Obesity Drug Development To Be Discussed By Advisory Committee Sept. 8
This article was originally published in The Pink Sheet Daily
The Endocrinologic & Metabolic Drugs Advisory Committee will consider comments on FDA's obesity drug guidance which include reducing the number of subjects required to evaluate a drug's safety profile and broadening inclusion criteria.
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Agency also wants long-term studies on older drugs and combinations of approved therapies. FDA will hold an advisory committee meeting to discuss potential changes to its 1996 draft guidance on weight-loss drugs.
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.