Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026

Source: European Union 2

Twelve new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.

The committee recommended granting marketing authorisations for three medicines to treat adults with primary hypercholesterolaemia or mixed dyslipidaemia, conditions that cause high cholesterol levels in the blood: Lyrokaul (lerodalcibep) is an injection that patients can self-administer monthly; Evlarco (obicetrapib / ezetimibe) and Ubeslo (obicetrapib) are both oral formulations to be taken daily. All three medicines are for use in addition to diet and can be taken alone or in combination with other lipid-lowering therapies.

Susvimo (rabinizumab) received a recommendation for marketing authorisation to treat adults with neovascular (wet) age-related macular degeneration. Susvimo is delivered via a refillable implant, the first of this kind approved in the EU, inserted surgically into the eye. The implant is designed to release ranibizumab over time and is refilled every six months. Susvimo represents a new treatment option for patients. For more information read the news announcement in the grid below.

The CHMP recommended granting a marketing authorisation for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age. Icotyde is the first oral medicine that targets the protein interleukin-23 receptor, thereby reducing inflammation and symptoms associated with the disease. See more details in the news announcement in the grid below.

Lynavoy (linerixibat) received a positive opinion from the CHMP for the treatment of adults with cholestatic pruritus, a complication of an autoimmune disease called primary biliary cholangitis in which there is gradual destruction of the bile ducts in the liver. Patients who develop cholestatic pruritus experience intense itching due to a build-up of bile acids in the bloodstream.

The committee also recommended granting a marketing authorisation under exceptional circumstances for Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy, a rare genetic disorder which affects the brain, typically during childhood.

Zokovea (ensitrelvir), an antiviral medicine, received a positive opinion for the post-exposure prophylaxis of COVID-19.

The committee adopted a positive opinion for the biosimilar medicine Cavoley (pegfilgrastim) for the treatment of neutropenia (low levels of neutrophils, a type of white blood cell).

Three generic medicines received a positive opinion:

  • Riociguat Accord (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension in adults and treatment of pulmonary arterial hypertension in adults and children from 6 years of age;
  • Ruxolitinib Viatris (ruxolitinib hemifumarate) for the treatment of myelofibrosis, polycythaemia vera and graft-versus-host disease;
  • Tafamidis Accord (tafamidis) for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

Negative opinion for three medicines

The committee adopted negative opinions for three medicines:

  • KemSu (sufentanil / ketamine) for the treatment of acute pain in children aged 1 to less than 18 years.
  • Meplyffa (arimoclomol citrate) intended for treatment of Niemann-Pick disease type C, a rare, inherited, progressive neurodegenerative disorder, in patients aged 2 years and older in combination with miglustat.
  • Qezzaqar (catequentinib) intended for the treatment of synovial sarcoma or leiomyosarcoma, two types of soft tissue sarcomas (a type of cancer that affects the soft, supportive tissues of the body).

For more information on these negative opinions, see the question-and-answer documents in the grid below.

Recommendations on extensions of therapeutic indication for eight medicines

The CHMP recommended extensions of indication for eight medicines that are already authorised in the EU: Enhertu, Jivi, Piqray, Repatha, Riltrava Aerosphere, Rinvoq, Trixeo Aerosphere, and Trodelvy.

Re-examinations of initial marketing authorisation applications

The company that applied for the authorisation of Yartemlea (narsoplimab), a medicine intended for the treatment of adults and children from 2 years of age with haematopoietic stem cell transplant-associated thrombotic microangiopathy, and the company that applied for the authorisation of Xervyteg (allogeneic faecal microbiota, pooled), a medicine developed to treat acute graft-versus-host disease, have requested re-examinations of the negative opinions adopted during the committee’s June 2026 meeting. 

Question-and-answer documents on the refusal of marketing authorisations for these medicines are available on EMA’s website.

Withdrawal of applications

An application for initial marketing authorisation for Azacitidine Adienne (azacitidine), for the treatment of adults with certain disorders and cancers of the blood and bone marrow when they cannot have haematopoietic stem cell transplantation, was withdrawn. A question-and-answer document on the withdrawal of this application is available in the grid below.

Two applications for extensions of indications were withdrawn: one to extend the use of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid, an autoimmune skin disease that causes widespread itching and blisters affecting the skin and sometimes the inside of the mouth; and one to extend the use of Imfinzi (durvalumab) for the treatment of high-risk non-muscle-invasive bladder cancer, a type of cancer that affects the lining of the bladder.

