Non-Opioid Painkillers, Psychedelics, & Merck Newsletter
- Here's a summary of the key takeaways from the provided STAT News article:
- * Major pharmaceutical companies (Otsuka, Johnson & Johnson, Lundbeck, and even cautious players like Novartis and Roche) are actively watching and perhaps eyeing acquisitions of companies like...
- * The FDA released draft guidance to accelerate the development of non-opioid treatments for chronic pain, aiming to reduce opioid reliance (currently affecting 1 in 5 US adults).
Pharma & Biotech News Roundup – September 11, 2025
Here’s a summary of the key takeaways from the provided STAT News article:
1. Psychedelic Treatments Gaining Pharma Interest:
* Major pharmaceutical companies (Otsuka, Johnson & Johnson, Lundbeck, and even cautious players like Novartis and Roche) are actively watching and perhaps eyeing acquisitions of companies like Compass pathways and Beckley Psytech.
* These companies are advancing through Phase 2 and 3 clinical trials, signaling a shift of psychedelics from “fringe science” to a legitimate pharmaceutical opportunity.
2.FDA prioritizing Non-opioid Pain Relief:
* The FDA released draft guidance to accelerate the development of non-opioid treatments for chronic pain, aiming to reduce opioid reliance (currently affecting 1 in 5 US adults).
* This guidance covers Phase 3 trial design,safety,and labeling,and is linked to the SUPPORT Act of 2018.
* The FDA recently approved Journavx (Vertex pharmaceuticals) as the first-in-class non-opioid for acute pain,and this move reflects a broader federal push for alternatives.
3. Scrutiny of Soon-Shiong’s Anktiva Claims:
* Billionaire Patrick Soon-Shiong’s claims regarding the success of ImmunityBio’s Anktiva (approved for bladder cancer) are being questioned.
* New Phase 2 data in lung cancer doesn’t fully support his bold survival claims, and commercial uptake of Anktiva has been weak.
* While Phase 3 trials could prove beneficial, the existing data is being described as overstated.
4. Tragedy in Gene Therapy Trial:
* A child participating in a gene therapy trial for STXBP1 encephalopathy (a rare neurological disorder) died shortly after receiving the experimental treatment.
* Capsida Biotherapeutics, the sponsoring company, is developing viral vectors for gene delivery to the brain.
* This is a setback for the field, highlighting the risks associated with experimental gene therapies.
Links to further reading:
* Psychedelics: https://www.statnews.com/2025/09/11/pharma-companies-investing-psychedelic-treatments/
* Soon-Shiong/Anktiva: https://www.statnews.com/2025/09/11/soon-shiong-immunitybio-cancer-trial-results/
* Adam Feuerstein’s Newsletter: https://www.statnews.com/signup/scorecard/
* FDA Guidance: https://www.fda.gov/news-events/press-announcements/fda-issues-new-guidance-expand-non-opioid-options-chronic-pain-curb-misuse