Moderna

Moderna announced the first participant dosed in the Nova 301 Trial, a Phase 3 study evaluating mRNA-1403, an investigational norovirus vaccine. The trial aims to enroll 25,000 participants globally to assess efficacy, safety, and immunogenicity, focusing on older adults at risk of severe outcomes.

GLP-1 drugs like Ozempic and Mounjaro are gaining attention as blockbuster drugs face patent cliffs. These drugs, initially for diabetes, now show significant weight loss, positioning them as next-gen treatments. Competition is fierce, with Novo Nordisk and Eli Lilly leading, but other companies like Amgen, Roche, Pfizer, and AstraZeneca are entering the market. Expanding the conditions these drugs treat could influence insurance coverage. The snack industry may need to innovate as GLP-1 drugs reduce processed food consumption. The patent cliff threatens big pharma, but Medicare negotiations and biologic drugs offer strategies. Innovations like pill-form obesity drugs and mRNA cancer treatments are on the horizon. Oncology and immunology remain dominant, but obesity is emerging as a significant driver. Stock picks include Roche, mRNA companies, and Pfizer.

Moderna was criticized by PMCPA for a paediatrician offering £1,500 to children via WhatsApp to participate in a clinical trial, breaching standards and discrediting the pharmaceutical industry. The offer violated clinical trial regulations prohibiting financial incentives for children.

U.S. restarts free COVID test program, offering 4 free tests per household via COVIDTests.gov. Tests detect current variants and are usable through year-end. Over 900 million tests have been distributed. At-home tests provide results in 30 minutes or less, applicable to vaccinated and unvaccinated individuals. Vaccines, including mRNA and Novavax options, are also available, targeting dominant strains.

GSK discontinued its HSV therapeutic vaccine, GSK3943104, after a Phase I/II trial failure, highlighting challenges in developing a vaccine for genital herpes. Moderna and BioNTech are now leading contenders with mRNA-based HSV vaccine candidates in development.

Moderna criticized by PMCPA after NHS paediatrician offered £1,500 to children via WhatsApp for a Covid-19 trial, breaching clinical trial regulations. Moderna clarified no participants received incorrect payments, only expense reimbursements. The trial, evaluating mRNA-1283, showed positive results against SARS-CoV-2 variants.

Vaccine manufacturing is critical for future pandemic preparedness, requiring global collaboration and optimized processes. Inequitable distribution of COVID-19 vaccines highlights the need for manufacturing in low- and middle-income countries. Challenges include diverse vaccine platforms and regional infrastructure differences, necessitating significant process optimization. Collaborative efforts like BioNTech/CEPI in Rwanda aim to address these issues.

U.S. government offers another round of free COVID tests by end of September, available at COVIDTests.gov. Over 900 million tests have been distributed. At-home tests provide results within 30 minutes. Vaccines, including strain-specific formulations, are also available.

UK-based Vicebio raised $100m in Series B funding led by TCGX to advance its RSV and hMPV vaccine VXB-241 to Phase I trials, utilizing its 'molecular clamp' technology for enhanced immune response.