Question-and-answer documents on the withdrawal of these two applications are available in the grid below.

Other updates

The CHMP gave a positive opinion to update the composition of the vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the new XFG variant of the virus that causes COVID-19. The revision of these vaccines is in line with the recommendation issued by EMA’s Emergency Task Force for the 2026/2027 vaccination campaign.

Agenda and minutes

The July 2026 CHMP meeting agenda is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.

CHMP statistics

Key figures from the July 2026 CHMP meeting are represented in the graphic below.

ASIA/LEBANON – The beatification of Patriarch Hoyek in Lebanon’s new time of trial

Source: Agenzia Fides – MIL OSI

by Pascale RizkDimane (Fides News Agency) – On Saturday, July 25, 2026, the Maronite Church and the whole of Lebanon celebrate the beatification of Patriarch Elias Hoyek. The beatification liturgy, presided over by Cardinal Marcello Semeraro, Prefect of the Dicastery for the Causes of Saints, will be held at the Maronite Patriarchate’s summer residence in Dimane, overlooking the Qannoubine Valley.Two years ago, the Patriarchal See of Bkerké, the principal residence of the Maronite Patriarchate, hosted the first-ever beatification of a Maronite Patriarch, that of Patriarch Estephan al-Douaihy, on August 2, 2024. (See Fides, 3/8/2024)Widely regarded as one of the founding fathers of ‘Greater Lebanon’ and as a spiritual leader who profoundly shaped the country’s history, Elias Hoyek was born on December 4, 1843, in Helta, northern Lebanon, into a Maronite family deeply rooted in the mountain communities where ecclesial life and the bond with the land are inseparable.At the age of eight, he entered the School of St. John Maroun in Kfarhi before continuing his studies at the seminary in Ghazir. In 1866, Patriarch Boulos Massaad (1806–1890) sent him to Rome to complete his theological formation at the Pontifical Urban College of Propaganda Fide. He was ordained a priest on June 5, 1870, earned a doctorate in theology on August 9, and soon afterward returned to Lebanon.Back in his homeland, Hoyek was appointed secretary to Patriarch Massaad in Bkerké in 1872, the institutional heart of the Maronite Patriarchate. During these years he conceived the idea of establishing an apostolic congregation of women religious dedicated to reaching the peripheries of education and healthcare, at the service of the people in the name of the Gospel.On December 14, 1889, he was consecrated bishop, becoming Titular Archbishop of Araca and Patriarchal Vicar. His ministry combined ecclesial governance the promotion of catechesis and practical concern for Lebanon’s social needs.In 1895, in Jbeil, together with Mother Rosalie Nasr and Sister Stéphanie Kardouch, he founded the Congregation of the Maronite Sisters of the Holy Family, the first apostolic women’s religious institute of the Maronite Church. The congregation soon established itself in Ebrine and devoted its mission to education, human development, and evangelization.The congregation describes its founder as “a man of great character, leader and shepherd of his Church, attentive to the needs of society and constantly listening to his people,” emphasizing his ability to combine firm leadership with pastoral closeness.In 1908, Hoyek erected the Shrine of Our Lady of Lebanon in Harissa, where Pope Leo XIV met bishops, priests, consecrated men and women, and pastoral workers during his Apostolic journey to Lebanon in November 2025.On December 7, 1899, Elias Hoyek was elected the 72nd Maronite Patriarch of Antioch, assuming leadership of the Church at a decisive historical moment marked by the decline of the Ottoman Empire, the crisis of the First World War, and the rise of new national aspirations across the Levant.During the famine that ravaged Lebanon between 1915 and 1917, in 1916 he ordered monasteries and convents to open their doors to welcome those who were