Second round of drug prices negotiated under the IRA revealed
The Trump administration’s Centers for Medicare and Medicaid Services (CMS) have announced the final prices for the second round of …
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Former FDA commissioners unite to condemn US vaccine proposals
A group of 12 former commissioners of the US Food and Drug Administration (FDA) have expressed concern about proposed changes …
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FDA appoints Tracy Beth Høeg as fifth CDER head this year
The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and …
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Formosa and Rxilient sign licensing agreement for APP13007
Formosa Pharmaceuticals and Rxilient Medical have signed an exclusive licensing agreement for the commercialisation of Byqlovi, clobetasol propionate ophthalmic suspension, …
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FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL
Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of …
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Richard Padzur to leave FDA following recent CDER leadership shift
After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center …
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Win for pharma in UK – zero US tariffs, VPAG rate cap and NICE threshold increase
On 1 December, the fortunes of the UK pharma sector changed radically, with the UK Government becoming the first in …
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AGC Biologics to expand cell line development with ATUM partnership
AGC Biologics is set to expand its Cell Line Development Centre of Excellence through a partnership with ATUM for integrating …
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Citizen Health and UCB collaborate for epilepsy drug development
Citizen Health has entered a multi-year strategic partnership with UCB for expediting drug development across five rare diseases and epilepsy. The …
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FDA steps back from preclinical primate testing amid wider regulatory shift
The US Food and Drug Administration (FDA) has taken another step away from animal testing – this time through draft …
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WHO backs use of GLP-1RAs for weight loss despite shortage warning
The World Health Organization (WHO) has endorsed the use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) for the treatment of obesity, …
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Regulatory factors in rare disease studies
The rare disease landscape poses myriad challenges for researchers, policymakers, and CROs, particularly in navigating its intricate regulatory environment. Rare …
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House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
The US House of Representatives has passed a new piece of legislation that reauthorises the US Food and Drug Administration’s …
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In a Honduran city, biotechs create gene therapy cocktails to fight aging
Próspera, a charter city on Roatán island in Honduras, hosts two biotechs working to combat ageing through gene therapy, as …
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Oncology trials: Delivering precision and reliability in data management
Clinical trials for oncology are filled with data management complexities that must be carefully navigated, with challenges and solutions outlined …
