Real-world studies show nirsevimab reduced RSV infant hospitalizations by up to 72% and maternal vaccination cut hospitalizations by nearly 70%, with benefits extending into the second RSV season.
Moderna posted a narrower-than-expected Q2 loss, with mFLUSIVA awaiting an FDA decision and a Phase 3 norovirus trial missing early success criteria. It reaffirmed 2026 revenue growth and cash guidance.
hVIVO has developed the first RSV B human challenge model to support next-generation vaccines. The model achieved ~90% infection rates and strong symptomatic disease, outperforming the established RSV A model. Challenge trials are increasingly accepted by regulators to accelerate vaccine development.
The European Medicines Agency is enforcing clinical trial transparency and has launched a new vaccine information initiative, while a coalition of health professionals warns of suboptimal vaccination coverage across Europe. An analysis also shows that only a portion of EMA-approved medicines are available to NHS patients in England after additional assessments.
Crispr Therapeutics AG trades at $47.78 with a $4.78B market cap, while Moderna trades at $61.82 with a $25.06B market cap, about 5.2 times larger. Both face losses, but CRISPR's Casgevy approval and Moderna's pipeline advances shape divergent analyst outlooks.
Tracy Beth Hoeg, the FDA's acting drug center director, has been removed from her role after leading reviews of antidepressants, COVID-19 vaccines and RSV drugs. She is replaced by Dr. Mike Davis, as the agency continues a leadership shake-up.
Tracy Beth Høeg said in her first address to staff that she will scrutinize antidepressants and RSV products used to protect babies. She said she is prioritizing the health of women and babies.
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.
NVIDIA and Eli Lilly announced a $1 billion AI co-innovation lab as AI drug discovery expands across research, trials and manufacturing. Companies including Recursion and Tempus are using large biological and clinical datasets to speed development and support precision medicine.
The FDA has expanded approval of GSK's Arexvy RSV vaccine to include adults aged 18 to 49 years at increased risk for lower respiratory tract disease, based on phase 3b trial data showing noninferior immune response.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07756528 |
Stakeholder-Informed RSV Prevention Economic Model in Botswana |
ACTIVE_NOT_RECRUITING | |
| NCT07713628 |
Immune Reponses to RSV B Challenge in Older Adults (A Controlled Human Infection Study With RSV in Older People-02) |
NOT_YET_RECRUITING | NA |
| NCT07700134 |
The Role of Vitamin D and Vitamin D Receptor in Recurrent Wheezing in Children With Bronchiolitis: Immunological Association With T-lymphocyte Mitochondrial Mass |
ACTIVE_NOT_RECRUITING | |
| NCT07508644 |
RSV Vaccination to Reduce Recurrent AECOPD |
NOT_YET_RECRUITING | PHASE4 |
| NCT07482657 |
A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus |
RECRUITING | PHASE2 |
| NCT07418229 |
Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine |
NOT_YET_RECRUITING | PHASE1 |
| NCT07321314 |
RSV Burden in Hong Kong |
NOT_YET_RECRUITING | |
| NCT07308158 |
Covid Flu A/B and RSV 4 in 1 Diagnostic Test |
COMPLETED | |
| NCT07217639 |
Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings |
NOT_YET_RECRUITING | NA |
| NCT07147517 |
Preparedness Through Respiratory Virus Epidemiology and Community Engagement |
RECRUITING |
