NAVLIN Daily NewsCheckout Today’s News
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”
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
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
Michigan Reps. Debbie Dingell (D) and John Moolenaar (R) introduced a bill to tighten U.S.-China biotech investment regulations, citing national security concerns. The Biotech Investment National Security Act of 2026 would require the Treasury to scrutinize cross-border collaborations, targeting licensing deals between Chinese and U.S. companiesThe bill urges strict oversight of U.S. investments in China’s biotech sector, requiring defense and intelligence coordination to assess risks and a report on national security impacts. Critics argued that the bill is unnecessary and suggested streamlining U.S. clinical trials to compete globallyLawmakers are split, with Moolenaar warning of risky collaborations, while others highlight benefits like cheaper Chinese assets that can be developed to meet FDA standards
Details of Spain’s newly approved Royal Decree regulating the evaluation of health technologies (ETS) have been published in the Official State GazetteAs reported earlier this week, the Council of Ministers has approved the framework, in a move the government says will modernize healthcare decision-making and align the country with new European Union rulesA subtle modification appears in Article 15.1. As reported earlier this week, in the Ministry of Health’s own press release, it stated: “The purpose of the regulation is to establish guidelines for evaluating health technologies when these analyses—which will be mandatory but not binding.” However, the final BOE text removes the term “mandatory” entirely and states only that evaluations are “non-binding” and not compulsory
In an interview with NAVLIN Daily, Shalabh Gupta, Founder and CEO of Unicycive Therapeutics, explained the most pressing considerations in the current U.S. biotech landscapeAccording to Dr. Gupta, companies should consider payer evidence generation in the earliest stages of drug development: “You can never be too early, but especially by the time you get into the clinic or start the clinical trials”Dr. Gupta also reminded developers to understand their products’ “overall commercial viability" because a best-in-class profile isn't always enough to succeed. Sometimes, he said, "it comes down to the payer mix"
650+
+99%
<24
4,000+
24x7
99.5%
