European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
List view / Grid view
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s novel approval means that certain patients with HIV have more options for treatment.
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
Incorporating artificial intelligence (AI) into the MHRA’s regulatory processes could help the agency focus on key priorities such as innovation.
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
During Dame June Raine’s five-year tenure as Chief Executive, MHRA delivered regulation facilitating key innovations in gene therapy and the world’s first COVID vaccine.
A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
Here, Chrysi Sergaki from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, explores how innovators and regulators can navigate the challenges affecting the development and regulation of microbiome therapeutics to bring safe and efficacious therapies to patients as soon as possible.
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
The US FDA has approved Vertex’s Casgevy and bluebird bio’s Lyfgenia, for one-time treatment of sickle cell disease in patients 12 years and older.
Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.