New & Notable
FDA launches gen AI Elsa to support clinical, regulatory tasks
The FDA is scaling up the rollout of Elsa, an in-house generative AI tool designed to assist with clinical protocol reviews, adverse event summaries and internal data tasks.
FDA ends GLP-1 compounding for semaglutide, tirzepatide
The FDA’s decision to end temporary compounding permissions for GLP-1 drugs like semaglutide and tirzepatide pushes patients into insurance and prescription challenges.
Moderna's COVID-19 vaccine mNEXSPIKE gains FDA approval
Moderna's next-gen COVID-19 vaccine, mNEXSPIKE, has FDA approval for adults 65+ and high-risk individuals aged 12–64, marking the first approval under revised vaccine guidelines.
FTC targets 200+ Orange Book patents to boost generic drug access
The FTC has issued warning letters to major pharmaceutical companies over more than 200 Orange Book patent listings linked to brand-name drugs that delay generic competition.
Insights
Insights is research conducted by and for TechTarget Xtelligent Healthcare. Our work aims to leverage Xtelligent’s diverse readership of healthcare professionals across various sectors of the industry to understand real-world challenges and identify effective solutions.
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A podcast for healthcare professionals seeking solutions to today's and tomorrow's top challenges. Hosted by the editors of Xtelligent Healthcare Media, this podcast series focuses on real-world use cases that are leading to tangible improvements in care quality, outcomes, and cost.
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Latest News
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RFK Jr. ends COVID-19 vaccines for children, pregnant people
Health Secretary RFK Jr. reverses COVID-19 vaccine recommendations for healthy children and pregnant individuals, sparking concern over vaccination guidance and patient confidence.
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FDA framework ends universal COVID-19 booster recommendation
An updated FDA COVID-19 vaccine policy ends universal boosters and requires clinical outcome trials for individuals aged between 6 months and 64 years without risk factors.
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Novo Nordisk CEO steps down amid increased competition
Novo Nordisk CEO Lars Fruergaard Jørgensen will step down as the company faces heightened competition and a declining share price.
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Systemic gaps hinder cell and gene therapy adoption, access
Over 200 cell and gene therapy treatments could be FDA-approved by 2030, but adoption could lag due to structural barriers, limited infrastructure and centralized access.
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FDA reviews oral GLP-1 semaglutide for obesity
Novo Nordisk is pursuing FDA approval for the first oral GLP-1 semaglutide, aiming to expand Wegovy's indication for chronic obesity and weight management.
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How GLP-1 drug patents worsen healthcare disparities
Patent extension strategies and high pricing of GLP-1 drugs reinforce patient access barriers, deepening health inequities while generating massive profits and shareholder returns.
Features
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Understanding pharmaceutical patent thickets, exclusivity
Pharmaceutical companies increasingly rely on dense patent thickets, including continuation patents, to delay competition, extend exclusivity and protect profits.
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How digital twins are reshaping clinical trials
As drug development costs soar and timelines tighten, AI digital twins help sponsors cut enrollment, speed timelines and improve trial design, while meeting regulatory standards.
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Biosimilars set to surge as biologic patents expire
As key biologics near loss of exclusivity in 2030, biosimilars are expected to deliver major savings and drive $120B in market opportunities across the U.S. healthcare system.
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How Trump's pharma tariffs disrupt drug supply chains
With Trump's tariffs and global retaliation looming, pharmaceutical companies face financial risk, regulatory hurdles and pressure to quickly localize drug supply chains.