NICE for the second time recommended against reimbursing the Alzheimer's treatments Kinsunla and Leqembi, but will convene an unusual third appraisal committee meeting on the products.
Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.
A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice.
The EU, US and other countries with similar health care systems must “take responsibility” for the financial and health risks involved in getting innovative drugs, such as gene therapies, to market, says an academic expert who has worked in the advanced therapy field.
The health technology assessment institute, NICE, has reversed its rejection of Sobi’s once-weekly drug for preventing and treating severe hemophilia A, meaning that the treatment has now secured reimbursement in three European countries.
Health technology assessment agencies are willing to pay more than usual for advanced therapies that treat rare or severe diseases, but an advanced therapy for a common condition would not qualify for such a modifier, a former senior figure at England’s NICE says.
Japan's MHLW has decided to tone down planned policy revisions that would have cut benefits under a patient support scheme for high-priced drugs, after resistance from patient groups.
The leader of the House Energy and Commerce Health Subcommittee has a plan for passing pharmacy benefit manager reforms, but Democrats are skeptical.
Manufacturers still hope to advance legislation removing the “pill penalty” from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year.
The International Generic and Biosimilar Medicines Association has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?
US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
A lower asking price from BMS and more insight into the benefits Breyanzi offers have convinced the health technology assessment institute, NICE, to reverse its rejection of the one-off treatment for large B-cell lymphoma.
While CSL Behring has successfully negotiated reimbursement contracts for its one-time gene therapy Hemgenix in several European countries, it says there are still “barriers to innovative contracting solutions” in some member states that need to be addressed.
Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.
CSL Behring explains how it worked with authorities in Denmark, Austria, England, Scotland, Spain and Switzerland to secure innovative access arrangements suitable to each nation’s “unique needs” for its one-time gene therapy, Hemgenix.
US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.
Multiple, wide-ranging revisions to Japan's PMD Act, including provisions on pediatric R&D, use of real-world data and cell therapies, look set to receive formal political approval within the next few months. There is also more clarity on a controversial scheme to support venture companies.
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
The "interwoven" nature of the offices within the agency likely means Medicare and Medicaid benefits may be disrupted by staff cuts despite assurances from the administration, Brooks-LaSure warned.
The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.