This year's European Society of Cardiology (ESC) Congress showed just how quickly cardiology is changing. Late-breaking trials, new scientific data and major guideline updates all pointed to a field that is becoming both more crowded and more complex.

A central question the conference sought to address was how effectively the two main types of ATTR-CM treatment work. Stabilizers are designed to prevent the transthyretin protein from breaking apart, while silencers reduce its production. The debate centered on whether silencers offer enough additional benefit over established stabilizers in this significant rare disease market.

One of the clearest lessons was that the challenge is no longer simply bringing more treatments to market. It is increasingly about finding the right patients earlier, understanding how different therapies compare and deciding where each option fits as standards of care improve. ATTR-CM was one of the strongest examples of that shift, with the conference data sharpening the debate over whether silencers offer enough additional benefit over established stabilizers. The same pattern could also be seen in new guidelines and in the growing role of digital monitoring.

Alnylam ($ALNY) faces new questions over Amvuttra in ATTR-CM

Alnylam Pharmaceuticals came to ESC looking to strengthen the case for Amvuttra in ATTR-CM, but the data arguably leave some important questions unanswered. While the drug is already approved, the estimated benefit appeared more modest than many investors and clinicians may have hoped, particularly given the growing expectation that newer therapies will need to demonstrate clear advantages over established treatments. The key question is whether ATTR-CM silencer treatments offer enough additional benefit on top of stabilizers that are already delivering meaningful clinical outcomes.

In light of this, there remains uncertainty around the extent of Amvuttra's value and whether it will be sufficient to secure a strong position in an increasingly competitive market. The FDA's decision earlier this year to challenge Alnylam's survival claims based on an open-label extension of HELIOS-B only adds to the need for caution. It is, therefore, perhaps unsurprising that Alnylam's share price has come under pressure and that questions are being raised about the long-term commercial viability of Amvuttra in ATTR-CM.

Rather than definitively strengthening the case for Amvuttra, Alnylam's participation at ESC suggests that important questions remain about the true scale of its advantage and whether the evidence is sufficient to establish a clear benefit over existing treatments.

AstraZeneca ($AZN) casts further doubt on silencers in ATTR-CM

In perhaps a similar spirit, AstraZeneca and Ionis used ESC to revisit the results of the Phase 3 CARDIO-TTRansform trial of Wainua (eplontersen), another potential treatment for ATTR-CM. They faced a somewhat different challenge, however, as the trial had already failed its primary endpoint, with Wainua unable to significantly reduce cardiovascular mortality and recurrent cardiovascular events in the overall study population.

The companies sought to contextualize the findings, but the presentation arguably highlighted one of the trial's central challenges. If the apparent benefit is less clear among patients already receiving stabilizer therapy, the data raise broader questions about how much additional value silencers can deliver beyond treatments that are already producing meaningful clinical outcomes. The broader question, however, is what this means for an ATTR-CM market that is becoming increasingly competitive. As new treatments emerge, should attention shift towards newer therapies, or remain focused on established stabilizers that may already be providing much of the available benefit?

New ESC guidelines and Huawei point to a prevention first approach

ESC also saw the release of new guidelines that could change how cardiovascular patients are identified and managed. The updated heart failure guidance simplifies how patients are classified and puts more focus on prevention and earlier intervention. In practice, that means clinicians may be looking for risk earlier and across a broader group of patients, rather than waiting until disease is more advanced.

That change is creating more room for digital tools. Huawei used ESC to preview its Watch D3, a wrist-based ambulatory blood pressure monitor designed to track blood pressure in everyday settings. It is one example of how wearables are moving beyond basic wellness tracking and towards data that could help identify risk earlier, monitor patients more closely and support treatment decisions.

Reflecting on ESC 2026, ATTR-CM emerged as a key area of focus. The AstraZeneca and Alnylam data raised questions about whether silencers can offer enough benefit over established stabilizers, while new guidelines and digital tools highlighted the importance of identifying risk earlier and monitoring patients more closely. The key question now, arguably, is which approaches can genuinely improve on what is already available, and which patients are most likely to benefit.

Iranian officials say a meeting with Gulf states to discuss the Strait of Hormuz has been postponed, dealing a blow to efforts to reopen the strait.

