Drug Pricing
Revolution drug heralded as a pancreatic cancer breakthrough cleared by FDA
The U.S. FDA approved Revolution Medicines' pancreatic cancer drug Rasonque (daraxonrasib) on Wednesday for patients with metastatic pancreatic ductal adenocarcinoma who have received one prior treatment. In clinical trials, the drug nearly doubled median patient survival and has been hailed as a 'game-changing' therapy by oncologists and Wall Street analysts. Rasonque targets RAS mutations through a 'molecular glue' mechanism and is projected to reach peak annual sales of $11.5 billion.
Trump administration tries again to institute rebates in 340B
The U.S. Trump administration is again attempting to introduce a rebate mechanism into the 340B drug discount program. HRSA announced on Friday that, starting in 2027, some 340B discounts will be provided as rebates rather than upfront discounts. This is the second attempt after a pilot proposal earlier this year was invalidated following a court loss. Hospital groups have expressed opposition, with the American Hospital Association stating it is considering all available options to prevent the pilot program from taking effect.
Trump threatens tariffs on imported generic drugs
Trump posted on Truth Social, announcing a 100% tariff on imported generic drugs starting August 1, 2028, with the rate rising to 200% thereafter, to force companies to move production back to the US. However, policy details remain unclear, legal basis is questionable, and industry groups and analysts say further observation is needed.
Compounders maintain a firm grip on the GLP-1 market
A recent Gallup survey shows that the number of Americans using GLP-1 weight-loss drugs has grown nearly fourfold in two years, but about 20% of users still choose compounded versions not approved by the FDA. Despite pressure from Novo Nordisk and Eli Lilly through patent litigation and FDA regulation, the compounded drug market remains resilient.
CVS Caremark reaches settlement with FTC over insulin suit
Caremark, the pharmacy benefit manager under CVS Health, has reached a settlement with the U.S. Federal Trade Commission (FTC) over an insulin pricing lawsuit, agreeing to reform its business practices, including prioritizing lower-cost drugs on standard formularies, passing drug manufacturer discounts to clients, and adding provisions to prevent excluding independent pharmacies and third-party pharmacy hubs. The FTC estimates the settlement will save consumers approximately $8.5 billion over the next decade, with an additional $4.5 billion from point-of-sale rebate pass-throughs.
Express Scripts, PCMA sue to block Tennesee law breaking up PBMs and pharmacies
Express Scripts and a major pharmacy benefit management lobbying group separately filed lawsuits to block a Tennessee law that prohibits PBM-affiliated pharmacies from operating in the state. The lawsuits claim the law is unconstitutional and would force PBM-owned pharmacies to close, hindering access to prescription drugs for hundreds of thousands of patients. CVS's Caremark had already filed a lawsuit in May.
Medicare drug price rule may target under-the-skin Keytruda and Opdivo
CMS released a proposed rule on Friday aimed at closing the 'evergreening' loophole where drugmakers extend patent protection through formulation changes. The rule could bring subcutaneous versions of Merck's Keytruda and Bristol Myers Squibb's Opdivo into Medicare price negotiations for 2029 alongside their intravenous versions. However, new formulations may be exempt if intravenous biosimilars enter the market. Halozyme expects minimal impact on its royalty revenue from this rule.
Generic drugmakers gain key victory in ‘skinny label’ patent case
The U.S. Supreme Court ruled 9-0 on Thursday that Hikma Pharmaceuticals did not induce patent infringement in marketing a generic version of Vascepa, supporting the 'skinny label' practice. The ruling may raise the bar for challenging skinny labels, affecting the competitive landscape of the generic drug industry.
2026 Orphan Drugs Report: A safe(r) passage amid stormy waters?
Evaluate has released the "2026 Rare Disease Drug Report," noting that despite a turbulent regulatory and pricing environment, rare disease drug sales are steadily rising, expected to account for over 21% of global prescription drug sales by 2032, exceeding $400 billion. Policy tailwinds (such as IRA amendments and PRV program reauthorization) support growth, but the FDA has raised evidence standards for cell and gene therapies, and the share of FDA rare disease designations held by Chinese sponsors has risen from less than 5% in 2020 to 15% in 2025, intensifying competition. The pipeline value exceeds $100 billion, but the market share of rare disease drugs is expected to decline from a peak of 30% in 2027 to 22% by 2032.
Unlocking more value from mature drug products through strategic outsourcing
For a long time, pharmaceutical companies have managed mature brands only at a basic maintenance level. However, as the largest patent cliff in history approaches, the revenue share contributed by mature products is expected to continue rising. This article explores how strategic outsourcing of regulatory, safety, and quality functions can help pharmaceutical companies reduce operating costs, access scalable specialized capabilities, and revitalize the value of mature products.