The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.
Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.
The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.
The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.
Decentralized manufacturing methods for cell and gene therapies will be critical for improving patient access to treatments, but sponsors must prepare to demonstrate “comparability” with centralized manufacturing.
It is time for a much greater focus on pull incentives to ensure viable market conditions for medicines for neglected diseases that are traditionally regarded as unprofitable.
More details on how the EU network of medicines agencies plan to leverage AI and foster competitiveness is now available in their draft 2025-2028 strategy, which they have published for comment.
Europe Must Turn To Science Diplomacy With Developing Countries To Counter Tomorrow’s Health Threats
Public-private partnerships can help industry better understand neglected diseases and develop potential treatments.
Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.
Issues raised in the first six months of the new VPAG include potential adverse impacts on both older and newer innovative drugs, as well as uncertainties over the “exceptional circumstances” clause that allows requests for price increases or cuts in repayment rates.
Having its own priority review vouchers could serve as an important pull incentive for neglected disease R&D in Europe, although the unpredictable nature of the vouchers may deter some investors.
Having its own priority review vouchers could serve as an important pull incentive for neglected disease R&D in Europe, although the unpredictable nature of the vouchers may deter some investors.
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile.
New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.
NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.
There is “a lot of flexibility” in the European Medicines Agency’s reflection paper on the use of artificial intelligence during drug development, which is principles-driven rather than setting rigid recommendations, says the agency’s Florian Lasch.
Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.
Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.