New & Notable
FDA removes REMS for all autologous CAR T-cell immunotherapies
The FDA has ended the Risk Evaluation and Mitigation Strategies safety program for six approved BCMA- and CD19-directed autologous chimeric antigen receptor T-cell immunotherapies.
ACIP votes to remove thimerosal from flu vaccines
The CDC's newly restructured Advisory Committee on Immunization Practices (ACIP) votes to recommend against flu vaccines containing thimerosal.
Novo Nordisk ends Hims & Hers partnership over GLP-1 safety concerns
Wegovy maker ended its month-old telehealth partnership with Hims & Hers over alleged deceptive marketing of compounded GLP-1 drugs from overseas suppliers, citing safety risks.
Extensive patent strategies drive U.S. drug price disparities
Patent extensions for drugs like apixaban (Eliquis) and semaglutide could add $200B+ to U.S. costs and delay access to affordable alternatives, despite Medicare price negotiations.
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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Healthcare Strategies: A Podcast
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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.
Guests from leading provider, payer, government, and other organizations share their approaches to transforming healthcare in a meaningful and lasting way.
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Latest News
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FDA voucher program expedites high-need drug approvals
The FDA's new voucher program fast-tracks drug reviews to 1–2 months for therapies that address U.S. health crises, unmet needs or national security priorities.
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GLP-1 real-world weight loss falls short of trial results
GLP-1 drugs like semaglutide and tirzepatide deliver lower weight loss in real-world use than in clinical trials, due to early discontinuation, suboptimal dosing and access challenges.
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RFK Jr. names 8 new members to CDC vaccine advisory committee
RFK Jr. appoints eight new members to the CDC Advisory Committee on Immunization Practices, days after firing the panel's 17 sitting members.
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RFK Jr. removes all 17 members of vaccine advisory committee
HHS Secretary RFK Jr. removes all 17 CDC vaccine advisory panel members, sparking industry concerns over vaccine policy, patient access and public trust.
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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.
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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.
Features
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How oral GLP-1 drugs could disrupt the weight loss market
FDA-approved oral GLP-1 formulations for weight loss could disrupt the weight management market, outcompete injectables and reduce patient access barriers.
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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.