Also known as: EU
The WHO approved the first malaria drug for infants weighing under 5kg, and researchers unveiled a single-dose compound, cabamiquine, showing promise in early trials. Investment in the Medicines for Malaria Venture yielded $13 in health benefits per $1 invested, averting 1.6 million deaths.
Federal and international funders have announced life sciences and biotech funding opportunities: NIH awards up to $30 million, NSF fellowships, and roundups exceeding $900 million. Scholarships and grants are open worldwide, with AI and local eligibility as key criteria.
Unicycive Therapeutics received an FDA Complete Response Letter for its oxylanthanum carbonate NDA resubmission due to third-party manufacturing deficiencies. The FDA raised no efficacy or safety concerns and requested no new data. Labeling discussions are ongoing.
Mexico and Finland cut clinical trial approvals to 30 days; the EU Biotech Act proposes faster timelines and harmonized rules. Finland will also establish FinTrials to boost clinical research.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
Merck's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
The EU Critical Medicines Act enters trilogue negotiations as drug shortages persist. The Parliament proposes broader powers for a new coordination group, binding stockpiling, and expanded MEAT procurement criteria. EMA recorded 136 critical shortages from 2022-2024.
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07726537 |
Testing of Personal Protective Equipment (PPE) for First Responders |
RECRUITING | NA |
| NCT07659457 |
Functional Skills Training for Supermarket Shopping Using NFC Technology in People With Intellectual Disabilities |
COMPLETED | NA |
| NCT07622420 |
ProspectiveFemaleAYA - Late Effects of Cancer Therapies on Gonadal Function, Fertility, Efficiency of Fertility Preservation Procedures and Pregnancy Outcomes |
NOT_YET_RECRUITING | |
| NCT07617272 |
Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore |
RECRUITING | PHASE2 |
| NCT07498179 |
Activation-Socialization Intervention Program for Seniors |
ENROLLING_BY_INVITATION | NA |
| NCT07489365 |
Evaluability and Feasibility of the eHOOD Intervention |
COMPLETED | NA |
| NCT07464561 |
RESCCUE4 - Group CBT for Social Anxiety in Adolescents |
COMPLETED | NA |
| NCT07416513 |
Digital Solutions for bEtter cAre |
RECRUITING | NA |
| NCT07411001 |
Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC) |
ACTIVE_NOT_RECRUITING | NA |
| NCT07374887 |
Impact of Snoezelen Intervention and Reminiscence Therapy on Seniors' Emotionality and Anxiety |
COMPLETED | NA |
