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Members of the Pharmaceutical Research and Manufacturers of America (PhRMA), including Pfizer CEO Albert Bourla, met with Japanese officials on Nov 18 to address Japan's drug pricing policies. They highlighted concerns over low initial drug prices, frequent price cuts, and the impact of the U.S.'s Most Favored Nation (MFN) pricing policy on Japan's pharmaceutical sectorAt the meeting, PhRMA called for reform of Japan’s system to ensure it does not continue to decline in competitiveness. Specifically, PhRMA urged the Japanese government to maintain drug prices during patent periods, limit price cuts, improve initial pricing for new drugs, and develop a national pharma innovation strategy for global competitivenessCompanies have already seen impacts on products in Japan due to MFN. All 10 companies recently surveyed by the Japanese arm of the European Federation of Pharmaceutical Industries and Associations (EFPIA) responded that they believe MFN will impact their global pricing strategy
Cell and gene therapies are booming but still face hurdles like regulatory complexity, as discussed at Advanced Therapies USA 2025. Experts advocated for a more flexible FDA review process, especially for rare conditions. Industry insiders highlighted significant progress despite the field’s early stageCompanies like Ocugen and Atara work through challenges like FDA applications and manufacturing issues, while regulators show openness to single-arm trials for rare pediatric therapies. Partnerships with pharma giants, like Bayer’s backing of AskBio, remain crucial for development and fundingLeaders see promise in the market’s growth but admit the broader industry needs to understand cell and gene therapies’ transformative potential. While advanced therapies like Roche’s Luxturna set precedents, each product demands unique strategies
Negotiators are entering the most sensitive stage of talks on the EU’s pharmaceutical legislative package, with a single issue now overshadowing all others, whether companies should be legally required to place medicines on the market in every Member State that requests them, under threat of sanctionsAfter months of technical drafting and two high-level political rounds with little movement, Diario Farma reports that sources familiar with the trilogues say the central dispute is no longer innovation incentives, data-protection periods or exclusivity vouchers for antibiotics. Instead, the deadlock hinges on a proposed obligation for manufacturers to launch products across the entire EU and ensure supply, a requirement that has split institutions and frozen progress across the wider reformEarlier this month, Adam Jarubas, Chair of the European Parliament’s Committee on Environment, Public Health and Food Safety (SANT), emphasized that the Danish Presidency seems “determined to reach an agreement by the end of this year. It will be difficult, but if the Presidency shows the necessary flexibility, it should still be possible”
The UK pharma industry and government have agreed to extend the deadline for companies to leave the 2024 Voluntary Scheme for Branded Medicines Pricing (VPAG) to 16 December 2025The extension supersedes both previous extensions agreed in September and OctoberCompanies that notify their departure before the new November deadline will not be able to reverse their decision. Those that do not submit notice must remain in the scheme throughout 2026. Any companies exiting VPAG will instead move onto the statutory scheme for branded medicines
The Centers for Medicare & Medicaid Services (CMS) has updated the Request for Applications (RFA) document for its recently announced GENEROUS drug pricing model, providing new details regarding its reference basket methodologyThe latest language included in the RFA clarifies that the benchmark used to calculate the Most Favored Nation (MFN) price for a COD will be the second lowest country-specific manufacturer-reported net price, adjusted by gross domestic product per capita using a purchasing power parity methodNAVLIN Daily will continue to monitor and report on any additional changes to the model as they develop
Industry leaders met yesterday at the FT Global Pharma and Biotech Summit in London to discuss dramatically changing policies on both sides of the Atlantic, from Europe’s new pharmaceutical strategy to the U.S.' Most Favored Nation (MFN) pricingWhile the room was packed out with senior industry representatives and payers who all harbor thoughts on these topics, those on stage kept their cards close to their chestsRead on to learn NAVLIN Daily’s learnings from the first day of the Summit
We’re back at the Financial Times’ (FT) Global Pharma and Biotech Summit in London for day two, where Dr Sam Roberts, Chief Executive Officer (CEO) of the National Institute for Health and Care Excellence (NICE), kicked off the day talking about NICE’s transformation journeyThe outgoing CEO, who will be leaving at the end of 2025, addressed the Agency’s closer collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), the premise of the Voluntary Pricing and Access Scheme (VPAG), and the controversy surrounding the Enhertu (trastuzumab deruxtecan) decision under NICE’s new severity modifierDr Roberts confirmed that the joint working pathway between NICE and the MHRA launched on 1 October, marking what she described as “20 years” of ambition finally realized. “We’ve got the first couple of medicines that are part of that pathway where we’re constantly sharing data with MHRA,” she said. “Our aim is to have NICE advice and MHRA license as close together as possible, ideally on the same day.”
Novo Nordisk has slashed the price of its weight-loss drug Wegovy (semaglutide) by up to 37% in India, according to a document seen by ReutersThe company’s highest dose of 2.4 mg will now cost ₹16,400 (approximately $186.59, at the time of publishing), down from ₹24,389.06 (approximately $277) previously. The lowest dose of 0.25 mg has been reduced to ₹10,850 (approximately $123), compared with ₹16,260.94 (approximately $185) previously, according to the document"We have made sure to listen to our patient and doctor communities and take active measures for the benefit of people at large," said Vikrant Shrotriya, Managing Director, Novo Nordisk India
Speaking at the Financial Times’ (FT) Global Pharma and Biotech Summit in London, Patrik Jonsson, Executive Vice President and President, Lilly International, told the crowd, "My understanding is that the [Voluntary Scheme for Branded Medicines Pricing (VPAG)] deadline has probably been postponed for another two weeks, so until the end of November at the earliest.”The deadline is scheduled for this coming Friday, November 14. There has been no public announcement that the VPAG has been delayed by another two weeks, so Jonsson’s remark is just speculation until verifiedCompanies that notify their departure before the new deadline will not be able to reverse their decision, and companies exiting VPAG will instead move onto the statutory scheme for branded medicines. The adjustments have been introduced to give companies additional time to weigh their options amid what the Association of the British Pharmaceutical Industry (ABPI) described as “ongoing global uncertainty.”
Last week, U.S. drug pricing policies continued to make headlines globally as the Centers for Medicare & Medicaid Services (CMS) announced a new voluntary model intended to implement MFN pricing through State Medicaid programs, and Novo Nordisk and Eli Lilly became the fourth and fifth drugmakers to sign MFN deals. If you’re interested in MFN, ask the team about our MFN Tracker or our new Policy Newsletter Across the pond in Europe, Joint Clinical Assessment (JCA was the hot topic at conferences and meetings; NAVLIN Daily attended the World Orphan Drug Congress (WODC) in Amsterdam and European Access Academy (EAA) in Paris, where stakeholders discussed the ups and downs of the first year of the Regulation Meanwhile, China wrapped up its National Reimbursement Drug List (NRDL) and new Commercial Insurance Innovative Drug List, slashing prices by 15-50%. This year is the first time that a separate Innovative List has been developed, and the outcomes will be closely watched
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