Press

• 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.

• The Bilbao Exhibition Centre will host the next edition of BIOSPAIN from September 29 to October 1.
• Under the slogan “Bioinnovation that clicks,” the congress will feature a program focused on health, bioeconomy, and digitalization, with national and international experts, as well as keynote speakers such as Juan Bueren, who will discuss the sector’s major strategic and technological challenges.
• The congress will serve as a key platform for networking and generating business opportunities, with the participation of international investors. The final day will be dedicated to Talent Day, fostering connections between students, researchers, and companies.

• The event, organized by AseBio and the Salamanca City Council, was held this Tuesday at the Congress and Exhibition Center of the Tormes capital. It brought together 120 attendees from 75 organizations across five countries, as well as eight investment entities.
• The program has provided a global overview of the challenges and opportunities in food innovation, foodtech, and green biotechnology, with the participation of various stakeholders who analyzed how to drive the development and application of new solutions.
• It has also offered a space for generating new business and investment opportunities, thanks to its partnering platform, which enabled nearly one hundred bilateral meetings.

• According to WHO and ECDC data, 161,569 cases were reported in 2024 across 51 of the 53 countries in the European region, equivalent to 17.2 cases per 100,000 inhabitants.
• One of the main challenges is the diagnosis gap: it is estimated that nearly one in five tuberculosis cases in Europe goes undetected.
• In this context, MTBVAC, a tuberculosis vaccine candidate under development, is in an advanced stage of clinical development, and its potential approval could represent a significant breakthrough in the fight against tuberculosis.