Entries by Thomas Gabrielczyk

Spain again tops Europe in clinical trials

Spain has once again secured the top position in Europe for clinical trials. According to various Clinical Research Organisations at BioSpain 2025 (7–9 October, Barcelona), this is largely due to the speed with which the Spanish Medicines Agency (AEMPS) approves clinical studies.

BioSpain 2025 starts with new records

BioSpain 2025 opened in Barcelona, the capital of Catalonia, setting a new record for both visitors and exhibitors. During the inauguration, representatives from government and industry highlighted the leading role of biotechnology in building economic and environmental resilience in Spain and across the European Union.

FDA approves atezolizumab–lurbinectedin for ES-SCLC

The U.S. FDA has approved atezolizumab and atezolizumab with hyaluronidase in combination with lurbinectedin as the first and only first-line maintenance therapy for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after induction therapy with atezolizumab, carboplatin and etoposide.

Pharma Tariffs: US Government backtracks

After the surprising announcement of a 100% tariff on all prescription drugs imported into the United States, the US government appears to be backtracking. Within a few days, its trade policy stance towards the pharmaceutical industry has shifted fundamentally.

Biologics CDMO Rezon Bio leaves stealth mode

Rezon Bio has launched as a European contract development and manufacturing organisation (CDMO) for biologics. The new company has been created following the demerger of Polpharma Biologics into two independent companies.

Genmab swallows Merus in US$8bn deal

Danish Genmab A/S has acquired the Dutch oncology specialist Merus NV for US$8bn in cash. The 41% premium over Merus’s share price at Friday is largely attributed to the bispecific EGFR x LGR5 antibody, Petosemtamab

MSD Secures Option on EVX-B3

Danish Evaxion A/S hat optionally licenced its vaccine EVX-B3.developed with its AI-Immunology™ platform to Merck, Sharp & Dohme. MSD payed UIS$7.5m upfront and offers up to US$592m in milestone payments plus royalties on net sales.

Trump Targets Overseas with 100%-Tariff

Overnight, US President Donald Trump broke previous tariff agreements with the United Kingdom and the EU, announcing that from 1 October, patented medicines not produced in the US will be subject to a 100% tariff.

UniQure’s stocks up after AMT-130 trial win

Amsterdam-based UniQure NV’s stocks made a 240% after-hours jump at Nasdaq after the company announced its Huntington gene therapy AMT-130 met the endpoints of a Phase II study and it will apply for marketing authorisation next year. In addition, UniQure entered into a US$175m non-dilutive senior secured term loan facility with Hercules Capital and commenced a US$200m underwritten public offering of its ordinary shares to prepare a BLA in Q1 2026.