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News From Around The Industry

CenterWatch Weekly Features

FDA Seeks $100 Million for Real-World Databank

The FDA has asked Congress for $100 million to help build an advanced analytics system the agency says will help it, at long last, master real-world evidence.

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FDA Suggests Endpoints for Opioid Treatments

Sponsors may not have to prove a proposed therapy helps addicts totally kick opioids to win FDA approval. But they will have to show it significantly cuts dependence on the potent pain meds, the agency says in new draft guidance.

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Trial Results & Briefs

FDA: Focus on Hardest to Treat in Cohort Cancer Trials

The FDA says sponsors considering adaptive studies for early phase cancer treatments should focus on patients with no other options. The agency notes that so-called expansion cohort trials — which start out relatively small but expand if a potential treatment shows promise — can be a way to get a treatment to market more quickly.

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Vivitrol Helps HIV Patients Reduce Alcohol Intake

Monthly injections of the anti-addiction drug naltrexone (brand name Vivitrol) may help HIV-positive patients cut down on heavy drinking but it doesn’t help them stick to their med schedules, Yale researchers found.

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