The European Parliament’s Public Health Committee approved the Critical Medicines Act on July 14. Initially, this measure was designed to decrease reliance on foreign generic drug manufacturers’ products, address drug supply shortages and keep treatments affordable across Europe.

Up to this point in the multi-year process, Bayer and Roche have been asking the EU to slow down and first complete a proper impact assessment. Their position is unsurprising, especially if one considers that generics and biosimilars make up 70% of dispensed medicines and 10-20% of the total drug bill in Europe. The impact of the EU’s Critical Medicines Act could become quite significant indeed.

Yet, EU lawmakers cited geopolitical pressures and global health security concerns as reasons to move faster. Their approved text comprises several new legislative instruments, including:

• “Buy European” – a drug procurement scoring system that factors in where a medicine and its active ingredients are made, not just its price.
• “Strategic projects” status – a fast-track permit and EU/national funding access process, available for companies wanting to build or upgrade manufacturing sites in Europe in exchange for priority supply guarantees.
• “Collaborative procurement” for any block of five countries or more – a way to potentially boost individual countries’ pricing and supply negotiation power by jointly buying critical medicines.

Yet the jury — as to the likely impact of these measures on medicines pricing and access — is still out.

Sandoz CEO Richard Saynor responded, saying that “reshoring all of Europe’s supply chains is a great aspiration, but is also completely unrealistic.” He argued the proposed changes will only work if production in Europe is economically viable; if not, drug prices will inevitably increase. The Parliamentary plenary vote is scheduled for November 23. Will others weigh in before then?

– Francesca Boldrini and Marie Montant, Real Chemistry

Health plans are facing a coordinated squeeze from Washington with pressure arriving from Congress, CMS and federal regulators.

The sharpest attention is coming from the Senate. Sens. Richard Blumenthal, D-Conn., and Josh Hawley, R-Mo., sent letters to UnitedHealthcare, Humana and CVS Health seeking answers on AI-driven prior authorization denials in Medicare Advantage. Their inquiry follows data showing MA plans deny post-acute care requests at notably high rates — 65% for long-term care hospitals and 54% for inpatient rehab — compared with less than 8% across all services. The fact that many denials are later reversed on appeal has made the issue an obvious target for lawmakers.

Legislation is already moving to capitalize on that momentum. The bipartisan Medicare Advantage Improvement Act of 2026 would require 72-hour standard authorization timelines, bar retroactive coverage denials and prohibit automated denial algorithms. Its path is uncertain, but the message to plans is clear: practices once treated as routine benefit design are now being read as patient access failures.

At the same time, CMS is adding pressure from a different direction: the proposed 2027 Physician Fee Schedule rule would cut the conversion factor for most physicians by roughly 1.68% and phase out MIPS by 2029 in favor of MIPS Value Pathways (MVPs). For plans with large ACO footprints, expanded shared savings tracks and simplified participation requirements are worth watching as CMS nudges providers toward two-sided risk.

CVS is trying to get ahead of the narrative. The company has been promoting Health100, an AI-enabled platform built with Google Cloud to help members navigate benefits, find lower-cost drugs and manage care. But that pitch now sits alongside a new FTC settlement finalized this week in which CVS Caremark agreed to several new terms, such as counting TrumpRx purchases toward deductibles and allowing clients to opt out of rebate models. CVS can argue it is adapting; regulators can argue they forced the issue.

Taken together, the three threads point to the same shift: benefit-design decisions once treated as internal and technical are now being judged by how they land on enrollees. For plans, the task ahead is less about explaining how the system works than proving that it works for the people in it.

– Leslie Isenegger, Head of Growth & Strategy, RC Resolve

Very few FDA approvals get The New York Times breaking news alerts – typically vaccines or treatments for previously untreatable severe diseases. But with heart disease as the #1 cause of death across the globe, subscribers woke up Thursday to an alert that Merck’s Lipfendra had received FDA approved as a category-changing medicine to lower bad cholesterol.

Lipfendra is the fourth PCSK9 inhibitor to be approved but enters the category as the first daily-pill option. The injectable market has long struggled with access and affordability challenges, prompting Amgen and Sanofi to reduce list prices by 60% in 2019 for Repatha and Praluent, respectively. Merck will launch Lipfendra at a list price of $10.50 per day, or approximately $315 per month — significantly below the annual list prices historically associated with injectable PCSK9 therapies.

The approval is also notable for another reason: Lipfendra is the ninth product reviewed and approved through the Commissioner’s National Priority Review Voucher program, an FDA pilot program intended to accelerate review of therapies deemed to advance important public health priorities. Lipfendra is also expected to be available at an undisclosed but discounted cash price on TrumpRx.