On 11 September, the Commission presented its proposal on the EU-Ecuador Sustainable Investment Facilitation Agreement (SIFA) to the Council for its signature and conclusion.  

This is the first SIFA negotiated with a Latin American country and will help promote further EU investment in Ecuador. The EU-Ecuador SIFA aims to make it easier for EU companies to invest and expand their operations in Ecuador. It benefits both EU and local investors.  

It will facilitate investment across the whole economy by supporting efforts to address challenges such as bureaucratic hurdles and regulatory uncertainty, which is especially relevant in sectors with untapped potential, such as renewable energy. For the first time in a SIFA, the agreement with Ecuador contains specific provisions which aim to deepen cooperation and facilitate investment in sustainable energy and raw materials - sectors of particular interest for EU investors and Ecuador. The SIFA is closely aligned with the EU's Global Gateway strategy in Ecuador, which supports investments and sustainable infrastructure in sectors such as energy, water sanitation, and waste management. 

The EU is a leading trade and investment partner for Ecuador, with the EU's FDI stock in the country reaching €9.1 billion in 2024. The sectors receiving the most EU foreign direct investment include construction, business services, transport, storage, communications, and manufacturing. 

Pursuing SIFAs is among the objectives set out in the EU's Competitiveness Compass, which highlighted the need to seek new ways of deepening partnerships and creating benefits for EU businesses. 

Next steps 

With its proposals for the signature and conclusion of the SIFA, the Commission is seeking the Council’s approval to sign the agreement. Once the Council gives its agreement it will be sent to the European Parliament for consent. Following approval, the deal can enter into force. 

For more information 

Commission proposals for Council decisions on the signature and conclusion of the EU-Ecuador Sustainable Investment Facilitation Agreement (SIFA) 

EU and Ecuador conclude negotiations for a SIFA  

EU-Ecuador trade relations 

On 11 September, the European Commission has put forward its proposals to the Council for the signature and conclusion of Free Trade Agreement (FTA) between the European Union and India, seeking authorization for its signature and conclusion. If authorized by the Council, this will be the largest trade agreement ever concluded by both the EU and India.

Once adopted and entered into force, the agreement will improve market access, reduce tariffs, tackle unnecessary barriers to trade, as well as provide predictable rules for trade and investment between the EU and India. The EU and India already trade over €180 billion worth of goods and services per year, supporting close to 800,000 EU jobs. This deal will eliminate or reduce tariffs on 96% of EU goods exports to India. Overall, the tariff reductions will save around €4 billion per year in duties on European products. It will make it easier for European companies to access the Indian market and compete on a more level playing field, while it will ensure consumers can benefit from increased choices and more competitive prices.

The proposal put forward today represents a key step towards ensuring that consumers and businesses can start reaping the benefits of this deal as soon as possible. This is in line with the fast-track procedure laid out by Commissioner for Trade and Economic Security, Maroš Šefčovič earlier this year. The procedure aims at speeding up the implementation of FTA's, which is crucial at a time of geopolitical uncertainty and growing pressure on the global trading system.

The EU-India FTA reflects the EU's commitment to strengthen economic ties with key partners in the Indo-Pacific region. With its proposals, the Commission is seeking Council's approval to sign the agreements which will then require European Parliament's consent, before conclusion and entry into force. The Indian authorities are in parallel going through their own internal ratification procedures.

For more information

Proposal for a Council Decision on the signing of the Free Trade Agreement between the European Union and the Republic of India

Proposal for a Council Decision on the conclusion of the Free Trade Agreement between the European Union and the Republic of India

Questions and answers on the EU-India Free Trade Agreement

Europe has plenty of world-class research, talent and creativity. However, too often ideas originating in Europe are turned into economic success by others, elsewhere. This is because European innovators face barriers here and find it difficult to bring their ideas to life. As a result, the Commission proposed a new European innovation act to help Europe's most innovative ideas be developed, financed and scaled up in Europe.

To strengthen the EU innovation system, the proposal will address two main challenges. Firstly, it will help innovative companies access financing by

• promoting a common EU framework to value intellectual property
• creating a digital marketplace connecting buyers and sellers of intellectual property
• offering expert support to help companies bring their ideas to the market

This can unlock €10.2 billion per year in additional financing and generate around €35 million in administrative cost savings.

