Draft FDA Guidance for COCCIDIOIDOMYCOSIS

David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”.  He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS

HANSA, Where is the Beef?

Hansa is a small Swedish company with a unique product, a protease from Strep. pyogenes that cleaves IgG called Imlifidase, Idefirix or IdeS for short. They steered IdeS through a difficult early development, obtained approval for their drug in many EU countries for ‘desensitisation treatment of highly sensitised adult kidney transplant Continue reading HANSA, Where is the Beef?

OLOROFIM in a TIGHT SPOT

Regulatory and development status of Olorofim, a novel antifungal. Continue reading OLOROFIM in a TIGHT SPOT