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.
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).
New COO takes over
AppointmentsCambridge-based techbio company Qureight Ltd has appointed Rebecca Simmons as its new Chief Operating Officer in January.
bit.bio closes a $50 million series C round after its 2025 restructuring
Latest Newsbit.bio has raised $50 million in a series C round led by M&G Investments to support the next phase of its human cell programming business. The Cambridge-based company develops defined human cells using its opti-ox technology, supplying reproducible cell types to researchers and drug developers for use in drug discovery.
Second time around: Roche’s return to MediLink underlines the value of the first deal
Latest NewsRoche is back in China — and this time at a very different price point. In a renewed partnership with MediLink Therapeutics, the Swiss pharmaceutical group has secured a second antibody–drug conjugate (ADC), underlining how the first collaboration has paid dividends for both sides.
Numab’s billion-dollar antibody deal takes an unexpected turn
Latest NewsJust over a year and a half ago, Swiss biotech Numab AG, based in Horgen on Lake Zurich, made the headlines when it sold a single antibody to Johnson & Johnson for US$1.25 billion via a spin-out vehicle. No back-loaded milestones, no future contingencies — but cash up front, as one might say, straight into the pocket.
Better late than never: Bayer eyes a slice of the mRNA vaccine pie
Latest NewsPatent disputes are part of everyday life in pharma. What is unusual is the timing. More than three years after the peak of the Covid-19 pandemic, Bayer has launched a broad patent offensive against the makers of mRNA vaccines – just as the market has cooled and the pandemic feels firmly in the rear-view mirror. Understandable from a financial perspective, perhaps, but still raising questions about the timing.
Enodia Therapeutics raises €20.7m seed round for targeted protein degradation pipeline
Latest NewsParis-based start-up Enodia Therapeutics has secured €20.7 million in seed funding to advance its early-stage pipeline of targeted protein degradation. Elaia, Pfizer Ventures and Bpifrance led the Seed financing under the InnoBio investment framework, with further contributions from Wallonie Entreprendre, Argobio Studio, MACSF, the Institut Pasteur, InvestSud, Sambrinvest and Mission BioCapital.