The radiotherapeutics sector is attracting a new and diverse group of biopharma players hoping to capitalize on the potential advantages offered by newer therapeutic radioisotopes.
A new generation of radioactive drugs is heating up the lukewarm radiotherapeutics sector with isotopes that target diseased tissue without harming healthy cells.
Products in the pipeline appear potent at killing tumors while being unaffected by cellular resistance mechanisms. They have radioactive half-lives that are convenient for logistics or patient administration, and are...
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