Second, it will establish a common approach for research and development procurement that

• will provide greater legal certainty 
• help new technologies reach the market faster
• make it easier for public buyers from different EU countries to jointly carry out Research and Development procurements. 

With this, companies could expect €25.92 billion in additional annual profits, while public buyers could save €1 billion per year.

The European innovation act is an element of the competitiveness compass, to strengthen the EU's long-term competitiveness, prosperity and technological sovereignty. In parallel, the Commission will help innovators accelerate the transformation of innovative ideas into market solutions through a specific proposal on regulatory sandboxes.

For more information

Press release - Commission proposes new European Innovation Act to help innovative European ideas grow and compete globally

Questions and answers on the European Innovation Act

Factsheet on the European Innovation Act

The European Innovation Act

Hardware and software products are increasingly exposed to cyberattacks. From baby monitors and smartwatches to apps and computer programmes, products with digital elements are part of our daily lives. The Cyber Resilience Act (CRA) strengthens the cybersecurity of these products and better protects consumers and businesses from cyber threats.

As of 11 September 2026, manufacturers must report any actively exploited vulnerabilities and severe incidents that have an impact on the security of their products. They must submit an early warning within 24 hours, followed by a full notification within 72 hours. A final report must then be submitted no later than 14 days after a corrective or mitigating measure is available for an actively exploited vulnerability, and within 1 month for a severe incident. 

In practice, this means consumers can rely on faster notifications and stronger protection for their connected devices, such as door locking systems, keeping their home safe and secure in the event of a cyberattack. 

The reporting obligations apply to all products with digital elements made available in the EU, including those already on the market. Manufacturers will submit their notifications through the CRA Single Reporting Platform, established and maintained by the European Union Agency for Cybersecurity.

The Commission published practical guidance to help manufacturers, developers, and businesses meet their obligations. National market surveillance authorities will ensure enforcement of the rules. 

The Cyber Resilience Act builds on the EU cybersecurity strategy and the EU security union strategy. It aims to strengthen the EU approach to cybersecurity. The new rules require products with digital elements to be designed, updated, and maintained to protect users from security risks. The CE marking will help them identify products that comply with the CRA requirements. 

The main obligations introduced by the Act will apply from 11 December 2027, while the reporting obligations apply from 11 September 2026. 

For more information

Cyber Resilience Act

Protecting your digital life

ENISA - FAQ

Digital economy and society

The modern media disinformation chain is a slippery thing. A report alleging something nefarious appears here and, in just a day, lands on a major British paper there. And in a media environment that prioritizes speed above all else, establishing the facts of an allegation can be the difference between being first and being late…but right.

Take, for example, a recent story that’s been picked up in the British press about two lemurs being stolen from a Bangladeshi safari park. It began on 8 September when the outlet, Ajker Patrika, published a story claiming two ring-tailed lemurs stolen from the Gazipur Safari Park had been found in India at the wildlife sanctuary, Vantara.

Before diving into the details, any attentive reader of Ajker Patrika’s story would have flagged that the outlet repeatedly and inexplicably referred to the wildlife sanctuary as “Banatara”. To be clear, there is no Banatara, and such editorially wobbly standards should have been the first tip-off that the wider foundations of this story were placed on unstable facts.

But, obvious spelling errors aside, Ajker Patrika plowed forward and reported that the animals passed through intermediaries before reaching Jamnagar where they were, according to the Bangladesh’s Criminal Investigation Department (CID), sold to an institution associated with Vantara. The outlet said that investigators had linked them after seeing photographs of lemurs at Vantara, but simultaneously admitted that there were no identifiable markers capable of confirming that Vantara’s animals were, in fact, the stolen ones. Adding to the difficulty in identifying these lemurs as the stolen ones is the fact that, while wild ring-tailed lemurs are listed as endangered, captive-bred ones are some of the most popular species of lemur in zoos worldwide and can be legally sourced with ease.

