Health News Roundup: FDA issues marketing denial for 6,500 flavored e-cigarettes; G7 plans new vaccine effort for developing nations, Yomiuri reports and more

The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action. US FDA approves Astellas Pharma pill for menopause hot flashes The U.S. Food and Drug Administration on Friday approved Japanese drugmaker Astellas Pharma Inc's oral drug Veozah for the treatment of hot flashes associated with menopause.

Following is a summary of current health news briefs.

Eisai, Biogen Alzheimer's drug Leqembi would cost US Medicare up to $5 billion a year, study finds

Wide coverage of Alzheimer's drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, according to a study led by researchers at the University of California, Los Angeles (UCLA). Leqembi, sold by partners Eisai Co Ltd and Biogen Inc at an annual list price of $26,500, was approved this year under the U.S. Food and Drug Administration's accelerated pathway. Trial results later showed it slowed the rate of cognitive decline by 27% compared with a placebo in patients with early disease.

US FDA advisers narrowly back Sarepta's Duchenne gene therapy for accelerated approval

Advisers to the U.S. Food and Drug Administration on Friday narrowly recommended that the agency grant accelerated approval to Sarepta Therapeutics Inc's first-of-its-kind gene therapy for Duchenne muscular dystrophy (DMD). Eight expert advisers voted in favor of the therapy, and six against.

FDA issues marketing denial for 6,500 flavored e-cigarettes

The U.S. Food and Drug Administration (FDA) on Friday issued marketing denial orders to 10 companies which collectively manufacture and market about 6,500 flavored e-liquid and e-cigarette products. The health regulator said these companies cannot market or distribute the products in the U.S. and retailers who sell them risk FDA enforcement action.

US FDA approves Astellas Pharma pill for menopause hot flashes

The U.S. Food and Drug Administration on Friday approved Japanese drugmaker Astellas Pharma Inc's oral drug Veozah for the treatment of hot flashes associated with menopause. Hormonal changes during menopause make the body more sensitive to fluctuations in body temperature, causing so-called vasomotor symptoms, or hot flashes and night sweats.

G7 plans new vaccine effort for developing nations, Yomiuri reports

The Group of Seven (G7) rich nations is set to agree on establishing a new programme to distribute vaccines to developing countries at next week's summit of leaders, Japan's Yomiuri newspaper said on Saturday. In addition to the G7, G20 nations such as India and international groups such as the World Health Organization (WHO) and the World Bank will participate, it added, citing Japanese government sources.

(With inputs from agencies.)