Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.

With the advent of 2023, comes the start of the industry’s next patent cliff, with five products that reached billions in sales at their peak set to lose US patent exclusivity during the year. Scrip takes a look into how the affected big pharma firms are preparing for anticipated market erosion and which generic and biosimilar companies are positioned to benefit the most.

Based on a new report by the Wharton School, this article tackles criticisms against the intermediaries that connect buyers and sellers, the GPO and PBM. It also analyzes the existential threats facing these intermediaries such as 'safe harbors', threats of disintermediation, and the consolidation of suppliers.

The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.