New & Notable
Report: Up to 60% of clinical trials don't survive their first year
Between 45% and 60% of new U.S. clinical trial sites shut down within one year, but trial volume and government funding can increase longevity, new research says.
How TrumpRx could affect PBMs, specialty pharmacies, biotech
TrumpRx's transparent cash pricing could disrupt PBM rebate models, specialty pharmacy contracts and biotech's commercialization approaches, depending on uptake, experts say.
Trump's 100% tariff on branded drug imports spares Big Pharma
Trump's 100% tariff on branded drug imports favors pharma giants building in America, leaving small companies without U.S. manufacturing sites or expansion plans vulnerable.
Blurring the line between GLP-1 compounders, counterfeiters
Weak regulatory oversight has allowed 503A compounding facilities to abuse customization rules, blurring the line between GLP-1 compounders and unregulated drug manufacturers.
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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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.
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CDC Director fired as FDA restricts COVID-19 vaccine use
CDC Director Susan Monarez was fired the same day the FDA rescinded emergency use authorizations for COVID-19 vaccines, restricting use for seniors and high-risk younger people.
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Lilly eyes FDA review after oral GLP-1 weight loss trial
Eli Lilly's daily oral GLP-1, orforglipron, led to weight loss and improved glycemic control in a Phase 3 trial, setting it up for FDA review and competition with oral Wegovy.
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FDA begins publishing daily adverse drug reports for drugs, biologics
The FDA has begun releasing daily FAERS adverse event reports for all prescription drugs and biologics, enhancing post-market surveillance for frequent product monitoring.
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U.S.-EU trade framework caps pharma tariffs on branded drugs at 15%
A new U.S.-EU trade framework caps pharma tariffs at 15% for branded pharmaceuticals and places generics and their ingredients under the "most-favored nation" rate system.
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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.
Features
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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.
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Using AI to identify, expose online drug counterfeiters
Pharmaceutical companies are leveraging AI's advanced detection and enforcement tools to combat the online counterfeit drug market, protecting brand integrity and consumer safety.
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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.