Pharminent · Daily Brief
October 29, 2026
Regulatory & Approvals
FDA issues guidance framework for personalized gene therapies
The FDA unveiled guidance offering an approval framework for “plug and play” personalized gene therapies that benefit different subsets of patients with the same disease.
BioPharma Dive →
HHS announces enforcement holiday for unapproved peptide manufacturing
HHS unveiled an enforcement holiday covering the manufacture of unapproved peptides, ahead of an FDA decision on whether they should be allowed in compounded medicines.
Pharmaphorum →
Clinical Data
Lilly’s retatrutide beats Ozempic in phase 3 type 2 diabetes trial
Topline phase 3 results showed Lilly’s retatrutide beat Novo’s Ozempic on measures of blood sugar and weight loss in adults with type 2 diabetes. Retatrutide is a peptide designed to activate three metabolic targets, versus the single target hit by Ozempic.
MedCity News →$LLY$NVO
Lyme disease vaccine LB6V misses primary endpoint at IDWeek 2026
Data presented at IDWeek 2026 showed the prophylactic Lyme disease vaccine candidate LB6V missed its primary endpoint.
Pharmaceutical Technology →
Deals & Partnerships
Astellas pays $285M for option on Audax cancer immunotherapy
Astellas paid $285 million for an option on an IL-12 fusion protein cancer immunotherapy developed by Audax, in a deal worth up to $1.34 billion. Gilead and Teva also added to their pipelines.
Pharmaphorum →$GILD
Business & Finance
Lilly beats estimates, raises sales outlook on Zepbound and Mounjaro
Eli Lilly reported third-quarter results that beat estimates and raised its sales outlook, with sales of obesity drug Zepbound and diabetes treatment Mounjaro surging again in the quarter.
CNBC →$LLY
Merck tops quarterly estimates and raises profit outlook on Keytruda
Merck beat quarterly estimates and raised its profit outlook, with its immunotherapy Keytruda, including a newer injectable form, posting stronger-than-expected sales.
CNBC →$MRK
GSK shares fall on weaker third-quarter vaccine sales
GSK shares came under pressure after vaccine sales declined in the third quarter, while demand for its other drugs was strong.
Pharmaphorum →$GSK
Lilly to merge US and international divisions; Novartis writes down Avidity deal
Lilly intends to merge its U.S. and international divisions when a top executive retires, while Novartis wrote off part of its Avidity deal.
BioPharma Dive →$NVS$RNA$LLY
Formation Bio launches $600M fund to acquire stalled drugs
AI biotech Formation Bio launched a $600 million fund to buy or license drug candidates that have stalled, focusing on clinical trials rather than discovery.
Forbes →
Missouri attorney general warns Lilly over 340B claims data requirement
Missouri’s attorney general warned Eli Lilly to discontinue requiring hospitals to provide claims data in order to receive discounted medicines under the 340B program.
STAT →$LLY
Biopharma industry split over Treasury’s proposed China rule
The biopharma industry is divided over the impact of the Treasury Department’s proposed China rule, with an exemption for a common kind of biopharma deal at the heart of the disagreement.
STAT →
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