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Nicknamed "Pirola" on social media, the BA.2.86 Omicron subvariant is being tracked by both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). As of Aug. 30, CDC said the BA.2.86 variant was detected in at least four U.S. states in people or wastewater. Delaware on Tuesday said it had detected a BA.2.86 infection at a hospital. Moderna on Wednesday said clinical data showed that its retooled COVID vaccine generated a nearly 9-fold increase in human antibodies that can neutralize BA.2.86. Pfizer said on Wednesday that its updated COVID shot showed neutralizing activity against BA.2.86 and EG.5 in studies conducted on mice.

Persons: Emily Elconin, David Dowdy, Dowdy, Dan Barouch, David Ho, Deena Beasley, Julie Steenhuysen, Bill Berkrot Organizations: REUTERS, Moderna, Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, CDC, EG, Omicron, East, Johns Hopkins Bloomberg School of Public Health, Center, Virology, Vaccine, Beth Israel Deaconess Medical, Columbia University, U.S . Food, Drug Administration, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, Delaware, East Coast, Boston, Sweden, China

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

"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.

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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