starving, regardless of religious affiliation. The Ottoman authorities decided to deport him, but the measure was ultimately prevented through the intervention of the Pope and Austro-Hungarian diplomacy.As a result, the Patriarch came to be regarded not only as the spiritual leader of the Maronite Church, but also as a defender of the Lebanese people and of their dignity.In 1919, he represented Lebanon at the Versailles Peace Conference, leading a delegation that called for the country’s independence and for recognition of Lebanon’s “natural and historical frontiers,” in accordance with Article 22 of the Covenant of the League of Nations.At a time when the project of a “Greater Syria,” backed by King Faisal and the emerging mandate system, Hoyek argued forcefully that Lebanon’s autonomy should be guaranteed in light of the nation’s unique history, culture, and religious composition.Among the Patriarch’s most significant writings is the apostolic letter “Love of the Homeland”, published in 1930, in which he urged every citizen to assume responsibility for the nation.”Whether you are humble or great,” he wrote, “you are not permitted to withdraw from the destiny of the Nation and from the progress of the society to which you belong,” linking love of country with justice toward others and commitment to the common good.In the same text, he added that “those who refuse to help their country sin not only against charity, but also against justice,” insisting that participation in civic life forms part of the Christian’s moral responsibilities.Read today in the light of his beatification, these words resonate as a renewed appeal for political and social responsibility in a Lebanon that continues to endure years of profound crisis.On September 1, 1920, from the balcony of the French Mandate headquarters in Beirut, General Henri Gouraud proclaimed the establishment of the State of Greater Lebanon, encompassing the mountains, the plains, and access to the Sea. According to historical accounts, Patriarch Hoyek stood at his right, surrounded by dignitaries and representatives of the country’s various religious communities.That moment gave institutional expression to a vision traditionally summarized in Maronite thought by the triad: “freedom, Lebanon, Patriarchate”, freedom as a non-negotiable value, Lebanon as a blessed land, and the Patriarchate as guardian of the nation’s historical memory and orientation of the people.Pope Leo XIV’s decision to approve Hoyek’s beatification, following Pope Francis’ recognition of his heroic virtues in 2019, places him among the great Lebanese saints whom the Church proposes as universal models of evangelical life, including St. Charbel Makhlouf.The miracle recognized for the beatification concerns the healing, in 1965, of Nayef Abou Assi, a Druze officer in the Lebanese Army suffering from a serious spinal illness. According to the testimony, he awoke completely healed after dreaming of the Patriarch.During the final years of his life, the Patriarch closely accompanied the growth of the Maronite Holy Family, approving their constitutions in 1928 and accompanying his religious “daughters” with words of comfort and encouragement. Hoyek died on Christmas Eve, December 24, 1931, in Bkerké. His remains rest in Ibrine, in the chapel of the congregation he founded, symbolically sealing the bond between his patriarchal ministry, consecrated life, and educational mission.With the decree of beatification promulgated by the Dicastery for the Causes of Saints and authorized by Pope Leo XIV on May 22, 2026, the Church formally recognizes the holiness of a shepherd who united love of country, political wisdom, and evangelical commitment to the most vulnerable, at a time when Lebanon still awaits signs of social and institutional renewal and resurrection.(Fides News Agency, 24/7/2026)
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At the Shrine of Banneux, the first Marian Missionary Festival: Mary, face of dialogue and mission in Asia

