Inside EU Health: EMA recommends five new medicines: Gilead HIV drug dispute; EU funds for innovative treatments; WHO extends PABS negotiations
EMA recommends five new medicines for approval; MSF denied access to Gilead HIV-prevention drug; Europe invests €244 million to fast-track next-generation treatments for deadly infections; WHO members extend negotiations on pathogen sharing framework
EMA approves five new medicines addressing rare diseases and aggressive cancers
The European Medicines Agency (EMA) has recommended five new medicines for approval following its March 2026 CHMP meeting, targeting unmet needs in oncology, rare diseases and paediatrics.
Among them, Imdylltra (tarlatamab), developed by Amgen, offers a new option for relapsed small cell lung cancer. The company said the therapy could mark “an important milestone for patients and clinicians.”
Joenja (leniolisib), from Pharming, also received backing for a rare immune disorder, with CEO Fabrice Chouraqui noting it could represent “a step-change in APDS care.”
The recommendations now move to the European Commission for final approval.
Catherine Feore
Access Denied: MSF denied access to Gilead HIV-prevention drug
Médecins Sans Frontières (MSF) has publicly challenged Gilead Sciences for refusing to sell its HIV-prevention drug lenacapavir directly, calling the decision unjustified and harmful.
The twice-yearly injectable is seen as a game changer especially for those unable to manage daily PrEP. MSF argues that restricting access is “unconscionable,” noting that its development was supported by public funding and that countries that participated in clinical trials to develop the drug are among the excluded communities.
MSF warns delays leave vulnerable populations at risk, urging immediate access and accusing the company of prioritizing “profit” over lives.
Catherine Feore
Europe invests €244 million to fast-track next-generation treatments for deadly infections
A new EU4Health Prior Information Notice (PIN), published by the European Health and Digital Executive Agency (HaDEA) with DG HERA, sets the stage for a major pre-commercial procurement (PCP) initiative on next-generation therapeutics for severe infectious diseases. With a €244 million budget, the programme aims to accelerate innovative treatments for viral infections, sepsis, and acute respiratory distress syndrome (ARDS), with a contract notice expected by May 2026.
The call will fund phased, competitive development of advanced therapeutics, including host- and pathogen-targeted approaches. It prioritises broad-spectrum and pathogen-agnostic solutions, as well as therapies designed to counter viral resistance, alongside innovative combinations and alternative delivery methods beyond intravenous use.
WHO members extend negotiations on pathogen sharing framework
Member States of the World Health Organization have agreed to extend negotiations on a key annex to the Pandemic Agreement, focusing on Pathogen Access and Benefit Sharing (PABS). Talks will resume in late April ahead of the World Health Assembly meeting in May.
The annex aims to ensure rapid sharing of pathogens and fair access to benefits like vaccines and treatments. The agreement builds on lessons from COVID-19, with the aim of strengthening global cooperation and equity in future crises.
Co-chair Tovar da Silva Nunes, from Brazil said negotiators are working toward an “ambitious and equitable” system, while co-chair Matthew Harpur from the UK welcomed “the commitment… towards finding consensus.” Countries say more time is needed to finalize the annex.