|
Thomas' Biotech Briefing
The FDA rejected ITM Isotope’s radiopharma therapy over manufacturing flaws, even as the agency advances an expedited IND pilot and tighter device reimbursement rules loom.
The top 10 stories from Tue Aug 11, 2026 07:04 AM to Wed Aug 12, 2026 06:55 AM
Generated August 12, 2026 at 6:55 AM
|
|
|
#1 Does China Reimburse Its Most Innovative Drugs? Published 2026-08-12 China’s basic medical insurance covers some of the country’s most innovative drugs, with solid tumors as the leading indication and Chinese companies dominating the covered products. Covered by: insights.citeline.com |
#2 Axing Self-Affirmed GRAS Pathway Without Notification Spurs Resource, Authority Questions Published 2026-08-12 The decision to eliminate the self-affirmed GRAS pathway without requiring notification has prompted questions about regulatory authority and resource implications. Covered by: insights.citeline.com |
#3 New Drug Application for LAE002 (afuresertib) Accepted by China's National Medical Products Administration Published 2026-08-12 Laekna (2105.HK) said China’s NMPA CDE accepted its NDA for LAE002 (afuresertib) for treating patients, with details of the indication not provided in the available text. Covered by: prnewswire.com |
#4 Why Patient-Focused Drug Development Should Drive Corporate Strategy Published 2026-08-11 The FDA issued patient-focused guidance outlining a framework for incorporating patient input into drug development, emphasizing how patient value can inform development decisions. Covered by: insights.citeline.com |
#5 Breakthrough Device Sponsors To Lose Key Payment Bridge As FDA And CMS Demands Climb Published 2026-08-11 An alternative NTAP reimbursement pathway’s payment bridge is expected to end after fiscal 2029, according to claims that FDA and CMS are tightening requirements. Covered by: insights.citeline.com |
#6 New EU Tool Helps Drug Developers Check If They Need A Joint Clinical Assessment Published 2026-08-11 The European Commission launched an online eligibility checker to help determine whether drug developers need a Joint Clinical Assessment. Covered by: insights.citeline.com |
#7 FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues Published 2026-08-11 ITM Isotope Technologies plans to resubmit its advanced cancer radiopharmaceutical therapy to the FDA after addressing the agency’s manufacturing-related concerns that led to rejection. Covered by: biospace.com |
#8 Scholar Rock rejigs approval filing after FDA flags violations at Novo plant Published 2026-08-11 The FDA classified the fill-finish facility as Official Action Indicated due to inspection findings, despite earlier claims of improvement, prompting Scholar Rock to adjust its approval filing. Covered by: biospace.com |
#9 With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development Published 2026-08-12 The article claims AI is increasingly used in drug development, including in pharma R&D and investment markets, to accelerate and reshape how new drugs are developed. Covered by: biospace.com |
#10 FDA moving fast on expedited IND pilot Published 2026-08-12 FDA is moving ahead with an expedited IND pilot, planning to select third-party reviewers by year-end and begin IND submissions next year. Covered by: biocentury.com |