Source: Agenzia Fides – MIL OSI

by Marie-Lucile KubackiBanneux (Fides News Agency) –Showing the link that unites devotion to the Mother of God with the missionary vocation, and the joy of proclaiming the Gospel, an experience open to every baptized person: this is the heart of the first edition of the Marian Missionary Festival, which will take place at the Shrine of Our Lady of Banneux, Belgium, on Sunday, July 26, 2026. Organized by the Pontifical Missionary Union (PMU) in collaboration with the European Vietnamese Pilgrimage Community, this unprecedented event gathers faithful and missionaries around the Marian figure, whose devotion is widespread across the Asian continent. As Father Dinh Anh Nhue Nguyen (OFMConv), Secretary General of the Pontifical Missionary Union, explains: “This is the first edition of a festival that brings together the Marian matrix and the missionary matrix. Marian devotion, deeply felt in Asian countries, unites with the missionary commitment of all the baptized. They are called to be missionary disciples like Mary.”On the occasion of this first edition, a Mass of Thanksgiving will be celebrated for the beatification of the martyr priest Francis Xavier Trương Bửu Diệp on July 2, 2026, an event of major significance as it was the very first beatification ceremony ever celebrated on Vietnamese soil. The Eucharistic celebration (in Vietnamese) will be presided over by His Excellency Most Rev. Frédéric Rossignol, Bishop of Tournai. Prior to the Mass, two conferences—given in English and Vietnamese—will be led by Father Anthony Chantry (MHM), National Director of Missio for England and Wales, and Father Dinh Anh Nhue Nguyen.Father Anh Nhue indicates that these teachings “will focus on aspects of living and witnessing to the faith in all circumstances of life, whether at the parish, at work, at school, and in the family, and therefore also on martyrdom, around the promise of Christ who came ‘to give his life’ so that his sheep ‘may have life in abundance.'” He also emphasizes that this perspective aligns with the Pope’s message for the upcoming World Mission Sunday, in which the Sovereign Pontiff highlights the “Mission of Love.”By placing the Mother of Christ at the center of this festival, the organizers also highlight an important reality of spiritual life in Asia: Marian devotion as a privileged locus of inculturation and intercultural encounter on the continent. But how? And what conclusions can missionaries draw from this observation?Mary, Bridge Between Believers and CulturesOn Sept. 12, 2023, the US-based Pew Research Center released an important survey on Buddhism, Islam, and religious pluralism in South and Southeast Asia, interviewing more than 12,000 people from Thailand, Cambodia, Malaysia, Singapore, and Indonesia. The survey indicated that numerous non-Christians venerated Mary. In order to gain an in-depth understanding of how Asian Christians and non-Christians approach the Mother of Christ, the Initiative for the Study of Asian Catholics (ISAC)—an international academic network hosted by the Asia Research Institute at the National University of Singapore—partnered with the Center for Marian Studies in London to conduct a research conference entitled “More Universal than Catholicism? Mary Among Asian Religions.” Gathered in mid-May 2023, this conference featured 18 research papers exploring Marian devotions in 11 countries and across five religious traditions.Theologian and anthropologist Michel Chambon, coordinator of ISAC, presented the findings in World Mission Magazine, noting that the Virgin Mary transcends religious boundaries, and highlighted several key examples. At Novena Church in Singapore, as well as at the pilgrimage sites of Velankanni in India or Mariamabad in Pakistan, thousands of Muslim and Hindu devotees regularly come to entrust their petitions and make vows to Mary. In Singapore, the movement Origin of the Self, rooted in a Taoist worldview and founded by Professor Zhang Bu Sheng, integrates Mary into its pantheon alongside Jesus and St. Joseph. For these devotees, physical maternity does not really matter; for them, seen from the perspective of their beliefs, the figure of Mary rather embodies the perfect model of a person who, “through her meditation and virtue, she engendered a divine being from within and overcame death,” illustrating “the universal capacity that humans have to engender a higher being from within and to transcend death.” In East Asia, Mary coexists with female deities such as the Bodhisattva Guanyin or the goddess Mazu in Taiwan. From Japanese Edo-period statues (Maria Kannon) to hidden Qing dynasty paintings strategically attributed to the artist Tang Yin to avoid political scrutiny, to contemporary Korean granite statues sculpted by Choi Jong-Tae in the 6th-century Buddhist style, the Marian figure engages in deep dialogue with Asia’s artistic and spiritual heritage.Michel Chambon also points out that the attraction to Mary is rooted in the intimacy of homes, where her images sometimes sit alongside other spiritual figures (such as Guanyin in Chinese-Filipino households). The domestic sphere thus becomes a key site of a “lived religion.”Furthermore, the cultural reappropriation of figures like Our Lady of La Vang in Vietnam, represented since the late 1990s wearing traditional Vietnamese outfits (áo dài) and a golden headdress, illustrates how Catholicism continuously recasts itself as an authentically Asian faith. “Asian devotions highlight her centrality to the dialogue that Asian people cultivate with Christian and non-Christian traditions,” states Michel Chambon. “Mary in Asia remains an intriguing question taking us beyond our comfort zone. With her colorful devotees, she is a challenging figure who invites us to reconsider our religious position and the ways we conceptualize religion, Catholicism, and interfaith dialogue.”By gathering the community in Banneux, this first Marian Missionary Festival illustrates that mission is above all a matter of encounter: one embodied by the witness of martyrs, and one that Mary continues to foster among cultures and believers throughout the world. (Fides News Agency, 24/7/2026)
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Press conference following Council of Ministers meeting no. 182

Source: Government of Italy (English)

23 Luglio 2026

Council of Ministers meeting no. 182 was held at Palazzo Chigi today. Following the meeting, Minister of Justice Carlo Nordio, Minister for Public Administration Paolo Zangrillo, Minister of University and Research Anna Maria Bernini, Minister of Labour and Social Policies Marina Elvira Calderone and Undersecretary of State to the Ministry of the Interior Emanuele Prisco held a press conference to illustrate the measures approved.

