Infectious Diseases

Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

Moderna will pay $950m upfront under the settlement, which lifts a significant weight off its shoulders, as investors had feared it could be on the hook for $5bn.

The European Medicines Agency said that Acoziborole Winthrop would simplify the treatment of first- and second-stage disease caused by Trypanosoma brucei gambiense.

The drugmaker presented Phase III data at CROI showing the two-drug combination pill is non-inferior to existing options like Gilead’s Biktarvy, both in treated and untreated HIV patients.

Gilead anticipates that the single-pill combination’s novelty will make it an attractive new option for patients already virologically suppressed.

The company announced updated data showing superiority for the long-acting injectable over daily pills among patients with adherence challenges.

Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.

The company reported continued growth for its HIV franchise in 2025, while oncology sales declined as Gilead’s cell therapies continued to slump.

Scrip spoke with CMO Dietmar Berger about his views on diversifying Gilead’s virology, oncology and immunology R&D efforts through both in-house research and external innovation.

At a recent discussion in South Korea, CEPI and other participants explored ways to discover new health cooperation models that go beyond traditional aid approaches and to strengthen Korea’s role.

SK bioscience jumps into RSV preventive antibody space through new Gates alliance.

A CEPI-supported partnership between MSD Hilleman and SK bioscience aims to improve Ebola vaccine manufacturing and supply.