Phase III Melanoma Trial Design For Vical’s Allovectin-7 Expected By Year-End
This article was originally published in The Pink Sheet Daily
However, an FDA warning letter to a clinical investigator in a Phase II high-dose trial of the gene therapy could complicate the company’s efforts to reach an agreement with the agency on trial design. The agency cited an Illinois researcher for protocol violations.
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Italy claims to have pushed farther into managed entry agreements than other European countries with strong clawback provisions on new drugs – particularly cancer drugs – if they don't work as well as their manufacturers claim. The financial clawbacks are supported by extensive outcome data collection across the country's twenty regions.
The U.K.’s Health and Social Care Bill was introduced into Parliament on Jan. 19, offering a new commercial landscape best navigated by pharma through bolstered relationships with general practitioners.
Companies will share data from the proof-of-concept study, but they do not intend to commercially pursue the use of both drugs in combination.