[The press conference]

No change to the policy rate: what I will be watching before September

Source: Central Bank of Ireland

24 July 2026 Blog

This week my ECB Governing Council colleagues and I decided to leave interest rates unchanged. The Deposit Facility Rate, through which we steer the monetary policy stance, remains at 2.25 per cent.

That decision followed June’s move, when the Governing Council raised rates for the first time since 2023, citing the inflationary pressures stemming from the conflict in the Middle East and its effect on energy prices.

Those inflationary pressures have not gone away. Indeed, following the collapse of the truce and a return to hostilities, there is renewed upward pressure on energy prices. Despite this, the decision not to change rates this week primarily reflects our judgement that, with the effects of the June increase still working through the economy and with limited data since our last meeting, the right course is to observe carefully how the data evolve before drawing further conclusions. With updated projections at our next meeting in September we will be able to more confidently assess the appropriate stance in order to achieve our 2 per cent inflation target over the medium term.

Inflation: a moving picture

The most recent euro area headline inflation estimate for June of 2.8 per cent was lower than some had anticipated, including us. Market surveys and our own analysis had pointed to something closer to 3 per cent. The main driver of the downside surprise was commodity, and primarily energy, prices, which fell through much of June. Since early July, however, energy prices have rebounded, and our latest internal estimate puts euro area inflation back in the region of 3 per cent for the euro area.

A new Staff Insights piece published today by Joe Marlow and Dilan Aydın Yakut (“Nowcasting Euro Area Inflation”) describes our framework for tracking inflation in something closer to real time. The June episode is a good illustration of why this kind of tool matters. The nowcasting model tracked the June cooling as it happened, and has since tracked the reversal. That granularity is useful for the Bank, and I hope for the broader public conversation about where near-term inflation is heading.

What I will be watching before September

July was a non-projection meeting, which means the Governing Council’s next full read of the economic outlook comes in September, including updated staff forecasts. Between now and then, we will have two further euro area inflation prints (for July and August) and a first estimate of Q2 GDP. In the context of ongoing volatility and a wide range of potential outcomes for growth and inflation depending on the path for energy prices (as the scenario analysis in March and June showed), this is meaningful new information.

A few things I will be paying particular attention to. First, whether the recent rebound in energy prices proves sustained or fades. That will be the single biggest determinant of headline inflation in the near term, as we saw more recently. Second, the path of core inflation, which has been more stable but which I do not take for granted, particularly given the typical pattern of staggered wage adjustment in the euro area. This will help us understand the extent to which indirect effects of the energy shock are intensifying or if second-round effects are emerging. Third, growth: the June staff projections put euro area GDP growth at 0.8 per cent for this year, and subject to downside risk. The transmission of June’s rate increase into credit conditions and broader activity will be something we monitor carefully.

The Irish Picture

The Irish economy entered this period of geopolitical uncertainty and energy-market volatility from a strong position, though as I noted in my pre-Budget letter last week, there are underlying vulnerabilities that deserve careful attention as we approach the autumn.

Irish inflation has broadly tracked the euro area pattern, rising sharply in March as energy prices jumped on the start of the war, before falling back a little in June to 3.2 per cent. I have Tracing energy shocks through the Irish supply chain: A new monitoring framework”) quantifies these channels. Because the estimates are static – not attempting to model dynamic supply and demand responses or second-round effects – they provide a clear baseline for monitoring how energy shocks propagate through the economy. Following an increase in energy commodity prices, around one quarter of the estimated increase in price level comes indirectly via the supply chain of non-energy goods and services, with the rest coming from direct effects.

The framework also identifies where these indirect effects are most pronounced. Transport services show the strongest impact, followed by clothing and textiles, transport goods (excluding fuels), household durables, alcohol and tobacco, and food. Labour-intensive services – health, financial services, restaurants and accommodation – show weaker indirect effects, since wages rather than energy and other inputs dominate their cost structures. For these services, how wages respond to the initial shock (the so-called ‘second-round’ effects) will be a factor in determining whether this episode feeds into more persistent, broad-based inflation.

