Health News Roundup: U.S. FDA staff flags unclear benefits of Ardelyx's kidney disease drug; Roche's Alzheimer's drug fails to meet goal in long awaited trial and more
The FDA's staff reviewers said, "the magnitude of treatment effect appears less than that observed with approved drugs," in briefing documents released on Monday. Factbox-Roche's drug failure extends long list of Alzheimer's trial setbacks Roche Holding AG reported on Monday that its Alzheimer's drug candidate, gantenerumab, did not meet main goals of studies, marking another setback for companies trying to find an effective treatment for the memory-robbing disease.
Following is a summary of current health news briefs.
Less and late: UK gives $1 billion to global disease fight
The British government said on Monday it would contribute 1 billion pounds ($1.18 billion) to the Global Fund to fight AIDS, tuberculosis and malaria, more than six weeks after other countries made their commitments. The total, which covers 2023-25, is 30% less than Britain pledged during the previous funding round in 2019, and below the 1.8 billion pounds requested this time.
Germany's BioNTech says to set up mRNA vaccine facility in Singapore
BioNTech SE, the German biotech that developed a widely used COVID-19 vaccine with Pfizer Inc, acquired a manufacturing facility in Singapore, its first in Asia, the company said on Monday. The facility, bought from a Novartis unit, will be its first messenger ribonucleic acid, or mRNA, facility in Singapore and support its vaccines production for the Asia Pacific region, BioNTech said in a statement, without disclosing financial details.
Explainer-To mask or not to mask? G20 gathers nations with divergent COVID rules
Nearly three years into the COVID-19 pandemic, leaders of G20 countries are gathering on the Indonesian resort island of Bali with strict testing and masking requirements, even though such measures have been largely dropped in some member countries. It is Chinese President Xi Jinping's first G20 summit - and only his second trip abroad - since the start of the pandemic as his country continues its zero-COVID policy of lockdowns and quarantine that are among the world's strictest.
U.S. judge rejects Biden administration's LGBT health protections
A federal judge in Texas ruled on Friday that President Joe Biden's administration had wrongly interpreted an Obamacare provision as barring health care providers from discriminating against gay and transgender people. U.S. District Judge Matthew Kacsmaryk in Amarillo ruled that a landmark U.S. Supreme Court decision in 2020 holding that a law barring workplace discrimination protects gay and transgender employees did not apply to the healthcare law.
South Africa reports bird flu outbreak on small farm - WOAH
South Africa reported an outbreak of highly pathogenic H5N2 bird flu on a farm in the eastern part of the country, the Paris-based World Organisation for Animal Health (WOAH) said on Monday, citing a report from local authorities. Some 58 "domestic birds" of a total flock of 200 were found dead of the highly contagious virus, the report said, without giving additional details on the type of birds.
Moderna's Omicron shots shows better immune response than original COVID vaccine
Moderna Inc said on Monday its Omicron-tailored vaccines produced a better immune response against the BA.4/5 subvariants in a mid-to-late stage study, when given as a booster dose, compared with its original shot. Data shows that both of Moderna's Omicron-tailored shots, mRNA-1273.214 and mRNA-1273.222, produced a higher antibody response against BA.4/5 subvariants than its original shot in vaccinated and boosted adults, the company said.
White House to ask for $10 billion in public health funds by year end -report
Officials from U.S. President Joe Biden's administration are finalizing a request this week for about $10 billion in public health funds by the end of the year, The Washington Post reported on Monday. This would be part of larger request in the lame-duck session of Congress that will include funding for Ukraine and disaster relief for hurricane damage in Florida, the article said.
U.S. FDA staff flags unclear benefits of Ardelyx's kidney disease drug
U.S. Food and Drug Administration staff reviewers on Monday raised concerns over unclear benefits of Ardelyx Inc's drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval. The FDA's staff reviewers said, "the magnitude of treatment effect appears less than that observed with approved drugs," in briefing documents released on Monday.
Factbox-Roche's drug failure extends long list of Alzheimer's trial setbacks
Roche Holding AG reported on Monday that its Alzheimer's drug candidate, gantenerumab, did not meet main goals of studies, marking another setback for companies trying to find an effective treatment for the memory-robbing disease. The results come nearly two months after partners Eisai Co Ltd and Biogen Inc reported that their Alzheimer's disease drug, lecanemab, significantly slowed cognitive decline in a large trial.
Roche's Alzheimer's drug fails to meet goal in long awaited trial
Roche's Alzheimer's drug candidate could not be shown to slow dementia progression in two drug trials, leaving rivals Biogen and Eisai as leaders in a high-stakes race to launch a treatment for the memory-robbing disease. Roche said in a statement on Monday that twin studies known as Graduate 1 and 2 had not reached their main goal of showing that the drug gantenerumab could preserve abilities such as remembering, solving problems, orientation and personal care in patients suffering from early stages of Alzheimer's disease.
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