U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.

The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.

Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.

DNA damage response specialist Artios Ltd. has closed an oversubscribed $115 million series D after delivering positive phase I/IIa data for its two lead programs.

Fresh cash infusions are on the way for European biotech after two leading venture capital firms announced large new funds. Asset-focused Medicxi has closed an oversubscribed €500 million (US$580 million) fund, while Sofinnova Partners exceeded its target of €500 million to close its Capital XI fund at €650 million (US$753.5 million).

Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.

Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.

Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.

The industry has been complaining about the drug pricing and reimbursement policies of European governments for years, but only now with the Trump administration’s moves to enforce most favored nation (MFN) pricing and reduce the U.S./EU price gap are governments facing up to the reality that they will have to pay more for new drugs.

Pfizer Inc. emerged over the weekend as the winner of the bidding war for Metsera Inc., with the two reaching an amended agreement after market close Nov. 7 that values the obesity drugmaker at about $10 billion. The next day, the other contender, Novo Nordisk A/S, confirmed it does not intend to increase its most recent offer.