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GW Pharmaceuticals’ cannabis-based Lennox-Gastaut syndrome treatment Epidiolex shined in a Phase 3 trial, reaching its primary endpoint of a significant reduction in the monthly frequency of atonic seizures compared to a placebo over a 14-week treatment period. Read More
House Republicans have rolled out a broad proposal to replace the Affordable Care Act that includes several measures to streamline drug development. Read More
The FDA and the European Medicines Agency have formed a new working group focusing on incorporating patient perspectives into drug development, evaluation and post-marketing activities. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More