New & Notable
Generic, biosimilar markets at risk despite saving $467B in 2024
Generics and biosimilars cut U.S. drug costs by $467B in 2024, but the AAM warns that PBMs, IRA rules and a lack of competition threaten long-term stability of the market.
What the FDA's DTC drug ad crackdown means for pharma companies
As the FDA and HHS rein in direct-to-consumer drug advertising, new compliance rules and AI-driven monitoring could require some pharma companies to rethink their marketing approach.
Will the FDA's green list end illegal GLP-1 compounding?
The FDA recently created a green list to regulate imported GLP-1 drug ingredients, yet experts say that weak enforcement could allow illegal compounding operations to continue.
Elsevier launches PharmaPendium AI to boost R&D, compliance
Elsevier debuts PharmaPendium AI, a GenAI tool that helps regulatory, preclinical and clinical teams access FDA, EMA and other regulatory data to accelerate R&D and compliance.
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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Novo's $499 self-pay Ozempic bypasses payers, curbs compounders
Novo Nordisk's $499 self-pay program bypasses traditional payers to provide direct access to FDA-approved Ozempic and curb the uptake of unapproved compounded versions.
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HHS restores defunct task force on childhood vaccine safety
HHS reinstates a defunct childhood vaccine safety task force following a lawsuit funded by Children's Health Defense, an anti-vaccine group previously led by HHS Secretary RFK Jr.
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Studies link GLP-1 use to T2D rare eye risks, urge screening
New research links GLP-1 use in type 2 diabetes to slightly higher risks of optic neuropathy and diabetic retinopathy, with study authors urging regular preventative eye exams.
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Trump's pharma import tariffs threaten drug pricing, generics
Trump's plan to raise pharma import tariffs up to 250% could drastically increase drug prices, eliminate access to affordable generics and limit R&D efforts across the industry.
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HHS ends $500M in BARDA‑funded mRNA vaccine developments
With no announced timeline, HHS moves to terminate all mRNA vaccine development funded by BARDA, impacting 22 projects worth roughly $500 million.
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FDA updates opioid pain medication labeling requirements
The FDA will soon require opioid makers to update safety labels to highlight the risks of addiction, misuse, overdose, high doses and long-term use.
Features
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Exploring Red No. 3 ban reformulation strategies for Rx, OTC drugs
By Jan. 15, 2028, drug makers must rethink their approach to excipients, stability and color strategy to remove Red No. 3 from ingested prescription and over-the-counter products.
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Understanding the importance of randomized clinical trials
Randomized controlled trials are the gold standard for proving therapeutic value, drug safety and efficacy, shaping pricing, reimbursement and securing regulatory approval.
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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.