? Top themes this week: Alzheimer key developments, engineered cell therapy and CHMP meeting highlights
European Pharmaceutical Review
The leading FREE journal for all aspects of drug analysis, formulation, delivery, manufacturing and regulation.
? Alzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
We cover everything from market competition and promise of treatment potential to further clinical developments.
? FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
For the first time in over a decade, there is a new treatment option for patients with synovial sarcoma, a rare soft tissue cancer.?The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ??(afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease.
? CHMP meeting highlights – July 2024
In its July meeting, the EMA's human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
They concluded that considering the “observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi”.
?? Simplifying complex dosage forms with advanced encapsulation
Join our webinar on 4th September at 3:00PM BST to explore the benefits and challenges of developing multi-formulation combination capsules and learn from cases studies and use-cases to effectively resolve these challenges.
Key learning points include: