Vaccines

Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.

Faced with going out of business after repeated Phase II fails in a variety of tumor types for its investigational universal cancer vaccine, Norway’s Ultimovacs has been saved by compatriot Zelluna.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The Norwegian biotech is losing a big pharma partner and up to half of its staff, but remains confident about the prospects for its personalized cancer vaccine programs.

Yuhan eyes successors to lazertinib after US approval, leadership dispute at Hanmi drags on and SK Bioscience completes CDMO acquisition.

Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.

Sales of Arexvy fell back in the third quarter but GSK’s leadership believes the vaccine and several pipeline drugs can help the company achieve higher growth.

China gets more complicated as multinational drug makers venture deep into it. Even with a local savvy business partner, Merck is learning to navigate through fast-shifting market dynamics amid policy changes, consumer perceptions of foreign brands, and competition from local firms as it takes stock of its market access, pricing and life cycle management strategies.

Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared.

The FDA’s vaccine advisory committee endorsed a new plan to update pandemic influenza vaccines “inter-pandemic,” but encouraged the agency to consider how to make the approach feasible for novel vaccine technologies.