July Global News
Industry news tidbits from around the world.
• In an attempt to stifle the spread of counterfeit drugs, Kenya has called upon intelligence units to catch counterfeiters through means similar to drug trafficking methods. Medical Services Minister Peter Anyang Nyongo said in a statement that his department plans to work with the National Security and Intelligence Services to improve surveillance methods and reduce the number of counterfeit drugs in Kenya, which, according to the country's National Quality Control Laboratories and the Pharmacy Poisons Board, make up about 30% of all drugs circulated throughout Kenya. Similarly, Rwanda is also looking at pharmacies across the country in an effort to determine the prevalence of counterfeit malaria drugs.
• A new World Trade Organization amendment may allow pharmaceutical companies to produce lower-cost generic antiretrovirals, malaria treatments, and other medicines for developing countries. Taiwan recently approved the first reading of the proposed amendment, which would facilitate the importation of cheaper, generic drugs to developing countries if they cannot manufacture the drugs themselves. Countries that have already approved the amendment are Australia, China, the European Union, Japan, South Korea, and the United States.
• Scientists in Germany and Russia are working in conjunction with researchers at the University of KwaZulu-Natal (Durban, South Africa) to create a database that could help shorten the diagnostic times of drug-resistant tuberculosis to a mere 48 hours.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
