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Search resuls for: "Human Medicines"


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The United Kingdom on Wednesday indefinitely banned new prescriptions of puberty blockers to treat minors for gender dysphoria. The announcement comes a week after the U.S. Supreme Court heard oral arguments in a case involving state bans on puberty-suppressing medication and other forms of transition-related care for minors. Puberty blockers are commonly prescribed to transgender children in countries throughout the Western world to delay the onset of puberty or pause it as it is transpiring. A temporary ban on new puberty-blocker prescriptions for British minors experiencing gender dysphoria was already put in place over the summer. The U.K. ban comes as the U.S. Supreme Court weighs the constitutionality of a Tennessee ban on gender-affirming care for minors.
Persons: Wes Streeting, Dr, Hilary Cass, Cass, , ” Iris Duane, Organizations: U.S, Supreme, England’s National Health Service, Health, Social, Human Medicines, Labour, Britain’s Locations: Kingdom, Britain, Tennessee, U.S
European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai , creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. But it almost always follows the drug regulator's recommendations. The European Medicines Agency's human medicines committee recommended against granting marketing authorization for Leqembi. Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In 2021, the European Medicines Agency rejected Aduhelm.
Persons: Eisai, Leqembi, Eli Lilly, Kisunla, Aduhelm Organizations: U.S, European Commission, U.S . Food, Drug Administration, Medicines, European Medicines Agency, Alzheimer's Locations: Biogen, U.S, Japan, South Korea, China, Israel, Europe, Alzheimer's Europe
Europe to decide on Novavax's COVID vaccine in October
  + stars: | 2023-09-21 | by ( ) www.reuters.com   time to read: +1 min
Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022. REUTERS/Frank Simon/File photo Acquire Licensing RightsSept 21 (Reuters) - The European Medicines Agency (EMA) expects to decide on the use of Novavax's (NVAX.O) updated COVID-19 vaccine in October, its director Emer Cooke said on Thursday. The agency had started the evaluation process for the protein-based shot on Aug. 24, Cooke said at a press conference. EU regulators recently gave the green light for an updated COVID-19 vaccine from Pfizer (PFE.N) and its German partner BioNTech (22UAy.DE), which targets the XBB.1.5 variant of Omicron. Moderna's (MRNA.O) updated shot is also on track to win approval.
Persons: Frank Simon, Emer Cooke, Cooke, BioNTech, Novavax, Bhanvi, Michael Erman, Saumyadeb Chakrabarty Organizations: REUTERS, European Medicines Agency, Pfizer, U.S . Food, Drug Administration, FDA, Moderna, Thomson Locations: Saabruecken, Germany, United States, Bengaluru, New York
Millions of people have viewed a BBC News interview with a British cardiologist who used the broadcast to spread misinformation about COVID-19 vaccines. Malhotra cites the British Heart Foundation (BHF) for reporting 30,000 excess cardiovascular deaths “during the pandemic or since the pandemic”. A BHF spokesperson told Reuters that there were indeed 30,000 excess deaths involving ischaemic heart disease (IHD) in England between March 2020 and August 2022. Reuters has addressed similar claims linking COVID-19 vaccines with excess mortality (here, here and here), cardiac arrests (here, here and here), and other heart issues. Experts say the 30,000 excess cardiovascular deaths reported since the beginning of the pandemic are due to COVID-19 infection and issues with healthcare services.
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