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In this episode of Denatured, you’ll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients.
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From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace’s NextGen Class of 2026 told us about the issues keeping them up at night.
Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s.
Poplar Therapeutics is seeking a “step change” in the treatment of food allergy and other atopic conditions, with $95 million raised to date, including a $45 million series A extension that closed Tuesday.
OSE Immunotherapeutics has kicked off a strategic realignment initiative that involves deprioritizing the AbbVie-partnered OSE-230 and focusing its resources on the late-stage development of its ulcerative colitis candidate lusvertikimab.
The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker levels or neurodevelopmental outcomes.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decision-making, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.
Less than a year after cutting roughly 30% of its employees, BioAtla is letting go of an even larger chunk of its workforce as it considers its future, which could include strategic partnerships and selling off assets.
Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.