | 2023-10-09 | by ( Steve Gorman | ) www.reuters.com time to read: +3 min

[1/2] Healthcare workers strike in front of Kaiser Permanente Los Angeles Medical Center, as more than 75,000 Kaiser Permanente healthcare workers go on strike from October 4 to 7 across the United States, in Los Angeles, California, U.S. October 4, 2023. The Coalition of Kaiser Permanente Unions said on Monday it has served the company notice that a weeklong "follow-up strike is possible" starting Nov. 1 unless the two sides come to a settlement beforehand. The company did not have an immediate response to the unions' latest strike deadline. The strike, which ran for three days, marked the largest work stoppage to date in the healthcare sector. Kaiser said it kept its hospitals and emergency departments open during the walkout, staffed by doctors, managers and "contingency workers."

Persons: Julie Su, Su, Kaiser, Steve Gorman, Sriparna Roy, Caroline Humer, Shinjini Ganguli, Matthew Lewis Organizations: Healthcare, Kaiser Permanente Los Angeles Medical Center, Permanente, REUTERS, Kaiser Permanente, Coalition, Kaiser Permanente Unions, Union, Kaiser, District of Columbia, Thomson Locations: United States, Los Angeles , California, U.S, Kaiser, California, California , Oregon, Washington, , Colorado, Virginia, Seattle, Los Angeles, Bengaluru

The U.S. government in May ended the COVID public health emergency declaration during which it bought the shots and provided them to all Americans for free. In the current privatized system, health insurance plans by law must cover the shots at no cost. McKesson (MCK.N), one of the largest U.S. wholesalers, said it has distributed over 3.8 million shots so far. "Health insurance providers continue to educate Americans about where and how to get their COVID vaccines within their plan’s coverage," David Allen, a spokesperson for insurance lobby group AHIP said. Now that the government is no longer footing the bill for their vaccine supply, pharmacy owners need to pay for the shots.

Persons: Kate MacDowell, MacDowell, Kaiser, David Allen, AHIP, David Kohll, James Daily, he's, Suzanne Berman, Michael Erman, Ahmed Aboulenein, Caroline Humer, Bill Berkrot Organizations: Pfizer, U.S . Department of Health, Human Services, Kaiser Permanente, COVID, Moderna, CVS, Walmart, Walgreens, Walgreens Boots Alliance, Cardinal Health, Reuters, Kohll's Pharmacy, Thomson Locations: WASHINGTON, U.S, Portland , Oregon, Oregon, California, Nebraska, Readington , New Jersey, Crossville , Tennessee, New York, Washington

☆ Explainer: What you need to know about RSV and the new vaccines
▼ + stars: | 2023-09-22 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

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

Benefit consultants from Mercer, Aon (AON.N) and Willis Towers Watson (WTW.O) see employer healthcare costs jumping 5.4% to 8.5% in 2024 due to medical inflation, soaring demand for costly weight-loss drugs and wider availability of high-priced gene therapies. Benefit consultants help design insurance plans for medium and large employers. About two-thirds of U.S. workers receive benefits through such plans.Insurers UnitedHealth (UNH.N), Centene (CNC.N), Cigna (CI.N) and Elevance (ELV.N), which manage employer insurance plans, declined to comment for this story. Of its projected 8.5% increase in employer healthcare costs for next year, Aon anticipates 1 percentage point coming from weight-loss drugs alone. Gene therapy treatment of just one employee could significantly raise costs for a company, consultants said.

Persons: Srdjan, Willis Towers Watson, Mercer, Marsh McLennan, Beth Umland, Aon, Novo's Ozempic, Eli Lilly's, Janet Faircloth, Jodi Picoult's, Khushi Mandowara, Leroy Leo, Caroline Humer, Bill Berkrot Organizations: U.S, REUTERS, Reuters Graphics, Novo, Reuters, Employers, Thomson Locations: Ljubljana, Mercer, Aon, United States, Bengaluru

The updated shots are part of a push by public health officials to align the next COVID vaccines more closely with the actual circulating variant of the virus, similar to the way annual flu shots are designed. The U.S. Food and Drug Administration (FDA) on Monday authorized updated COVID vaccines made by Pfizer (PFE.N) and its German partner BioNTech SE (22UAy.DE) as well as by Moderna (MRNA.O). CDC Director Mandy Cohen is expected to approve the recommendations issued by the advisers, allowing Americans to get the updated vaccines. The first COVID vaccines in 2020 were monovalent, or single-target vaccines, aimed at the original strain of the virus. They were followed by bivalent COVID vaccine booster shots that targeted both the original and the Omicron strains.

