WORLD HEALTH ORGANIZATION
🇪🇬Egypt
Nigerian Firm Codix Bio Secures First WHO-Backed License to Manufacture Rapid Diagnostic Tests in Africa
• Codix Bio has become the first company to receive a sublicense under WHO's Health Technology Access Programme, allowing it to produce rapid diagnostic tests using South Korean SD Biosensor's technology.
• The landmark agreement initially focuses on HIV testing with potential expansion to malaria and syphilis diagnostics, addressing Africa's critical dependence on imported medical products highlighted during the COVID-19 pandemic.
• The rapid diagnostic tests can deliver results within 20 minutes without sophisticated equipment, supporting WHO's 2023 World Health Assembly commitments to promote equitable access to diagnostics as a cornerstone of universal health coverage.
India's CDSCO Releases Draft Guidelines for Biosimilars Approval with Focus on Advanced Analytical Methods
• India's Central Drugs Standard Control Organisation has released draft revised guidelines for biosimilar approval, aligning with international standards and emphasizing advanced analytical methods over non-clinical studies.
• The 2025 guidelines update the 2016 version with strengthened requirements for analytical similarity, in vitro studies, and statistical considerations while reducing reliance on animal testing through 3Rs principles.
• Stakeholders have a 30-day window to submit comments to CDSCO, after which the guidelines will be finalized with minimal scope for further modifications.
EMA Suspends Valneva's IXCHIQ Chikungunya Vaccine for Elderly Following Safety Concerns
• European Medicines Agency has suspended the use of Valneva's IXCHIQ chikungunya vaccine in people over 65 years old following reports of 17 serious adverse events, including two deaths, in elderly patients.
• The suspension is temporary while authorities review safety data, with EMA maintaining current recommendations for IXCHIQ use in people aged 12 to 64 years, affecting over 40,000 doses administered worldwide.
• Similar precautionary measures were previously implemented in the United States and France, with Valneva's Chief Medical Officer pledging full cooperation with health authorities while exploring potential updates to the product's indication.
Bulevirtide Shows Durable Response in Chronic Hepatitis Delta Virus After Treatment Cessation
• Final data from Gilead's Phase 3 MYR301 study reveals 36% of chronic HDV patients maintained virologic suppression for nearly two years after stopping bulevirtide treatment.
• Notably, 90% of patients who achieved undetectable HDV RNA for ≥96 weeks during treatment remained virus-free after discontinuation, with no relapses occurring in the second year of follow-up.
• The findings, presented at EASL Congress 2025, demonstrate bulevirtide's potential as the first effective monotherapy for chronic HDV that maintains benefits even after treatment ends.
WHO Approves "Naxtarubicin" as International Generic Name for Moleculin's Cancer Drug Annamycin
• Moleculin Biotech's next-generation anthracycline Annamycin receives WHO approval for the international non-proprietary name "naxtarubicin," marking a significant milestone in its development and potential commercialization.
• The drug, designed to avoid multidrug resistance and eliminate cardiotoxicity common with current anthracyclines, is currently in a pivotal Phase 3 MIRACLE trial for relapsed or refractory acute myeloid leukemia with data expected in H2 2025.
• Moleculin has strengthened Annamycin's intellectual property portfolio with two new U.S. patents extending protection until June 2040, bolstering the company's position as it advances this potential treatment for hard-to-treat cancers.
PL BioScience Develops World's First Artificial Human Platelet Lysate for Cell Culture Applications
• German biotech PL BioScience has created the first-ever artificial Human Platelet Lysate (HPL), a breakthrough cell culture supplement produced from lab-grown platelets in partnership with Korean company DewCell Biotherapeutics.
• The artificial HPL provides a fully scalable, animal-free alternative to traditional Fetal Bovine Serum and donor-derived HPL, addressing critical supply limitations in cell therapy and regenerative medicine manufacturing.
• According to PL BioScience CEO Dr. Hatim Hemeda, the proprietary technology enhances cell performance compared to natural HPL while offering improved safety, consistency, and nearly unlimited supply potential for biopharmaceutical applications.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
Utah Becomes First State to Ban Fluoride in Public Water Systems
• Utah has made history as the first U.S. state to ban community water fluoridation after Governor Spencer Cox signed legislation that will take effect on May 7, 2025.
• The controversial ban comes amid debates over fluoride's safety, with supporters citing individual choice while dental experts warn it could increase cavity rates, especially in low-income communities.
• Research indicates fluoridation reduces cavities by approximately 27-30% in adults and children, raising concerns that the ban may lead to worsening oral health outcomes across the state.
Pfizer-BioNTech Launches Landmark Phase 3 Trial for mRNA-Based Influenza Vaccine
• Pfizer and BioNTech have initiated a 25,000-participant Phase 3 trial for their mRNA-based quadrivalent seasonal influenza vaccine, marking the first such advanced trial in the field.
• The novel vaccine targets four WHO-predicted flu strains for the 2022/23 northern hemisphere season, potentially offering advantages in production speed and efficacy over traditional vaccines.
• Current seasonal flu vaccines typically achieve 40-60% efficacy, while causing 290,000-650,000 respiratory deaths globally annually, highlighting the significant need for improved vaccination options.
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