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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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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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Varoglutamstat, a drug developed by German biotech Vivoryon Therapeutcs, did not hit its primary and secondary endpoints in a Phase IIb study in Alzheimer’s disease.
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease.
The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.
Exosomes show potential to treat myriad conditions, including cancer and inflammation, but experts are divided on whether the therapies are ready for the limelight.
As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
Pfizer’s oncology strategy to build up its biologics portfolio and dramatically reduce small molecules was influenced by the Inflation Reduction Act’s drug price negotiation provisions.
New 96-week data show Akero Therapeutics’ efruxifermin can improve fibrosis by at least one stage without metabolic dysfunction-associated steatohepatitis worsening in more patients versus placebo.
Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.