Persons: Emily Elconin, BioNTech, Caitlin Rivers, Mandy Cohen, Rivers, bivalent, Daniel Kuritzkes, Eris, Kuritzkes, Novavax, Bhanvi, Julie Steenhuysen, Will Dunham, Caroline Humer Organizations: REUTERS, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Pfizer, Moderna, FDA, Johns Hopkins Center for Health Security, CDC, Omicron, Brigham, Women's Hospital, Vaccine, EG, Thomson Locations: Waterford , Michigan, U.S, United States, Baltimore, Europe, Asia, Boston, Moderna, Bengaluru, Chicago

He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.

Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington

REUTERS/Shannon Stapleton/File Photo Acquire Licensing RightsLONDON/CHICAGO, Aug 24 (Reuters) - A highly mutated COVID variant called BA.2.86 has now been detected in Switzerland and South Africa in addition to Israel, Denmark, the U.S. and the U.K., according to a leading World Health Organization official. It has since been detected in other symptomatic patients, in routine airport screening, and in wastewater samples in a handful of countries. That the known cases are not linked suggests it is already circulating more widely, particularly given reduced surveillance worldwide, she said. There have been nine such cases detected as of Aug. 23 and the variant was also found in wastewater in Switzerland. Jha and others, including the European public health agency and COVAX, the global program for getting vaccines to the world's poorest, said COVID surveillance and defenses could be reactivated in the event of a major infection wave.

Persons: Shannon Stapleton, Maria Van Kerkhove, Kerkhove, ”, Marion Koopmans, Nirav Shah, Van Kerkhove, Tyra Grove Krause, Ashish Jha, Jha, Jennifer Rigby, Julie Steenhuysen, Pratik Jain, Caroline Humer, Bill Berkrot Organizations: REUTERS, Health Organization, Omicron, WHO, U.S . Centers for Disease Control, Pharmacy, Walgreens, Rite, Reuters, Statens Serum, White, Thomson Locations: Harlem, New York City, U.S, CHICAGO, Switzerland, South Africa, Israel, Denmark, COVID, Dutch, Danish, Bengaluru

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

☆ New Covid vaccines are on the way as 'Eris' variant rises
▼ + stars: | 2023-08-14 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

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

☆ Covid Eris: What to know about new variant EG.5 dominating U.S. cases
▼ + stars: | 2023-08-14 | by ( Michael Erman | ) www.reuters.com time to read: +2 min

NEW YORK, Aug 14 (Reuters) - COVID infections and hospitalizations are on the rise in the U.S., Europe and Asia. Health officials are pointing at the EG.5 "Eris" coronavirus, a subvariant of the Omicron lineage that originally emerged November of 2021. EG.5 had been found in more than 50 countries as of August 8, according to the WHO. It is the most common and fastest growing COVID-19 subvariant in the U.S., estimated to be responsible for around 17% of current COVID cases, according to the CDC. EG.5 is similar to XBB.1.5 although the newer subvariant carries one mutation to its spike protein, the part of the virus targeted by the vaccine.

Persons: Mandy Cohen, Cohen, Michael Erman, Caroline Humer, Diane Craft Organizations: Health, EG, Omicron, World Health Organization, WHO, CDC, Pfizer, Thomson Locations: U.S, Europe, Asia

☆ Insight: What happens when a $2 million gene therapy is not enough
▼ + stars: | 2023-08-12 | by ( Deena Beasley | ) www.reuters.com time to read: +13 min

Their experience raises broader questions around other high-cost gene therapies coming to market, sometimes after accelerated regulatory approvals, drug pricing experts said. Gene therapies work by replacing genes – the body's blueprint for its development. The gene Zolgensma delivers instructs the body to make a protein vital for muscle control. If gene therapies do fall short, it becomes harder to justify prices that researchers have argued are already poor value. More recently, the first hemophilia gene therapy approved by the U.S. Food and Drug Administration was priced by CSL Behring at $3.5 million; 26 more gene therapies are in late-stage development, according to IQVIA.