Summing up

The Governing Council acted in June when the data indicated it was necessary. Yesterday’s decision to hold rates was a prudent, considered one. We remain firmly committed to returning inflation to our 2 per cent medium-term target and will continue to be guided by what the evidence tells us, meeting-by-meeting. September’s meeting, with its updated projections and a richer information set, will provide greater clarity on the path ahead. Until then, the data will keep moving, and so will our attention to it. Understanding these transmission channels – direct, indirect, and through wage adjustment – is essential to our assessment of inflation dynamics and our policy response. It is why we will be watching core inflation and wage developments so carefully in the months ahead.

Gabriel Makhlouf

ECB to extend use of climate factors in Eurosystem collateral framework to non-financial corporate credit claims

Source: European Central Bank

24 July 2026

  • Climate factor extension to protect Eurosystem against potential decline in collateral value due to climate-related transition shocks
  • Measure complements existing risk control framework and increases resilience of monetary policy implementation
  • Implementation by end-2027 at earliest, with climate factor values updated annually

The Governing Council of the European Central Bank (ECB) has decided to extend the use of climate factors in the Eurosystem collateral framework to certain eligible credit claims whose debtor is a non-financial corporation. The extension is designed to further strengthen the Eurosystem’s risk management framework by addressing financial uncertainties related to the green transition. The measure builds on the introduction of a climate factor for marketable assets issued by non-financial corporations and their affiliated entities, which was approved in July 2025 and became effective on 15 June 2026.

Collateral pledged by counterparties in Eurosystem refinancing operations may be exposed to unexpected climate-related transition shocks, such as changes in climate policy, technological developments, shifts in consumer behaviour, litigation and broader macroeconomic adjustments. These factors may affect the value of collateral, including credit claims, at times when the Eurosystem might need to liquidate such assets.

The higher the sensitivity of the collateral to climate uncertainties, the greater the reduction applied to its collateral value. The climate factor will be based on an asset-level uncertainty score comprising three elements: a sector-level stressor derived from the latest Eurosystem climate stress test, the debtor’s exposure to transition-related uncertainties and the residual maturity of the credit claim. The Eurosystem may rely on sector-level data, or alternative data suited to assess the risks in question, where industry-level or debtor-level data are unavailable.

The maximum additional reduction in the final collateral value, including both bonds and credit claims, will be 5%. Climate factors for individual credit claims will not be publicly disclosed.

This measure is expected to be implemented at the earliest by the end of 2027. Climate factor values will be updated annually, following the same process as for non-financial corporate bonds, to incorporate the latest available climate-related data.

For media queries, please contact William Lelieveldt, tel.: +49 170 2279090.

First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis

Source: European Union 2

EMA has recommended granting a marketing authorisation in the European Union for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and in adolescents from 12 years of age weighing at least 40 kg.

Plaque psoriasis is a common chronic inflammatory skin disease affecting around 1% to 4% of adults and up to 1% of children worldwide. The condition can have a significant impact on people’s quality of life, causing both physical and psychological discomfort.

Although a range of treatments is available, there remains a need for effective, safe and convenient treatments for this condition. Many patients do not achieve adequate control of their symptoms, and the effects of treatment can wane over time. Some patients also experience significant side effects.

The active substance in Icotyde, icotrokinra, works by blocking the receptor for interleukin-23, a protein that plays a role in the inflammation seen in plaque psoriasis. By blocking the action of interleukin-23, icotrokinra reduces inflammation and symptoms associated with the disease.

While authorised injectable medicines targeting interleukin-23 are available in the EU, Icotyde will be the first authorised oral medicine targeting the interleukin-23 pathway.

In reaching its opinion on Icotyde, EMA considered data from four phase 3 trials involving 2,500 patients with moderate-to-severe plaque psoriasis.

In three of these studies, after 16 weeks, between 50% and 57% of patients who took Icotyde achieved PASI 90 (a 90% or more drop in symptom scores as measured by the Psoriasis Area and Severity Index), compared with between 1% and 4% of patients who took placebo (a dummy treatment). In addition, between 65% and 71% of patients who took Icotyde achieved an IGA score of 0 or 1, meaning their skin was clear or almost clear of psoriasis lesions, compared with 8% to 11% of those who took placebo.

A fourth study involved patients with psoriasis affecting difficult-to-treat areas such as the scalp, genital region, hands and feet. 

Icotyde also has a favourable safety profile. The most common side effects reported were fungal infections, which occur in 1.1% of patients.

