Clinical research

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.
FDA
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.
With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year.
In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging trajectories of Nordic biotech and what it will take for the region, including Norway and Finland, to compete more cohesively on the global stage.
This webinar provides an assessment of recent job market activity across biopharma and explores how companies approaching commercial readiness or building out sales and marketing teams can navigate today’s hiring trends.
PRESS RELEASES