Happy New Year!
2023 ended with major events: 1st Crisper therapy approved by regulators: MHRA 1st, FDA and EMA. Several transactions with significant valuations (e.g. Karuna $14.0 B, Cerevel $8.7 Bn).
Let’s see what 2024 will bring to all of us!
European Medicine Agency (EMA)
The next CHPM meeting is planned on the of week of 22 Feb 2024. Of note, the following product obtained the PRIME indication, meaning that clinical development will hopefully move full steam now:
RGX-121 in the treatment of of Mucopolysaccharidosis Type II
2 vaccines: ChAdOx1 MERS and Respiratory syncytial virus
If you are interested about the summary of previous CHMP meetings, send an email to [email protected] with in the title: CHMP, we will take care of it.
US Food and Drug Administration (FDA)
Only 1 week in 2024 and already one approval by the FDA: ZELSUVMI ( berdazimer / Ligand Pharma) was approved in the treatment of molluscum contagiosum (molluscum). The label covers adults and paediatric patients 1 YO and older. Ligand Pharma press release.
Safety Surveillance PRAC and FDA
Another quiet week at the FDA and EMA: no new safety alert published for drugs by The FDA, and the next PRAC meeting is planned starting today (08 Jan 2024).
New data
Few studies published data since the 01 January 2024:
Lydra Therapeutics published positive data of its modified release Risperidone (1 oral dose per week) in adults with schizophrenia and schizoaffective disorder.
Applied Therapeutics Announces positive topline results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy.
All these hot news came few days ahead of the JPM, how timely!
About Health Economia:
Health Economia is an advisory firm, providing LifeScience investors scientific and technical support. We help our customers to make informed decisions about the development of their assets and act essentially on the buy side. As your scientific back-office, to support you, we:
- Provide scientific assessment and advice during the due diligence or negotiations
- Review/define and implement the development strategy of each of your portfolio companies.
- Identify, monitor risks and remediation activities.
Health Economia experts, with 25+ years of experience in regulatory, pre-clinical, CMC and Clinical Development, will support your projects.
