Each week we highlight five things affecting the life sciences industry. Here’s the latest.
German company announces positive results for a celiac disease trial
- Topas Therapeutics, a German biotech company, reported positive phase 2a results for its celiac disease candidate, showing a good safety profile and early signs of antigen-specific tolerogenic effects, according to Fierce Pharma.
- The drug is part of Topas’ broader immune-tolerance platform, which could have applications beyond celiac disease, with other assets in development targeting autoimmune and immune-mediated diseases.
AI becoming an integral part of drug development, but cannot fully replace human judgment
- BioSpace explores how artificial intelligence is transforming drug development across multiple stages, from identifying targets and designing drugs to improving clinical trials, regulatory processes and manufacturing.
- While it enhances efficiency and accelerates processes, human guidance and expertise are still needed to navigate the complexities of biology and drug development.
Competition continues to increase in the obesity treatment space
- A competitive race in the obesity drug market is intensifying as companies work on next-generation treatments. Several companies are racing to bring an oral obesity treatment to a market that is currently only served by injectable drugs, per BioPharma Dive.
- Companies are also exploring innovations like muscle-preserving drugs and new obesity drug targets, such as CB1 inhibition. Several drugs are in different phases of clinical trials, with results expected in the coming months.
FDA and Health Canada present on regulation of AI-enabled devices
- Regulators from the Food and Drug Administration and Health Canada discussed the challenges of regulating AI-enabled medical devices at a conference this week in Toronto. The agencies spoke at length about monitoring algorithms that evolve over time and managing generative AI tools. Both agencies are focusing on life cycle management and performance monitoring, with the FDA planning new guidelines for AI-enabled devices in 2025, MedTech Dive reports.
- Current regulations require FDA-approved AI devices to have locked algorithms, but a new policy allows for certain pre-specified changes through predetermined change control plans. The U.S. and Canada are addressing issues such as bias, transparency and ensuring AI models work effectively in diverse populations.
Is an mRNA flu vaccine on the horizon?
- An innovative mRNA flu vaccine, now showing positive immune responses against both A and B strains of influenza in older adults, is addressing a key challenge that initially hindered its progress, Fierce Pharma reports.
- Following successful phase 2 results, the vaccine is now headed into phase 3 trials. If approved this would be the first influenza vaccine of its kind. Several companies have attempted to develop mRNA influenza vaccines but have run into roadblocks.
For more insights in life sciences, check out RSM’s industry outlook.