The opinion adopted by the CHMP is an intermediary step on Icotyde’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU‑wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.


Note: The applicant for Icotyde is Janssen-Cilag International N.V.

The EBA seeks feedback on the 4.4 draft technical package of its reporting and disclosure framework

Source: European Banking Authority

The European Banking Authority (EBA) today published a draft technical package for version 4.4 of its reporting and disclosure framework, covering IFRS 18 reporting, Pillar 3 ESG disclosures and other technical amendments.

This early release is intended to support reporting entities in preparing for upcoming changes ahead of the final publication, scheduled for September 2026. The EBA invites stakeholders to provide feedback on both the draft technical package and the accompanying glossary.

The draft technical package for release 4.4, includes validation rules, the Data Point Model (DPM) and XBRL taxonomies, and introduces the following new reporting requirements:

  • Amendments to the ITS on Pillar 3 disclosures on ESG risks, equity and shadow banking exposures published here. The first reference date is 31/12/2026 (31/12/2027 for SNCIs);
  • New IFRS 18-aligned templates in Supervisory Financial Reporting (FINREP) framework. These templates should be read in conjunction with the EBA Opinion and related Annexes published here. The first reference date is 31/03/2027;
  • The integration of FRTB-related disclosures templates into the DPM. The first reference date is 31/03/2027;
  • Technical amendments to DPM and taxonomy related to Resolution Planning, MREL decisions and Pillar 3 disclosure templates. The first reference date is 31/12/2026;
  • DPM and taxonomy to Anti Money Laundering Authority (AMLA)- Eligibility templates. The first reference date is 31/12/2026.

Background, consultation process and next steps

The final technical package for reporting framework 4.4 will be published in September 2026 and will reflect necessary amendments following stakeholder review. This draft publication aims to provide additional implementation time for institutions and to enable the EBA to gather early feedback ahead of finalisation. This version relates to phase 1 of the 4.4 release, as indicated on the EBA Reporting frameworks webpage. The second phase of 4.4 (4.4.1) will include the rest of the topics included in the consultation paper on major simplification of supervisory reporting, published on 10 April.

This release includes the technical amendments and corrections to DPM for resolution planning and Pillar 3 disclosure templates, as identified in the list of DPM known issues published by the EBA on 9 April.

Finally, this draft framework reflects the impact of the third FRTB Delegated Act on disclosures. Further details will be communicated by the EBA soon. Stakeholders are invited to submit comments and suggestions on the draft technical package 4.4 and the new glossary by 24 August 2026, using the EBA feedback form.

In June 2024, the EBA published its plan for the implementation of DPM 2.0. The draft technical package for version 4.4 published today, continues the transition to DPM 2.0 and to the new glossary. This draft technical package includes a new version of the conversion file between DPM 1.0 and DPM 2.0 glossary.

Disclaimer: This draft technical package is provided for information purposes only. The final package will include additional elements not yet covered, notably the validation rules on anti-money laundering (AML)-eligibility and the revised version of the AMLA risk assessment 2027 data collection exercise templates.

Results of the June 2026 survey on credit terms and conditions in euro-denominated securities financing and OTC derivatives markets (SESFOD)

Source: European Union 2

24 July 2026

The June 2026 survey covered a period of heightened market volatility from March to May 2026. Escalating conflict in the Middle East triggered an oil supply shock that drove commodity prices sharply higher. This weighed on risk sentiment in March, while in April and May markets recovered strongly. Over the review period, market-implied policy rate expectations rose considerably. Against this backdrop, credit terms and conditions proved broadly resilient, with survey respondents reporting that overall terms had eased slightly for all counterparty types for a second consecutive quarter. The easing was due entirely to price terms, as non-price terms remained basically unchanged across the board. Looking ahead, respondents expected credit terms to remain basically unchanged from June to August 2026, with only a very small net percentage expecting price terms to tighten somewhat for banks and dealers (Chart 1).

Chart 1

Expected and realised quarterly changes in overall credit terms and price/non-price terms offered to counterparties across all transaction types

(net percentages of survey respondents)

Source: ECB.

Note: Net percentages are calculated as the difference between the percentage of respondents reporting “tightened somewhat” or “tightened considerably” and the percentage reporting “eased somewhat” or “eased considerably”.

