Life Science - Healthcare News | July 2025

Medtech: Medical Device Regulation Optimization Takes Concrete Shape

Reforms to the European Union (EU) Medical Device Regulation (MDR) are taking concrete shape. Introduced in 2021, the MDR legislation has attracted a number of criticisms including the shortage of notified bodies available to certify according to MDR stipulations. Medical technology manufacturers seeking to sell in the EU are required to declare CE conformity to EU legislation. In March, the EU Commission confirmed plans to revise the existing MDR framework in terms of bureaucracy, complexity, long terms and high costs as well as the aforementioned operations of recognized notified bodies. Of particular importance to companies active in Germany are special regulations for small-series products and fast-track procedures for care-relevant innovations. The measures to improve notifying body processes and performance are expected to come into being in Q3/25. 

Pharma: Bundesrat Gives Green Light to Binding Standard Contracts for Clinical Trials

Germany’s Bundesrat has approved a regulation introducing binding standard contractual clauses for clinical trials. These clauses are intended to accelerate contract negotiations, strengthen Germany as a location for clinical research, and improve healthcare provision. The Federal Ministry of Health still needs to formally issue the regulation. An alliance platform made up of pharmaceutical companies, university hospitals and research institutions has welcomed the planned regulation. 

Pharma: BioNTech and Bristol Myers Squibb Announce Billion Dollar Deal, BioNTech Acquires CureVAC NV 

German biotech company BioNTech has announced plans to collaborate with US pharmaceutical concern Bristol Myers Squibb to bring the experimental cancer drug BNT327 to market. The global co-development and co-commercialization agreement will accelerate the development of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. The clinical candidate is currently being evaluated in multiple ongoing trials including global Phase 3 trials for the treatment of small cell lung cancer and non-small cell lung cancer. A global Phase 3 trial evaluating BNT327 in triple negative breast cancer is planned for the end of the year. Bristol Myers Squibb will pay BioNTech USD 1.5 billion as well as USD 2 billion in non-contingent anniversary payments through 2028, with BioNTech eligible to receive up to USD 7.6 billion for additional development, regulatory and commercial milestones. In other news, BioNTech announced to acquire  Tübingen-based CureVac NV as part of a public exchange offer valued at over USD 1 bn. The acquisition will strengthen the Mainz-based concern’s research, development, manufacturing and commercialization of mRNA-based cancer immunotherapy candidates. 

Pharma: VERAXA Biotech Takes Milestone Step Toward NASDAQ Listing 

Heidelberg-based VERAXA Biotech has taken an important step on its journey to become a publicly listed NASDAQ company. The company, active in the research and development of next-generation antibody-based therapeutics for the treatment of cancer, has filed an F-4 registration with the US Securities and Exchange Commission. VERAXA plans to go public through a merger with Voyager Acquisition Corp., a special purpose acquisition company, with the deal valuing the company at more than USD 1.6 billion as a result of its oncology market potential. The registration contains key information about VERAXA’s drug development pipeline, technology platform, licensing partnerships, intellectual property, and research and development program. 

Digital Health: Amboss Completes EUR 240 Million Funding Round 

Berlin-based medtech company Amboss has completed a funding round valued at EUR 240 million. The company’s medical education and clinical decision-making platform, often described as being like a specialized “ChatGPT” for the healthcare sector, currently has over one million users in more than 180 countries. The new round with long-term investors will support the company’s international market expansion plans and provision for nursing staff and other healthcare professionals. 

Digital Medtech: Clinomic Secures EUR 23 Million in Series B Round 

Clinomic, a medtech company based in Aachen, has secured EUR 23 million in a Series B funding round. The cash injection has been made by the Deep Tech & Climate Fund and a private family office. Established as a RWTH Aachen University spin-off in 2019, the company specializes in intelligent assistance systems for hospital intensive care units. Clinomic’s “Mona” core product uses AI and speech processing to analyze medical information to support hospital workflows.

Digital Health Hub Nuremberg/Erlangen Secures EUR 30 Million for ZOHO Factory

The Zollhof Tech Incubator located in the Digital Health Hub Nuremberg/Erlangen has been awarded “EXIST Startup Factory” status as part of a competition run by the Federal Ministry for Economic Affairs and Energy. The start-up and technology center for digital ventures in Nuremberg was one of 10 lucky start-up factory status recipients. As a result, the Zollhof will receive EUR 30 million funding and a VC fund established with the creation of the “ZOHO Factory.”