About DIPHTHERIA

The early work on the organism and the toxoid vaccine reads like the ‘Who Is Who’ of microbiology: Klebs, Loeffler, Koch, Roux, Yersin, Behring, Kitasato, Schick, and T. Smith were all involved in bringing this deadly disease under control. In those days bacteria and diseases were referred to by the Continue reading About DIPHTHERIA

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?