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In an official release, the European Commission announced that the first two joint clinical assessments (JCAs) for medicinal products had started under the Health Technology Assessment Regulation (EU 2021/2282), which took effect across Europe on January 12, 2025The first product targets pediatric cancer, while the second is an advanced therapy medicinal product (ATMP) intended to treat skin cancer.HTA bodies from Ireland, Germany, France, and Poland are conducting the assessments in parallel with the European Medicines Agency’s marketing authorization process, which began on March 27, 2025
President Trump signed an executive order directing the U.S. Department of Health and Human Services (HHS) and Congress to address the Inflation Reduction Act’s (IRA) so-called "pill penalty." Specifically, the order directs officials to "align the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries"The wide-ranging order directs HHS and other agencies to carry out several additional actions related to drug pricing, including calling on officials to investigate and "reevaluate" the role of pharmacy benefit managers (PBM), take steps to streamline prescription drug importation programs, and provide recommendations to reduce anti-competitive behavior from pharmaceutical manufacturersAlthough most of the order will require additional rulemaking or legislation to have any effect, it represents the first concrete steps the second Trump administration has taken to address prescription drug prices
Natco Pharma plans to release a generic version of Roche's rare disease drug, Evrysdi (risdiplam), which is used to treat spinal muscular atrophy (SMA) in India. The drug will be priced at roughly USD 190.80 per bottle, compared to Roche’s USD 7,440 per bottle The Delhi High Court recently ruled in favor of Natco Pharma in a patent dispute with Roche, enabling Natco to manufacture the generic drug and help provide affordable access to life-saving treatmentThe launch, however, is contingent on a pending decision from the Delhi High Court's Appellate Bench. The court has currently directed both parties to maintain the status quo
Last week, geopolitical tensions escalated as U.S. President Trump slapped trade tariffs on countries around the world. The European Commission President, Ursula von der Leyen, hels talks with European pharmaceutical industry leaders who warned that without immediate policy reform, Europe risks falling behind the U.S in the sector, particularly in the context of the dramatically changing landscapeSouth Korea's Ministry of Health and Welfare is set to reform its drug pricing system, prioritizing “social value” to strengthen the domestic pharmaceutical industry and foster economic development. By recognizing contributions like job creation, local production, and investment in clinical research, the government aims to create a “virtuous cycle” that encourages reinvestment and innovationDue to come into effect from July 1, 2025, Kazakhstan's Ministry of Health has introduced amendments to the "Pricing Rules for Medicines," overhauling how prices are calculated, regulated, and documented. One major revision includes the list of reference countries used for benchmarking medicine prices. Kyrgyzstan and Uzbekistan have been added, while several EU countries—including Greece, Latvia, Lithuania, and Romania—have been removed
Advocacy group No Patient Left Behind (NPLB) has rallied biotech stakeholders to pressure the Senate HELP Committee to protect the U.S. Food and Drug Administration (FDA) following weeks of sweeping layoffs and resignationsIn a letter addressed to HELP Committee Chairman Senator Bill Cassidy (R-LA), the NPLB urges the lawmaker to “identify where FDA’s capabilities have been impacted” by recent layoffs and other organizational changes to “quickly preserve and restore its core functions"The letter notes that adequate staffing is essential to maintain established regulatory timelines, preserving the ability to make “judgement calls” through pathways like accelerated approvals, ensuring clarity and consistency, and avoiding delays to the Prescription Drug User Fee Act. They argue that industry has already witnessed the impact of staffing shortages on these functions
On day two of Reuters Pharma Europe 2025, Brad Groves, Director of NICE Advice, engaged in a fireside discussion with Novartis’ Global Executive Director for Industry Partnerships, Matic MeglicThe speakers, representing the two sides of industry and payer, discussed the realities of implementing value-based agreements, encouraging the industry to “step into a payer's shoes to understand what evidence prioritize when negotiating price and what they constitute as value”A central message was that the success of innovative access models relies on how well their value is communicated and to who it is communicated - read on to find out more
With a lot of uncertainty still remaining around the EU Health Technology Assessment Regulation (EU HTAR) and also generally around management of high-priced, potentially one-time administration ATMPs, Christian Hill, Board Member of EUCOPE and Alexander Natz, Secretatry General of EUCOPE discuss the “Do’s and Don’ts” in this space at Reuters Pharma Europe 2025There are many factors that prohibit ATMPs from making it to patients in Europe. In the fireside chat, the speakers discuss previous market successes and failures, the nuanced issue of cross-border healthcare, and the potential for various innovative contracting arrangementsHill lauds the UK’s Highly Specialized Technologies (HST) pathway as a “leading light for what could be done for ultra-rare conditions around the world,” despite the challenges it faces, and is equally as positive about the Innovative Licensing and Access Pathway (ILAP) - read on to find out more
Launch sequencing, particularly for 27 Member States in the context of the ongoing EU pharmaceutical legislation review, was debated at Reuters Pharma Europe 2025The panel, consisting of Diana Sinkevich, Head of Market Access Rare Europe & International at Chiesi Rare Disease, Mike Ryan, EVP at Eversana, Alexander Natz, Secretary General at EUCOPE, and Janina Mette, VP, Global Marketing and Market Access at ALK, each offered unique perspectives on the challenges of launching in Europe under fluctuating conditions The wide-ranging panel touched on global issues, from the Joint Clinical Assessment (JCA) in Europe to U.S. President Donald Trump’s policies that could have a ripple effect on ex-U.S. markets - read on to find out more
During a fireside chat at Reuters Pharma Europe 2025, Francesco Di Marco, Global Head of Human Pharma Regions at Boehringer Ingelheim (BI), discussed the idea that “the enemy is disease, and we are serving the patient”Speaking with Roberto Ascione, President of Health Innovation at EVERSANA, Di Marco shared his views on innovation and regulatory reform in Europe, among other topical issuesLooking at the industry in the context of current geopolitics, his overarching message was: “I still believe in a global world. I don’t care where innovation is built, I care that it reaches patients and makes a difference”
In a fitting embodiment of its own themes, this year, Reuters Pharma Europe 2025 is offering an AI-generated summary of each session on its conference app. As someone familiar with the pharma conference circuit, this is the first offering of its kind that I have come acrossThe pertinence of this small touch clearly set the tone for a conference that has so far on day one delved into bridging the gap between technological innovation, and actually embedding these developmentsAcross the keynote sessions, three key themes emerged: how to meaningfully expand access to medicines, how to navigate policy and regulatory turbulence, and the aforementioned adoption of new technology - read on to find out more
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