Europe

The Danish regulator says the new stockpiling and reporting requirements will give stakeholders time to take steps to mitigate the impact of long-term supply issues, but the pharma industry body, LIF, fears the move could create more problems than it will solve.

The EMA is proposing to update its two previous guidelines on COVID-19 vaccines to offer consolidated advice on the non-clinical and clinical development of new SARS-CoV-2 or related sarbecovirus vaccines.

At a panel on value added medicines at Medicines for Europe’s 30th annual conference in Dublin, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing.

After an initial funding rejection last year, CSL Behring’s gene therapy for hemophilia B is to be made available to English patients under the Innovative Medicines Fund via a “first-of-its-kind” agreement. Hemgenix is also the subject of a funding deal in Denmark.

The EU guideline on clinical investigation of medicinal products for psoriatic arthritis needs updating, including revised recommendations on the selection of the primary endpoint.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

The R&D-based pharma industry has welcomed the “more careful and considered approach” taken by EU ministers to the European Commission’s proposed compulsory licensing system, but says there is room for further improvement.

The off-label “cosmetic” use of GLP-1 receptor agonists such as Ozempic and Wegovy is contributing to global shortages of these drugs, prompting the European Medicines Agency to ask member states and manufacturers to “control and optimize” their use.

The Council of the EU says it has produced a “well balanced” text in response to the proposals on tackling medicine shortages in the pharma reform package, and has flagged up a number of areas where it wants more clarity.

Two new pieces of guidance, from the EMA and the HTA coordination group respectively, should help companies understand which drugs must undergo an EU-wide joint clinical assessment and how to notify the relevant authorities about them.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

The European Commission has published draft procedures for how the European Medicines Agency is to share information relating to joint clinical assessments with the Member State Coordination Group on HTA.

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

The former head of the European Medicines Agency’s Data Analytics and Methods Task Force says sponsors should engage early with regulators to get feedback on the suitability of real-world data for a regulatory application. However, industry suggests developing a fitness-for-purpose framework with specific criteria to determine when RWD may be appropriate.

EU citizens can access medical treatments in countries other than their own through cross-border health care regulations – but these legislations were not built with advanced therapy medicinal products (ATMPs) in mind, experts warn.