Press

• The conference programme will address the sector's major challenges, from advanced therapies and artificial intelligence to the bioeconomy and innovation financing.
• From 29 September to 1 October, the event will bring together companies, researchers, investors and institutions from more than 30 countries.
• Exhibition space remains available, offering a key platform for fostering strategic partnerships and new business opportunities.

• The European regulatory framework for genetically modified microorganisms (GMMs) is undergoing an update to keep pace with scientific and technological advances.
• In this context, the European Commission presented a legislative package in 2025 to modernise this regulatory framework. The process has now moved forward with the Council of the European Union adopting its negotiating position on the proposed Directive amending the legislation governing the deliberate release into the environment and the placing on the market of GMMs.
• AseBio believes the reform is moving in the right direction, while calling for regulatory ambition to be maintained throughout the negotiations in order to strengthen European innovation and competitiveness.

• Around 60% of human infectious diseases originate in animals. Climate change and globalization are reinforcing the need to improve prevention.
• In this context, biotechnology must be recognized as a strategic sector, as greater preparedness and stronger collaboration enhance our ability to anticipate and respond to future public health emergencies.
• On World Zoonoses Day, we spoke with HIPRA, one of the European biotechnology companies most strongly committed to the One Health approach.

• Biotechnology is driving new strategies to combat ALS, including research on the TDP-43 protein, a key target involved in the majority of cases of the disease.
• Molefy Pharma, an AseBio member company, is developing AP-2, an experimental therapy for ALS aimed at restoring the function of the TDP-43 protein. The company has already received orphan drug designation from the EMA and authorization from the Spanish Agency for Medicines and Medical Devices (AEMPS) to begin clinical trials in humans.
• “Today, ALS can be defined as a TDP-43 proteinopathy, that is, a disease of the TDP-43 protein,” says Alfonso de Egaña Barrenechea, CEO of Molefy Pharma.

• We have contributed to the Fraunhofer Institute’s technical questionnaire on the Biotech Act II, the European Commission’s public consultation on this forthcoming legislative initiative, and the feedback process for the Food & Feed Safety Simplification Omnibus.
• The success of the Biotech Act II will depend on its ability to transform Europe’s scientific excellence into investment, industrial capacity, and market-ready products through adequate funding and a simpler, more harmonized regulatory environment.
• Through our contributions to the Food & Feed Safety Simplification Omnibus, we advocate for regulatory simplification that provides legal certainty, reduces fragmentation among Member States, and facilitates the market entry of new biotechnological solutions.

• In 2024, the activity of biotech companies in Spain generated more than €13.27 billion in income, representing 1.2% of the national GDP.
• Investment in R&D by the biotechnology sector increased by 13.9%, reaching €1.46 billion.
• The number of biotech companies in Spain grew to 1,119 in 2025, representing a 10.4% increase compared to the previous year.
• In addition to the sector’s key indicators, the 2025 AseBio Report addresses the development of the Biotech Act and analyses the proposed regulation that will define the European biotechnology framework in the coming years.

• Biotechnology is redefining the approach to multiple sclerosis through new therapeutic tools, a more precise understanding of the underlying immunological mechanisms, and strategies aimed not only at controlling relapses but also at slowing the progression of neurological damage. 
• Sanofi, an AseBio member company, has made this area a strategic priority within neuroscience, with a research focus on chronic neuroinflammation and its role in disease progression. 
• Spain holds a leading position in this field, with renowned neurologists and hospitals that have extensive experience in multiple sclerosis and are highly active in international clinical research. 

From AseBio, we organized the panel entitled ‘European Biotechnology Act: an opportunity to consolidate Spain as a hub for biotechnological innovation’, within the framework of the XIX Annual Conference of Biomedical Research Technology Platforms, held in Barcelona.

• We welcome the overall regulatory proposal, but believe it requires greater ambition, specificity, and implementation capacity.
• We advocate for a Biotech Act I that genuinely improves access to funding, supports industrial scale-up, and delivers a more agile and harmonised regulatory framework so that biotechnology innovation can thrive in Europe.
• AseBio has actively participated in the development of the Biotech Act I, conveying the perspective of the Spanish biotechnology sector both in Brussels and to key national public administrations.