viernes, 4 de septiembre de 2026

Editorial p867 Reimagining maternal cardiovascular health The Lancet (+...)

Editorial p867 Reimagining maternal cardiovascular health The Lancet https://www.thelancet.com/journals/lancet/issue/vol408no10558/PIIS0140-6736(26)X2033-5

Closing the preparedness gap: moving beyond emergency response to sustain the medical countermeasure ecosystem (+...)

https://www.thelancet.com/journals/lancet/onlinefirst

The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat

The 2025 small island developing states report of the Lancet Countdown on health and climate change: building resilience in the face of rising heat Georgiana M Gordon-Strachan, PhDa Send email to georgiana.gordonstrachan@uwi.edu ∙ Stephanie Y Parker, MSca ∙ Heather C Harewood, MDc ∙ Kimalie F Parchment, BSca ∙ David C Smith, PhDb ∙ Pablo Mendez-Lazaro, PhDe,f ∙ et al. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00106-3/fulltext?dgcid=raven_jbs_etoc_feature_langlo

The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study

The impact of the women’s medical education ban in Afghanistan on service coverage and maternal and neonatal mortality: a modelling study Shatha Elnakib, PhDa,b Send email to selnaki1@jhu.edu ∙ Timothy Roberton, DrPHc,d ∙ Husnia Sadat, MPHd ∙ Supriya Madhavan, PhDd ∙ Hadia Samaha, MAf ∙ Mohammad Mahdi Frough, MAe ∙ et al. https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00135-X/fulltext?dgcid=raven_jbs_etoc_feature_langlo

Small island developing states on the frontline The Lancet Global Health + +...

Small island developing states on the frontline The Lancet Global Health https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(26)00253-6/fulltext?dgcid=raven_jbs_etoc_email Sep 2026 Volume 14Number 9 https://www.thelancet.com/journals/langlo/issue/vol14no9/PIIS2214-109X(26)X2007-1

Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026

https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-modernizing-bioequivalence-approaches-topical-transdermal?utm_medium=email&utm_source=govdelivery Virtual Workshop Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products Thursday, September 10, 2026, 8:30 a.m. to 12:40 p.m. (EDT) Join via Adobe Connect: Advancing Generic Drug Development 2026: Modernizing Bioequivalence Approaches This virtual event is FREE! Are you developing a topical or transdermal generic drug product? Join this half-day virtual workshop to hear FDA experts discuss current regulatory recommendations, emerging bioequivalence approaches, and research that is helping streamline generic drug development and review. Attendees can ask questions and learn from case examples showing how GDUFA-funded research has informed guidance revisions and ANDA assessments. The workshop will also address characterization-based approaches, modeling and simulation, in vitro permeation testing (IVPT) method development, and recommendations for topical and transdermal delivery systems. https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/5118822171/event_registration.html?_charset_=utf-8&sco-id=7126601038&utm_medium=email&utm_source=govdelivery Topics Current recommendations, implementation challenges, and alternative bioequivalence approaches for topical products. Case examples showing how GDUFA-funded research has informed guidance revisions, reduced submission deficiencies, and supported ANDA assessments. How empirical and in silico research supports product-specific guidances and characterization-based bioequivalence approaches, including robust IVPT method development. Recommendations and implementation strategies for topical and transdermal delivery systems, including how to determine when in vivo studies such as sensitization studies are appropriate Audience Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and others who work on or have an interest in the development of topical and transdermal generic drug products.

Ionis wins FDA approval for first drug for Alexander disease, a rare and deadly neurological disorder Alexander disease is extraordinarily rare, so Ionis took an unusual approach to testing its drug

https://www.statnews.com/2026/09/03/ionis-fda-approval-zanvastro-alexander-disease/ By Jonathan WosenSept. 3, 2026 West Coast Biotech & Life Sciences Reporter