Health Agency

• The FDA has introduced a new fast-track program for the approval of biologics, including experimental gene therapies for conditions like sickle cell disease and cancer. • Traditionally, the agency requires a rigorous three-phase trial process involving healthy volunteers, dose-finding studies, and large-scale clinical trials to ensure safety. • Critics argue that these political shortcuts may undermine the FDA's international reputation and its standing as a global authority on drug safety.

Wyden says in a letter addressed to Robert F Kennedy Jr that HHS is preparing an ‘unprecedented legal framework’Ron Wyden, a US senator of Oregon, accused the Department of Health and Human Services (HHS) of preparing to use what he describes as an “unprecedented legal framework” to deport more than 500 unaccompanied migrant children currently in the custody of the agency’s Office of Refugee Resettlement (ORR).In a letter addressed to the HHS secretary, Robert F Kennedy Jr, Wyden said he had obtained “credible information” that the department was using a list of more than 500 children as targets for expedited removal under a new administrative process that he says lacks statutory authority. He called the reported initiative “deeply alarming” and urged HHS to immediately suspend any related screening or removal efforts. Continue reading...

• The US Administration is restructuring the systems supporting PEPFAR and global health security, shifting its engagement strategy toward regulatory influence over long-term public health partnerships. • Concerns are rising that increased political oversight and the deconstruction of international collaborations may undermine the NIH's scientific infrastructure and its history of HIV research and vaccine development. • In a move toward regulatory cooperation, the US Food and Drug Administration (FDA) and the African Medicines Agency (AMA) signed a Memorandum of Understanding (MoU) to establish a shared framework for information sharing.

• Northern Ireland’s Health Minister has praised a Public Health Agency warning regarding drug use, describing the guidance as "practical." • The statement comes amid legal proceedings where the Minister and his wife, Eleanor Donaldson of Dromore, Co Down, face criminal charges. • The Minister denies all allegations, while his wife is charged with aiding and abetting and has also denied the charges.

Students from Reading Blue Coat school, and Highdown secondary school and Sixth Form Centre receiving treatmentTwo schools attended by pupils receiving treatment for meningitis have been named amid an outbreak of the infection in Berkshire which has caused the death of a student.The patients attend Reading Blue Coat school and Highdown secondary school and Sixth Form Centre, according to the UK Health Security Agency. Their close contacts have been offered antibiotics as a precaution. Continue reading...

Advocates say Lee Zeldin’s EPA has rolled back protections and cut staff and funding, putting health at riskSign up for the Breaking News US email to get newsletter alerts in your inboxMore than 160 environmental and public health organizations on Tuesday called for Lee Zeldin, the Environmental Protection Agency (EPA) administrator, to resign or be fired.“No [EPA] administrator in history – Democratic or Republican – has so brazenly betrayed the agency’s core mission,” the groups wrote in an open letter. “EPA’s foremost purpose is to protect human health and the environment. With Administrator Lee Zeldin at the helm, EPA has abandoned its mission, creating damage that will take decades to address.” Continue reading...

UKHSA says on Monday morning there has been no change since 20 cases were confirmed on SundayThere have been no new cases of meningitis linked to an outbreak in Kent reported, the UK Health Security Agency (UKHSA) has said.As of 12.30pm on Sunday, 20 cases had been confirmed, with a further nine under investigation. This was no change on the previous day, the UKHSA said in a statement on Monday morning. Continue reading...