As the regulatory strategy becomes a boardroom-level concern for biotech executives pursuing global expansion, knowing how the Saudi Food and Drug Authority (SFDA) and the European Medicines Agency (EMA) differ is crucial, particularly as Saudi Arabia accelerates its ambition to become a global life sciences hub. Although both regulators adhere to international norms, their differences in review speed, procedural flexibility, and strategic positioning can have a direct impact on competitive advantage, investment planning, and time to market.
Genethon licenses core AB-1009 technology to AskBio after IND clearance
Latest NewsFrench gene therapy research institute Genethon announced it has signed an exclusive global license with AskBio that allows the company to use Genethon-patented technology incorporated in AB-1009, an experimental gene therapy for Pompe disease.
EMA and FDA join forces: Aligned principles on AI use in drug development
Latest NewsThe European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have together compiled ten principles for good artificial intelligence (AI) practice in drug development.
With a €6.26M round, QLi5 doubles down on proteasome-based ADC payloads
Latest NewsQLi5 Therapeutics has completed a €6.26 million capital increase led by its Korean co-founder, Qurient, which has also increased its voting stake in the German biotech. The funding will be used to advance QLi5’s proteasome inhibitor(PI)-based antibody-drug conjugate (ADC) payload platform, an approach the company is presenting as a next step beyond today’s dominant ADC payload classes.
Novo Nordisk Foundation commits DKK 5.5 billion to scale European biotech innovation
Latest NewsThe Novo Nordisk Foundation has committed up to DKK 5.5 billion (€736 million) to the BioInnovation Institute (BII), a Copenhagen-based hub for life science and deep tech entrepreneurship. The long-term funding, running from 2026 to 2035, aims to strengthen Denmark’s innovation capacity while helping Europe turn scientific excellence into companies, jobs and solutions.
Return as new Chief Financial Officer
AppointmentsJurgen Berendsen has returned to Symeres (Nijmegen, NL) as Chief Financial Officer. His appointment took place at the beginning of this year.
Munich’s Innovative Molecules signs €125M partnership with Alfasigma to advance HSV encephalitis antiviral
Latest NewsMunich-based Innovative Molecules steps into the spotlight with a partnership with Italy’s Alfasigma. The deal brings fresh capital and a global licence for adibelivir, a next-generation antiviral targeting the ultra-rare, life-threatening Herpes Simplex Virus (HSV) encephalitis.
Faster to the bedside: Collaboration in cell therapy of Fresenius Kabi and TQ Therapeutics
Latest NewsFresenius Kabi and TQ Therapeutics have entered into a strategic development agreement in cell and gene therapy. Fresenius Kabi receives an exclusive licence to develop, manufacture and distribute products incorporating TQ’s cell selection technology. The aim is to enable more scalable, efficient cell therapy production and broader, more cost-effective patient access.
SFDA vs EMA: What Biotech Leaders need to Know
slider, Sponsored PublicationsAs the regulatory strategy becomes a boardroom-level concern for biotech executives pursuing global expansion, knowing how the Saudi Food and Drug Authority (SFDA) and the European Medicines Agency (EMA) differ is crucial, particularly as Saudi Arabia accelerates its ambition to become a global life sciences hub. Although both regulators adhere to international norms, their differences in review speed, procedural flexibility, and strategic positioning can have a direct impact on competitive advantage, investment planning, and time to market.
2026: A year of reckoning for BioNTech
Latest NewsFor BioNTech, 2026 could become one of the most decisive years since its pandemic-driven breakthrough. The pipeline is broad, the coffers are well stocked, partnerships are numerous, and the outlook extends far beyond 2030. Yet despite all the strategic preparation, one key question will be answered in the coming months: can the clinical data live up to the high expectations surrounding BioNTech’s cancer strategy?
Eli Lilly-Abivax €15 billion takeover rumor stirs markets, but no formal steps confirmed
Latest NewsWhile much of the biotech industry is focused on meetings and dealmaking at the J.P. Morgan (JPM) Healthcare Conference, a rumor has cut through the JPM noise. The possibility of Eli Lilly making a move on Abivax is back on the table, with a price tag that would imply a valuation close to twice the French company’s current market capitalisation at €8.4 billion ($9.8 billion).