Drug Development
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
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The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
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Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
The layoffs come as the company posts nearly $300 million in net losses and just over $80 million in revenue during the first quarter of 2023.
The deal with BlissBio is the latest in a cascade of multi-million- and billion-dollar acquisitions and collaborations centered on antibody-drug conjugates.
The German biotech is trying to deepen its pipeline in cancer and other infectious diseases as COVID-19 markets contract and the international public health emergency comes to an end.
After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.
The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome.
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.