Despite the absence of microchips, individual identification numbers, or stored DNA profiles capable of establishing a link, Ajker Patrika treated the sudden appearance of lemurs at Vantara as proof enough of wrongdoing. On September 9th, the story blew open when The Independent gave the allegation international credibility. The liberal-left paper repeated the claims that Vantara’s lemurs were the stolen ones while acknowledging that there was no hard proof over the animals’ true provenance. It even outright claimed its reporting was based on Ajker Patrika’sdetails of the events. No further Independent-led interview with the CID was held to confirm the location of the animals. Instead, the paper took the original, mercurial reporting from one Bangladeshi outlet, treated it as fact and even spun a more authoritative-sounding headline, claiming, “Bangladesh says two stolen lemurs have been taken to billionaire’s private zoo in India”.

Cue the maelstrom. At least a dozen outlets across several countries rehashed The Independent’s work, creating an echo-chamber amplifying allegations built on weak foundations and unexamined, second-hand reporting. Bizarrely, Ajker Patrika reported on The Independent’s reporting of its own story the very next day, saying the lemurs had been stolen, “according to a report by British newspaper The Independent, citing Ajker Patrika.” Circular amplification at its finest.

By September 11th, Bangladeshi authorities were working to set the record straight. Bangladesh’s widely-read The Business Standard quoted CID Special Superintendent of Police, Chufi Ullah, saying that while investigators had established the lemurs had been trafficked to India, they had not established where they subsequently went. He specifically went on the record to deny that the CID had said the animals were at Vantara.

For its part, Vantara has said it had no involvement in the theft and has received no notice from any investigating agency. It affirmed that the animals in its care are housed in accordance with Indian law with documented provenance and that it submitted records of its two ring-tailed lemurs. It also welcomed scientific verification, like a DNA test, to help

Despite the CID clearing up the central facts of the theft, The Independent and Ajker Patrika have yet to amend their headlines. Perhaps the damage is already done. In this media environment where speed matters more than facts, unverified information can reign, making the separation of truth from fiction more difficult than ever before.

The mayor of Albania’s capital city says he has “not lost hope” despite being held in detention for over 18 months.

Erion Veliaj (pictured) has remained nominally in office as mayor of Tirana despite being held in what is known as pre-trial detention (PTD) since February 2025.

He is accused of corruption and money laundering but strongly denies any wrong doing.

The latest, and arguably most significant, in a protracted series of court cases takes place on 15 September when his case will be reviewed by Albania’s Supreme Court.

This comes after the country’s Constitutional Court called for a review.

In a dramatic new twist, the jailed mayor has now written a letter from prison in which speaks of a “political persecution” being waged against him.

It is thought to be the first time the hugely experienced official has spoken directly to the media in what has been a protracted legal case.

In the letter, dated 8 September, he says it has now been 19 months that he had been held in what is known as “pre-trial detention”.

He points out that his continued detention is “without being sentenced.”

He goes on,  “Despite having won twice in the constitutional court the system is endlessly dragging its feet and delaying beyond reason my detention review despite the two constitutional court decisions.”

The Constitutional Court of Albania has issued two landmark rulings in favour of Veliaj, protecting his elected mandate and ordering a  a fresh review of his pretrial detention.

The court first overturned the Tirana Municipal Council's decision to dismiss Veliaj following his detention in February 2025 on corruption and money laundering charges.

In a second ruling in July the court annulled a Supreme Court decision upholding Veliaj's continued pretrial detention and remanded the matter back for a renewed review.

The constitutional court found that lower courts failed to properly evaluate the necessity and proportionality of keeping a democratically elected mayor in prison, or to weigh less restrictive alternatives against his constitutional duties and the rights of voters.

The letter by Veliaj addresses his continued detention for over 18 months, saying that the “delays alone is, in itself, a punishment for the citizens of Tirana too, not only for me and my family.”

“They too are being deprived of the right to be served by their democratically elected mayor.”

He continues, “Albania’s democracy has, thus, been sentenced without a court order, much like my friend Ekrem İmamoğlu in Istanbul.”

This is a reference to Ekrem İmamoğlu, the main political rival of Turkish president Recep Tayyip Erdoğan.

İmamoğlu was arrested in March 2025 and remains in pre-trial detention at Marmara Prison.

He faces charges including bribery and extortion but denies any wrong doing.

Turkey’s opposition leader has said the charges were intended to prevent İmamoğlu running for president in the 2028 election.

His arrest was met with outrage from the CHP and prompted demonstrations across Turkey.