– Megan Hickey, Managing Director

This week, two of the Trump administration’s nominations for prominent HHS leadership positions faced an often-contentious nomination hearing before the Senate HELP Committee.

Outgoing Committee Chair Sen. Bill Cassidy, R-La, did not mince words during his questioning of Dr. Erica Schwartz, the nominee for CDC Director: “We need a CDC director that will actually stand up to crazy, stupid things being said that undermine faith in immunization.”

Schwartz, who the administration has reportedly deemed a “non-controversial pick,” has built a career of civil service across her time in the Coast Guard, U.S. Public Health Service, and as Deputy Surgeon General under the prior Trump presidency. During her remarks, she committed to “never betray the science” and “always have the public’s health in mind.”

But many Senators didn’t seem convinced. Schwartz was non-committal when asked whether she would report attempts to implement unscientific or harmful policies, saying instead that she did not believe the president or HHS secretary would ever ask her to do so. Committee members were quick to remind Schwartz of former CDC Director Susan Monarez’s prior accounts of political interference.

Another nominee, aspiring Assistant Secretary for Preparedness and Response Sean Kaufman also drew the ire of the committee, particularly around his past comments regarding hepatitis B, COVID-19 immunization and mRNA vaccine research. During a heated exchange, Sen. Cassidy confronted Kaufman about his previous social media post linking hepatitis B vaccination and autism, asking, “Why would you repeat these lies?” while slamming his fist down.

The jury is still out on whether Schwartz and Kaufman did enough to win the votes of skeptical Senators. The committee is scheduled to meet next week to vote on advancing the noms. If even one Republican Senator votes no, their nominations will fail to move forward and the persistent vacancies across HHS leadership will remain.

– Rachel Bridges, Senior Director

• July 22 – committee markup of 13 healthcare bills, Senate HELP
• July 23 – committee vote on the nomination of Erica Schwartz as CDC director, Senate HELP

• “There’s an increasing realization among business and political leaders how vulnerable some of Europe’s critical supply chains have become…When we talk to governments and figures in the industry, everyone gets it. No one will dispute it. The challenge is how we translate that into action.” – Richard Saynor, Fortune
• “The American share of early drug-development programs fell from about 48% in 2015 to 37% in 2024, China’s share rose from 8% to more than 32%.” – Don Loren, The Washington Times
• “Insurers like UnitedHealth or Cigna don’t just sell coverage. They’ve consolidated power over virtually every part of our healthcare system, operating hospitals, clinics and pharmacy networks. And they use that control to generate billions in profits…” – Howard Dean, Salon

• Marking our 25th anniversary, Real Chemistry announced the launch of ANATOMI, an ecosystem of AI solutions purpose-built to power the full healthcare commercialization lifecycle. Fierce Pharma: Real Chemistry builds body of AI healthcare commercialization tools with Anatomi launch.
• France is among several countries negotiating with U.S. trade officials to avoid potential investigations, although EU leaders warn that this could undermine current trade agreements. Politico: France, others in talks with US to avoid trade probes into pharmaceutical pricing.
• HRSA reported that 340B program purchases topped $100 billion in 2025, about a 23% increase from last year. STAT: Sales from controversial U.S. drug discount program rose to $100 billion last year.
• PhRMA and BIO are pushing back against an overhaul of federal grantmaking, warning that scaling back peer review could destabilize research funding and slow development of new therapies. BioCentury: BIO calls for withdrawal of OMB grant rule, PhRMA wants changes.
• Industry groups warn that Germany’s planned increase in drug rebates fails to address underlying challenges and could discourage pharmaceutical investment. Pink Sheet: Pharma Industry Slams New Health Reforms In Germany That ‘Undermine’ Innovation And Investment.
• FDA Acting Commissioner Kyle Diamantas has clarified that journal articles published by former Commissioner Marty Makary should not be considered official policy of the agency. Regulatory Focus: Diamantas backtracks on Makary’s policies issued in journal articles.
• Q2 2026 earnings season kicked off in healthcare with disclosures from Johnson & Johnson and UnitedHealth Group. BioSpace: Q2 earnings arrive as pharma picks up steam, buoyed by dealmaking, policy tailwinds.
• Researchers project that one model for U.S. most favored nation drug pricing  could lead to billions in potential savings. MedPage Today: Medicaid Could Save $$ Under ‘Most Favored Nation’ Pricing, Study Finds.
• The prediction market platform Kalshi will allow users to bet on clinical trial outcomes and FDA regulatory reviews in collaboration with AppliedXL, a group that monitors trials. Reuters: Kalshi to allow bets on clinical trials, FDA decisions.