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The EU Council has agreed its negotiating mandate on a directive designed to accelerate biotechnology innovation across the bloc, paving the way for talks with the European Parliament on the proposed European Biotech Act I directiveCyprus’ Health Minister Neophytos Charalambides, speaking on behalf of the Council presidency, said the agreement demonstrated Europe’s determination to remain competitive in a rapidly evolving global biotech landscapeOnce the European Parliament has established its position, the two institutions will enter into negotiations to agree on the final text
Last week, NAVLIN Daily brought you key market access developments from across the globe. Discussions at NAVLIN’s PPIC and the EU HTA & Evidence Strategy Forum focused on major trends shaping the healthcare landscape. Roche Chairman Severin Schwan criticized U.S. MFN pricing negotiations as "blackmail" amid tariff threats, while the European Commission published the first-ever JCA under the EU HTA Regulation for Ojemda NAVLIN Daily was on the ground at the World Orphan Drug Congress USA 2026 and PPIC Basel, where experts discussed rare disease access, global regulatory alignment, MFN pricing, AI, and the EU JCA, with the European Commission's first JCA report generating significant interest Eli Lilly and Boehringer Ingelheim announced major investment pullbacks in Germany, citing proposed healthcare reforms, while Novo Nordisk launched its obesity treatment Wegovy in the UAE
NAVLIN Daily is on the ground at World Orphan Drug Congress USA 2026, where Julian Polaris from Manatt highlighted upcoming Medicaid provisions under the One Big Beautiful Bill Act (OBBBA)The OBBBA significantly alters Medicaid by imposing eligibility constraints, including work and community engagement requirements for coverage. While “medically frail” individuals are exempt from this requirement, the CMS left it up to the states to interpret this exemptionEach state is likely to take a slightly different approach and will need to be separately monitored for developments. “It is a challenging time to be advocating for states to expand access,” said Polaris
Secret U.S.-Germany talks are underway to discuss a deal similar to the U.S.-U.K. agreement, which offers relief from U.S. tariffs in exchange for relaxed price limits on innovative drugsTop German officials have been negotiating with the U.S. for months, according to industry insiders. The Berlin-based U.S. embassy has even sent an official to London to learn negotiation strategies from the U.K. playbook, hoping to push Germany toward a favorable dealMeanwhile, big pharma is reacting to German cost-cutting policies, with Eli Lilly, Boehringer Ingelheim, and Pfizer slashing or reconsidering investments in Germany
NAVLIN Daily is on the ground at the World Orphan Drug Congress USA 2026, where experts discussed the latest regulatory updates with emphasis on requirements for confirmatory trialsCompanies must now explicitly address the potential for withdrawal when a confirmatory trial doesn’t pan out, because this possibility has happened, noted Brigid DeCoursey Bondoc, Partner, Morrison FoersterWhen asked if she anticipates any major litigation with the FDA around accelerated approval confirmatory trials and withdrawals, the legal expert answered, “While there is due process, even then, there is an opportunity to litigate against the agency after the decision is made. Is it arbitrary and capricious? Courts are a lot more willing to step in and replace the agency’s reasoning…But after you’ve been through a public hearing process, it might not be your best public-facing campaign”
In the rare disease space, U.S. commercial payers are increasingly reliant on utilization management, including patient eligibility limits and step therapy restrictionsNAVLIN Daily is on the ground at the World Orphan Drug Congress USA 2026, where James Chambers, Professor, Tufts Medical Center, observed, “More than half of drugs approved by the FDA are rare disease drugs, which is fantastic. Now there are therapeutic options, but health plans are increasingly imposing limits on them. This is an underappreciated trend”Chambers also affirmed that reauthorization criteria can be flawed: “We see very concerning differences in criteria for the same drug for the same disease. Plans require patients to respond differently. This must create havoc for patients and providers”
Last week, NAVLIN Daily brought you key market access developments from across the globe. The European Commission opened the third 2026 submission window for joint scientific consultations (JSC) under the EU HTA Regulation U.S. lawmakers introduced the Biotech Investment National Security Act of 2026, a proposal that would tighten oversight of U.S.-China biotech collaborations and investments on national security grounds Brazil approved new regulations that will allow CMED to impose stricter price controls on newly launched drugs and expand mandatory discounts in public procurement
Spain’s proposed Medicines and Health Products Law has entered a crucial stage of review, introducing reforms that could significantly reshape pharmaceutical pricing and National Health System (SNS) financingThe draft legislation, currently under examination by the Council of State before its expected submission to Parliament, contains substantial revisions compared with the version previously released for public consultationAccording to Diario Farma, which has seen the new draft, the most significant change is the abandonment of the previously proposed “selected prices” model. In its place, the Ministry has developed a new pricing architecture that combines public financing mechanisms, reference pricing and a novel dynamic pricing system
Novo Nordisk has launched Wegovy pill (semaglutide tablets) in the United Arab Emirates (UAE)"I am thrilled that the Wegovy pill is now available in the UAE," said Emil Kongshøj Larsen, Executive Vice President, International Operations, Novo NordiskA clinical trial (OASIS 4) showed that the once-daily 25 mg Wegovy pill delivered an average 17% weight loss, comparable to the injectable version. About 1 in 3 participants achieved a 20% or more weight loss
The Netherlands National Health Care Institute (ZIN) has advised the Minister of Health, Welfare and Sport (VWS) to place Novartis’s Itvisma (intrathecal onasemnogene abeparvovec) in the lock for expensive medicinesItvisma, indicated for patients aged two years and older with 5q spinal muscular atrophy, is expected to be priced at EUR 1.945 million per treatment, similar to ZolgensmaMedicines are placed in the lock if they meet either of two thresholds: an expected annual national cost of EUR 20 million or more for one or more new indications, or an annual per-patient cost of at least EUR 50,000 combined with a total annual cost of EUR 10 million or more
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