In his letter,Veliaj states, “In December 2024 I had my last meal with İmamoğlu hopeful that the future would be brighter for our democracies, citizens and countries.”

He concludes, “We were wrong – the demise of local democracy will be a stain for both our countries. We have exchanged letters from jail and still have not lost hope.”

He says that his legal team have been refused permission to meet with him to prepare his appeal to the Strasbourg-based European Court of Human Rights, "without providing a reason."

Although it has naturally received a lot of publicity within Albania itself the case has remained largely under the radar outside the country. But international interest is now starting to grow with highly respected publications and media outlets running articles about it.

The local lawyer acting for Veliaj, who has regularly appeared in court with him, told this site, “The decision on September 15 is highly significant. The Constitutional Court overturned the Supreme Court’s decision because it had failed to adequately address and justify the proportionality of pre-trial detention—the most restrictive security measure—in relation to Erion Veliaj’s constitutional mandate.

“He could potentially be released on the 15th. Our view is that the Constitutional Court has already settled the key legal issues, providing a basis for his release. However, that outcome is not guaranteed and will depend on the court’s decision that day,” said the Tirana-based lawyer.

This website reached out to the Albanian authorities for comment on the case.

Ida Vodica, director of the Public, Media and Foreign Relations Directorate for the  Supreme Court, said, “I can confirm that the case concerning Mr. Erion Veliaj has been registered in the Supreme Court and is currently scheduled for 15 September 2026.

“The appeal (cassation) will be considered by the Criminal Chamber of the Supreme Court, in consultation room, sitting as a panel of three judges, in accordance with the applicable procedural rules.

“At this stage, no further comments can be provided regarding the merits of the case or the outcome of the proceedings.”

Albania itself is a leading front runner to join the EU, possibly as soon as 2030, and has been consistently praised by the EU for its ongoing efforts to introduce reforms seen as necessary for it to become the EU’s next member. But some fear ongoing issues with its judiciary may slow progress towards accession.

European Democratics, a pan European body, recently posted a statement on the case, adding that Albania’s Constitutional Court had overturned a Supreme Court decision and ordered a new review of his detention, “questioning its proportionality in light of his mandate as Tirana’s democratically elected mayor.”

European Democratics called on the Albanian authorities to “uphold the rule of law, the presumption of innocence and the principle of proportionality.

“We will keep the spotlight on it (the case), because Albania deserves a European future — one that is fully democratic, transparent and firmly committed to fighting corruption, while guaranteeing that justice is always exercised with fairness, independence and respect for fundamental rights.”

The case has also shed a light on the general use of pre trial detention.

On January 30, a joint letter was issued by the “B40 Balkan Cities Network” calling for an end to PTD. The letter calls PTD a “dangerous trend.”

The network promotes local democracy, sustainable development, and regional cooperation among Balkan cities.

Member mayors signed a joint solidarity letter addressing the pretrial detention of key figures, including Istanbul Mayor Ekrem İmamoğlu and Erion Veliaj.

The European Commission has put forward the European Radioisotope Valley Initiative (C/2026/6132) a new strategic framework to strengthen Europe’s leadership in the production of medical radioisotopes. It aims to reinforce EU security of radioisotope supply, guiding investment in the sector and reducing strategic dependencies on third countries, in particular Russia.  

With more than 10 million medical procedures using radioisotopes performed in the EU every year, mainly in oncology and cardiology, an impressive EU-wide production and distribution network has been developed to supply radioisotopes to patients across Europe daily. The EU has become the world’s leading producer of medical radioisotopes, exporting about half of its production overseas. However, critical parts of the European supply chain are exposed to dependencies on foreign suppliers, ageing production facilities, and competition from alternative suppliers, thereby creating the risk of investment displacement and higher costs. Furthermore, the global demand for medical radioisotopes, as well as the pace of innovation in this area, are increasing. Today’s ERVI communication responds to these challenges by defining a coordinated approach to supporting investments in research and development, bringing innovation to market, addressing value chain dependencies, and increasing production capacity. It also provides a direct contribution to the REPowerEU Roadmap towards ending Russian energy imports.

The Communication establishes five strategic priorities and 10 actions.

