USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
UK – NICE recommends Amryt’s Filsuvez for rare skin disorder
Around 670 people in England with epidermolysis bullosa will benefit from the treatment
The National Institute for Health and Care Excellence (NICE) has recommended Amryt...
USA – FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent...
USA – Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient...
Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in...
UK – NICE gives green light for MSD’s Keytruda
The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study
MSD has revealed that the National Institute for Health and...
Europe – EMA review of data on paternal exposure to valproate
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines.
The review...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – FDA drafts guidance on classification category for biosimilar supplements
The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its...
Europe – Revocation of authorisation for sickle cell disease medicine Adakveo
On 26 May 2023, EMA’s human medicines committee (CHMP) recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises)...