Persons: Elizabeth Kutschke, Ben, Zolgensma, Ben Kutschke, neurologists, Sitra Tauscher, Wisniewski, Ben's, Roger Hajjar, Brigham Gene, Kutschke, Vasant Narasimhan, Stacie Dusetzina, Roche's, Biogen, Roche, Maha Radhakrishnan, Steven Pearson, It's, Sree Chaguturu, Amanda Cook, Weston, Jackson, Cook, Elizabeth, Jerry Mendell, Russell Butterfield, –, Biogen's, Mendell, UMR, Spinraza, Eric Cox, Caroline Humer, Sara Ledwith Organizations: Reuters, U.S, Novartis, IQVIA Institute, Human Data, Novartis Gene Therapies, Mass, Cell Therapy, U.S . Food, Drug Administration, CSL Behring, CSL, Nashville's Vanderbilt University School of Medicine, Clinical, Economic, CVS Health, Aetna, SMA, Nationwide Children's Hospital, University of Utah Health, Children's, UnitedHealth, Thomson Locations: Oak Park, Berwyn , Illinois, Swiss, U.S, Lebanon , Virginia, United States, Columbus , Ohio, Russia, Kazakhstan, Chicago

☆ Obesity drug data could boost companies' case for US coverage, analysts say
▼ + stars: | 2023-08-10 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

Wegovy prescriptions were up 300% at their peak, according to data from Barclays, before supply issues began to hamper sales. A COMPELLING CASEAnalysts said the data made a compelling case for long-term health benefits of the drug. Analysts were divided on whether Medicare could potentially cover Wegovy as a cardiovascular treatment without a new law passing. Three doctors specializing in obesity treatment, including a cardiologist, were not sure whether such an indication would allow for Medicare coverage. Companies that provide healthcare insurance have begun pulling back on coverage of weight loss drugs because of the high cost of the medicines.

Persons: Read, Eli Lilly, Stacie Dusetzina, Wegovy, Eli Lilly's Mounjaro, Evan Seigerman, Eugene Yang, Morningstar, Damien Conover, Tom Carper, Eli Lilly's, Dusetzina, Patrick Wingrove, Elissa Welle, Ahmed Aboulenein, Caroline Humer Organizations: Novo Nordisk, U.S, Vanderbilt University, Medicare, Barclays, University of Washington Medicine, Companies, Democratic, Novo, Reuters, Democrat, Republican, Thomson Locations: New York, Danish, Washington

☆ Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks
▼ + stars: | 2023-07-31 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +11 min

The company told Reuters that 49% of Black volunteers did not meet the trial's amyloid threshold requirements compared to 22% for whites and 55% for Hispanics. "Is it because MCI (mild cognitive impairment) or early dementia type-symptoms in Blacks are caused by other reasons more so than Alzheimer's?" In 96 dementia trials from 2000-2017, diverse populations only made up around 11% of enrollment, according to a 2018 study. Among Black people who died of Alzheimer's, their dementia was more likely to result from multiple causes, such as vascular disease. "Is it that it's not Alzheimer's disease?

Persons: Barrington, Vickie Riley, Charlie, Harriet Shaffer, Barrington Riley, –, Eli Lilly, Lilly, Crystal Glover, Eisai, Ivan Cheung, Cheung, Shobha, Biogen, Mark Mintun, Alzheimer's, Dr Lisa Barnes, Barnes, Joshua Grill, we're, Reisa Sperling, Brigham, Julie Steenhuysen, Caroline Humer, Suzanne Goldenberg, Daniel Flynn Organizations: Emory University Brain Health, Americans, Reuters, Prospective Black, Rush, Disease Research, and Drug Administration, FDA, Black, MCI, National Institutes of Health, Rush Center, University of California, Women's Hospital, Thomson Locations: Atlanta , Georgia, U.S, Chicago, Tokyo, Irvine, United States

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