Research & Development and bringing innovations to market

The Commission will support research and innovation into the next-generation medical radioisotopes, radiopharmaceuticals and production technologies. A Strategic Research and Innovation Agenda (SRIA) - as used in other sectors - will help better connect research with market needs and patients. Instruments such as the emerging IPCEI for innovative nuclear technologies, the European Innovation Council, and new European partnerships can help mobilize public and private investment to accelerate innovation deployment. 

Investments in production facilities to ensure security of supply

The initiative aims to guide and support Member States and industry investments across the medical radioisotope value chain to strengthen the resilience and localisation of EU supply. Priorities include the development of EU-based metallic High Assay Low Enriched Uranium (HALEU) capacity and production of stable isotopes currently imported from Russia, as well as upgrades of existing reactors and construction of new production facilities. Member states should make use of the EU Startup and Scaleup Strategy, the SGEI State aid framework and the recent Critical Medicines Act for which the political agreement was achieved this year to support these efforts, while the Commission will explore ways to better combine public and private financing.

Market Monitoring and Forecasting

The Commission will act to improve the visibility of supply and demand trends and assess the investment needs of the European market for radioisotopes. This work will build upon the European Observatory on the Supply of Medical Radioisotopes and rely on continuing involvement of Member States and stakeholders, while making full use of the new EU mechanisms for tackling shortages of essential medicines.

Developing strategic international partnerships

ERVI will support cooperation with trusted international partners to diversify supply chains, strengthen resilience and promote scientific and industrial collaboration. In particular, the continuing cooperation with our partners in the UK and US is crucial for developing a resilient supply chain for metallic High Assay Low Enriched Uranium (HALEU).

Supporting an evolving regulatory framework

The Commission will cooperate with the International Atomic Energy Agency to support reliable international transport of medical radioisotopes and explore further measures to facilitate transport between Member States. A further step will be to pursue the streamlining of EU and national procedures for radiation protection and waste management in nuclear medicine to support patients’ access to innovative treatments.

Background

In June 2024, the Council called on the Commission to seek to maintain Europe’s global leadership role in the supply of medical radioisotopes and make tangible and swift progress on developing ambitious ‘building blocks’ for specific actions. 

In order to define the objectives and architecture of ERVI, the Commission carried out extensive consultations involving stakeholders and member states and published a feasibility study in March 2026.

The initiative also builds on the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA), adopted by the Commission in 2021 to strengthen the secure supply of medical radioisotopes, improve quality and safety in radiation medicine, and support innovation in nuclear medicine technologies.

In May 2025, the REPowerEU road map further highlighted the need to increase EU production capacities, reduce dependency on Russia and strengthen the resilience of the European medical radioisotope supply chain. The establishment of ERVI was identified as one of the roadmap’s key actions.

Related links

• Communication on the European Radioisotope Valley Initiative (C/2026/6132)
• European Radioisotope Valley Initiative
• ERVI feasibility study
• SAMIRA – Strategic Agenda for Medical Ionising Radiation Applications
• European Observatory on the Supply of Medical Radioisotopes

This consultation invites stakeholders to propose changes to the VAT rules so that they  better support circular business models. 

The European Commission has launched a consultation on the alignment of VAT rules with the principles of the circular and low emission economy. This initiative, part of the upcoming Circular Economy Act, aims to support the transition towards a more sustainable and competitive European economy.

The Circular VAT consultation seeks stakeholder input on how VAT rules can be adapted to better support circular business models. The focus will be on three key areas: the treatment of second-hand goods, the destruction of  viable goods, and the VAT deduction rules for passenger cars used for business purposes.

The consultation is part of a broader evaluation and impact assessment process, which will run in parallel and is expected to conclude in early 2027. The findings from this process will inform a legislative proposal aimed at amending the VAT Directive to better align with the objectives of the circular and low emission economy.

The consultation is open for eight weeks and will be accessible via the Commission's 'Have your Say' portal. Stakeholders, including business federations, SMEs, trade associations, national tax authorities, academics, and the general public, are encouraged to participate and share their views.

This initiative is a crucial step towards creating a more coherent VAT framework that supports the circular economy and contributes to the EU's environmental sustainability objectives.

Businesses, tax experts & sustainability advocates – share your views by 4 November 2026.

Have your say!