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Call for greater investment and innovation from pharma to address RSV
Despite progress from AstraZeneca, Sanofi, Merck & Co, GSK and Pfizer, analysts say effective respiratory syncytial virus treatments are still needed.
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Clinical Development
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J&J’s Tremfya secures two paediatric psoriasis approvals from FDA
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
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Genmab makes $8bn acquisition to boost late-stage antibody therapy pipeline
The deal will support the biotech in its plans to advance bispecific antibody petosemtamab in multiple oncology indications.
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One-time gene therapy could “transform” Huntington’s treatment landscape
uniQure’s positive topline data “are the most convincing in the field to date” and indicate the gene therapy’s potential disease-modifying effects.
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Bayer claims cell and gene therapy first in Parkinson’s research
Advances cell therapy and gene therapy candidates, with both showing neurorestorative potential against the disease.
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Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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European Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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Roche pays $3.5bn for 89bio and its potential best-in-disease treatment MASH drug
The deal with the US biopharma could help address metabolic dysfunction-associated steatohepatitis, one of the most prevalent comorbidities of obesity.
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Novartis builds on Monte Rosa collaboration with $5.7 billion deal
Expanding its collaboration with the US biotech will add novel molecular glue degrader-based medicines to the pharma company’s pipeline.
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FDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
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Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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FDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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MHRA pilot to prepare sponsors for clinical trial regulation changes
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
