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Thomas' Biotech Briefing
FDA clears 23 new drugs despite staffing cuts, while the UK MHRA warns companies on AI-generated inspection responses and AMO Pharma advances AMO-02 trial plans.
The top 10 stories from Mon Jul 6, 2026 06:57 AM to Tue Jul 7, 2026 06:58 AM
Generated July 7, 2026 at 6:58 AM
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#1 Generic And Biosimilar Industry: Let Us Into US FDA National Priority Voucher Program Published 2026-07-06 Only 12 of 118 biologic drugs expected to lose patent protection by 2034 have biosimilars currently in development. Covered by: insights.citeline.com |
#2 UK MHRA Flags Rejection Risk For Inadequate, ‘Overly Verbose’ AI-Generated Inspection Responses Published 2026-07-06 The UK MHRA says companies remain responsible for verifying the accuracy of information submitted using AI, warning that inadequate or overly verbose AI-generated inspection responses may be rejected. Covered by: insights.citeline.com |
#3 STAT+: GOP lawmakers push Trump’s FDA to make sure clinical trials are diverse Published 2026-07-06 Republican lawmakers are urging the Trump administration’s FDA to revise clinical trial policy to ensure trial participants resemble the patients who will use the resulting drugs and devices. Covered by: statnews.com |
#4 FDA approves 23 new drugs in first half, overcoming staff-cut concerns Published 2026-07-06 The FDA approved 23 new drugs in the first half of 2025, indicating drug-approval timelines have not yet been significantly slowed despite April 2025 staff cuts. Covered by: endpoints.news |
#5 Inside AbbVie’s Biology-First ADC Strategy Published 2026-07-07 AbbVie is building a large oncology antibody-drug conjugate pipeline and pursuing a strategy focused on matching treatments to patient biology. Covered by: insights.citeline.com |
#6 US FDA Readies Hemp Products Rule With Tighter THC Limits Imposed By Congress Approaching Published 2026-07-07 The FDA says its current enforcement discretion for hemp-containing supplements would not apply if Congress-imposed tighter THC limits take effect in November, making products unlawful for banks and insurers. Covered by: insights.citeline.com |
#7 New sa‑mRNA and LNP Platform to Support Korea’s Hantavirus Vaccine Initiative Published 2026-07-07 Korea University’s Vaccine Innovation Center will lead a government-supported project to develop next-generation hantavirus vaccines using self-amplifying mRNA and LNP platforms. Covered by: genengnews.com |
#8 AMO Pharma Announces Update on Scientific Advice for Registrational Clinical Study of AMO-02 in Congenital Myotonic Dystrophy Type 1 Following Meetings with the U.S. Food and Drug Administration, the U.K. Medicines and Healthcare products Regulatory Agency and Health Canada Published 2026-07-06 AMO Pharma plans a registrational study for AMO-02 in congenital myotonic dystrophy type 1, using hospitalization as the primary endpoint and multiple functional assessments as secondary endpoints, following regulatory feedback. Covered by: prnewswire.com, prnewswire.com |
#9 Pipeline Watch: Eight Approvals And Fourteen Phase III Readouts Published 2026-07-06 Pipeline Watch reports a weekly snapshot of selected late-stage clinical trial events and approvals, including eight approvals and fourteen Phase III readouts announced by pharmaceutical and biotech companies. Covered by: insights.citeline.com |
#10 Aureka Releases OpenDDE, an Open-Source Drug Discovery Engine Designed to Accelerate AI-Driven Therapeutic Discovery Published 2026-07-07 Aureka announced the July 6, 2026 release of OpenDDE, an open-source drug discovery engine using an all-atom biomolecular foundation model with co-folding to support scalable therapeutic discovery. Covered by: prnewswire.com |
