Clinical research
The Phase 2 study was small and was not designed to establish the statistical difference between Vistagen’s drug candidate and placebo, according to Vistagen. The biotech plans to meet with the FDA to determine a registrational path for the asset.
BioVie’s stock fell by nearly 50% as the biotech claimed victory in a mid-stage Parkinson’s disease trial using an alternative endpoint to the primary clinical goal.
In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
Strong quarterly results are prompting Bristol Myers Squibb to lift its 2026 outlook, though the company is facing another delay for key Cobenfy Alzheimer’s data and a pushed-back readout for milvexian.
In this episode of Denatured presented by Arvinas, Jennifer Smith-Parker speaks to Arvinas President and CEO Randy Teel about the strategic discipline and leadership required to successfully refocus a company on an early-stage pipeline after a lead asset is outlicensed, discontinued or otherwise falls away.
Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?
Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.
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