In the securities financing markets, financing rates/spreads rose across all collateral types, with significant increases reported for asset-backed securities (a net 31% of respondents), high-yield corporate bonds and domestic government bonds (a net 29% of respondents in each case, as shown in Chart 2). Simultaneously, the demand for funding grew across almost all collateral types, particularly for funding secured against equities (a net 33% of respondents), which experienced a strong recovery in collateral values. Dealers responded by reducing the maximum amount and maturity of funding available for several types of bond collateral, while increasing the availability of funding secured against equities. The liquidity and functioning of collateral markets showed a slight deterioration for equities, high-yield corporate bonds and high-quality financial corporate bonds. At the same time, the volume of collateral valuation disputes rose across all collateral types, highlighting heightened challenges in market dynamics.

Chart 2

Changes in financing rates and demand for funding by collateral type (Q2 2026)

(net percentages of survey respondents)

Source: ECB.

Note: Net percentages are calculated as the difference between the percentage of respondents reporting “tightened somewhat” or “tightened considerably” and the percentage reporting “eased somewhat” or “eased considerably”.

Amid the heightened market volatility, there were also some signs of friction in non-centrally cleared over-the-counter derivatives markets. Initial margin requirements increased slightly for most types of derivative, most notably interest rate derivatives, reversing the slight decreases reported in the previous quarter. Liquidity and trading deteriorated slightly for foreign exchange, equity and commodity derivatives, and the volume of valuation disputes increased for several types of derivative, in particular equity derivatives, while the duration and persistence of disputes changed little. The maximum amount of exposure rose slightly for interest rate, credit and equity derivatives.

The full survey results – including detailed breakdowns by counterparty type, collateral type and derivative type, as well as comparisons with previous survey rounds – are presented in the summary report.

The results of the June 2026 SESFOD survey, the underlying detailed data series and the SESFOD guidelines are available on the ECB’s website, together with all other SESFOD publications.

Please note that the data from all previous rounds of the survey have been made available on the ECB Data Portal. The data can now be accessed, retrieved and visualised more easily.

The SESFOD survey is conducted four times a year and covers changes in credit terms and conditions over three-month reference periods ending in February, May, August and November. The June 2026 survey collected qualitative information on changes between March and May 2026. The results are based on responses received from a panel of 26 large banks, comprising 14 euro area banks and 12 banks with head offices outside the euro area.

For media queries, please contact Esther Tejedor, tel.: +49 1725171280.

North Macedonia launches regional campaign on LIFE Programme 2026 funding opportunities

Source: European Union 2

Organised under the eHUB4LIFE project, the campaign built on the National EU LIFE Info Day held in Skopje on 13 May. It then moved into a series of regional events held between 26 June and 13 July in Gostivar, Tetovo, Bitola, Struga and Skopje. In total, more than 220 representatives from public institutions, universities, businesses and civil society took part.

The sessions focused on the 2026 LIFE Calls for Proposals, giving participants practical guidance on eligibility rules, funding arrangements and application procedures. Experts involved in eHUB4LIFE also shared lessons from previous projects and highlighted common difficulties applicants face when preparing proposals.

A central aim of the campaign was to encourage stronger engagement with LIFE priorities, including biodiversity protection, climate adaptation and the clean energy transition. Organisers invited participants to shape project ideas that respond both to EU policy goals and to North Macedonia’s own environmental challenges. Through questionnaires and question-and-answer sessions, attendees were also able to point to the kinds of technical support they still need.

The opening event in Gostivar underlined the political significance of the initiative. It included contributions from EU Ambassador Michalis Rokas, Environment Minister Muamet Hoxha and Gostivar Mayor Valbon Limani, signalling broad support for greater use of EU environmental and climate funding. Their presence reflected the view that access to LIFE support is strategically important for the country as it works on issues such as waste management and climate resilience.

By taking the campaign beyond the capital, organisers aimed to widen the pool of future applicants and strengthen cooperation across municipalities, academia, business and civil society. According to the information provided, many participants showed interest in preparing joint proposals, especially in areas such as the circular economy and biodiversity.

The campaign appears to have created useful momentum as it offered a space for networking, capacity-building and early technical guidance, while also helping identify where more support is needed. The eHUB4LIFE project is expected to continue this work through further information activities and mentoring, with the goal of improving North Macedonia’s ability to secure LIFE Programme funding in the years ahead.

North Macedonia joined the LIFE Programme in 2023.