WORLD HEALTH ORGANIZATION

Valneva SE submitted a label extension application to the FDA to potentially extend the use of its chikungunya vaccine IXCHIQ® to adolescents aged 12-17 years, including two-year antibody persistence data. This follows similar applications to the EMA and Health Canada. The applications are based on positive adolescent Phase 3 data showing a high and sustained immune response and good tolerability. IXCHIQ® is the world's first and only licensed chikungunya vaccine, currently approved for adults.

Anavex Life Sciences Corp. submitted blarcamesine (ANAVEX®2-73) MAA to EMA for Alzheimer's Disease treatment, showing clinically meaningful improvement over 48 weeks with a primary endpoint ADAS-Cog13 score >2 points, suggesting superior efficacy and neurodegeneration slowing in early AD patients. Blarcamesine, an oral small molecule, does not require routine MRI monitoring and has an appealing safety profile. Europe's Alzheimer's disease population is expected to double by 2030, with a 2019 care cost of $439 billion.

Anavex Life Sciences submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine, an oral Alzheimer's treatment showing 48-week ADAS-Cog13 score improvements >2 points, superior efficacy to existing therapies, and benefits like once-daily oral administration and no routine MRI monitoring.

A prospective cohort study enrolled 105 hospitalized and 73 non-hospitalized COVID-19 patients from April 2020 to April 2021, approved by Johns Hopkins University IRB. Non-hospitalized patients provided oral consent over the phone, while hospitalized patients gave written consent. Blood plasma samples were collected at various time points post-enrollment, with hospitalized patients' samples collected until death or 100 days post-enrollment. SARS-CoV-2 RNA levels were measured via RT-PCR, and SARS-CoV-2 variant inference was based on sample collection dates. Plasma proinflammatory cytokines and chemokines were measured using a custom multiplex kit, and binding antibodies were determined via ELISA. ACE2 binding inhibition and complement activation assays were also performed. ADCC assays and flow cytometry confirmed spike surface expression. Multiplex antibody assays on mucosal samples determined IgG and sIgA responses. Statistical analyses included linear regression, ANOVA, Spearman correlation, and linear mixed-effects modeling. Random forest modeling assessed predictive power of sociodemographic and serological variables for intubation or death outcomes.

Enveric Biosciences' preclinical PK studies of EB-003 show oral bioavailability, brain penetration, and no hallucination-like behavior in rats and dogs, supporting its potential as a non-hallucinogenic neuroplastogen for mental health disorders.

Nagaland’s doctor-population ratio of 1:4,056 exceeds WHO and India’s benchmarks, highlighted at NIDA conference. Dr Sukhato A Sema, MLA, advocates for equitable distribution of medical personnel, revisions to service rules and pay scales, and integration of private practitioners to curb brain drain. NIDA’s new executive members were introduced.

Anavex Life Sciences announced acceptance of a peer-reviewed manuscript detailing Phase IIb/III trial results of oral blarcamesine for early Alzheimer's disease treatment, to be published in an Alzheimer's-focused medical journal around Q4 2024/Q1 2025, and regulatory submission to the European Medicines Agency (EMA) in Q4 2024.

Merck's Phase 3 ZENITH trial of WINREVAIR met primary endpoint, showing significant reduction in PAH patients' morbidity/mortality risk. Trial stopped early due to efficacy, offering WINREVAIR in SOTERIA extension. Already approved in U.S. and 36 countries.

Eflornithine + lomustine combo shows clinically meaningful OS & PFS improvements in grade 3 IDH mutant astrocytoma patients, per Orbus Therapeutics' Phase 3 STELLAR study.

The anti-aging drugs market is projected to grow from $53.76 billion in 2023 to $77.85 billion in 2028, driven by aging populations, product innovations like SkinCeuticals' A.G.E Interrupter Advanced, and emerging technologies such as senolytic drugs and gene therapy.