Health News Roundup: EU regulator accepts for review Alzheimer's treatment from Eisai-Biogen; U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot and more

The drug, lecanemab, which was recently granted accelerated approval in the United States, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of patients in the early stages of the mind-wasting disease. FDA advisers back the same COVID vaccine for initial shots, boosters Advisers to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of targeting the same coronavirus strain for initial COVID-19 vaccine doses and boosters going forward, but some expressed skepticism about whether all Americans need to receive the shots annually.

Following is a summary of current health news briefs.

EU drug regulator decides antibiotic shortage not a 'major event'

Europe's drug regulator has decided not to label the antibiotic shortage on the continent a "major event", given existing measures to tackle the shortfall were working in the short term, it said in a statement on Thursday, A "major event" label would allow the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.

EU regulator accepts for review Alzheimer's treatment from Eisai-Biogen

Japanese drugmaker Eisai Co Ltd and Biogen Inc said on Thursday the European Medicines Agency (EMA) had accepted a marketing authorization application for their Alzheimer's disease drug. The drug, lecanemab, which was recently granted accelerated approval in the United States, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of patients in the early stages of the mind-wasting disease.

FDA advisers back the same COVID vaccine for initial shots, boosters

Advisers to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of targeting the same coronavirus strain for initial COVID-19 vaccine doses and boosters going forward, but some expressed skepticism about whether all Americans need to receive the shots annually. The agency is trying to simplify its COVID-19 vaccine policy as it considers whether to recommend Americans get an annual booster shot for the virus. But several members of the expert advisory group asked for more robust data on benefits of annual shots for younger, healthier people.

U.S. CDC still looking at potential stroke risk from Pfizer bivalent COVID shot

New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer/BioNTech COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday. U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.

Sanofi's and Regeneron's Dupixent wins new stage of EU regulatory approval

Healthcare companies Sanofi and Regeneron said on Friday the European Union's medicines regulator had given a new stage of approval for their Dupixent product to treat children as young as 6 months old with severe atopic dermatitis. The European Commission is expected to announce a final decision on the Dupixent application in coming months. Dupixent was approved in June 2022 by the U.S. Food and Drug Administration (FDA) regulator for children in this age group.

U.S. FDA calls for new regulatory framework for use of cannabis compound CBD

The U.S. Food and Drug Administration said on Thursday it does not intend to make any new guidance on the use of the popular cannabis compound CBD in food and supplements, saying the United States needs to develop a new framework to ensure its safe use. The health regulator said it would work with Congress to develop a new, cross-agency regulatory framework. The FDA denied three citizen petitions that had requested the agency to provide guidance.

HCA Healthcare forecasts lower-than-expected 2023 profit

HCA Healthcare Inc on Friday forecast lower-than-expected profit for this year, citing impact from the COVID-19 pandemic and high inflation. People usually delay non-urgent medical procedures, which provide high margins for hospitals, during weak macroeconomic conditions, like high inflation.

Exclusive-EU may pay more for Pfizer COVID shots in return for lower volume

Brussels is discussing with Pfizer and BioNTech the possibility of reducing the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price, a source with knowledge of the talks said. Also on the table is an extension of the deadline for delivery, possibly to the second half of 2024, the source said. They declined to be identified because the talks are confidential.

VP Harris hosts White House summit to replace lead pipes

U.S. Vice President Kamala Harris will host a summit at the White House on Friday to speed up the removal of lead pipes across America - an issue she has previously called a public health crisis. Harris will be joined by U.S. Environmental Protection Agency (EPA) Administrator Michael Regan, along with other representatives from state and local government, water utilities, labor leaders, NGOs, and the private sector, a White House official said.

Japan to downgrade coronavirus classification on May 8, PM Kishida says

Japan has decided to downgrade its classification of COVID-19 to that of a less serious disease on May 8, revising its measures against the coronavirus such as relaxing guidance that people wear masks in public indoor places, Prime Minister Fumio Kishida said on Friday. The government last revised coronavirus measures in May 2022.

(With inputs from agencies.)