FDA Proposes Fee Cuts to Keep Early Trials in the U.S., Adds Penalties for Overseas Development
Summary:
In early PDUFA VI reauthorization talks, the FDA proposed lowering user fees for companies running phase 1 trials in the U.S. while imposing higher or additional annual fees on developers conducting early-stage work abroad, aiming to incentivize domestic innovation amid rising concerns over America’s diminishing biotech competitiveness. The proposal emerges during a period of leadership instability and industry frustration over regulatory unpredictability, with biopharma leaders warning that added volatility and delays could push investment – and clinical development – outside the United States.
Protego Advances Novel Protein-Stabilizing Therapy for AL Amyloidosis with $130M Series B
Summary:
Protego Biopharma has secured $130 million to advance PROT-001, a first-in-class drug that aims to stabilize misfolded light-chain proteins in AL amyloidosis—an approach that could modify the disease rather than just treat symptoms and may extend to other protein-misfolding conditions. Backed by data gaps left by failed amyloid-clearing drugs, the company believes early stabilization could deliver deeper, faster, and more durable responses than current regimens like Darzalex, with late-stage trials planned for 2026.
FDA Moves to Curb Primate Testing for Monospecific Antibodies in New Draft Guidance
Summary:
The FDA has issued draft guidance recommending that developers of monospecific monoclonal antibodies no longer conduct six-month primate toxicity studies, instead relying on shorter three-month studies – or in some cases skipping them – when supported by existing data from similar antibodies and early toxicology findings. Framed as part of a broader shift toward non-animal testing and NAMs, the policy could reduce costs, timelines, and primate use, though some research groups caution that current data gaps in areas like HIV, rare cancers, and autoimmune diseases still necessitate animal studies.
Pharvaris’ Deucrictibant Delivers Fast Phase 3 Relief, Positioning to Challenge KalVista in HAE
Summary:
Pharvaris’ oral bradykinin B2 receptor antagonist deucrictibant achieved rapid symptom relief in a phase 3 HAE trial – 1.28 hours versus more than 12 hours on placebo – meeting primary endpoints and aligning with analyst expectations as the company prepares for a 2026 regulatory filing. With strong safety, high attack-resolution rates, and potentially faster full attack resolution than KalVista’s Ekterly, the data suggest deucrictibant could emerge as a highly competitive on-demand therapy in the HAE market.
UK/EU Regulatory Shifts and AI Adoption Set the CRO Agenda for 2026
Summary:
CROs are preparing for major regulatory updates – most notably the UK’s 2026 clinical trial rules and the forthcoming EU Biotech Act – while accelerating adoption of AI/ML and updating processes for the new ICH GCP E6(R3) standards to stay competitive against rising clinical activity in China and Australia. At the same time, data protection and privacy remain core priorities as global trials expand, with CROs strengthening cross-border data governance amid increasing customer expectations for sustainability and digital innovation.
