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Yochanra® approved in China as world-first for FGFR inhibitor-resistant cancer
This approval offers a potential new treatment approach for acquired resistance to FGFR inhibitors in advanced cholangiocarcinoma.
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NewsSanofi’s MenQuadfi approval expanded to infants from six weeks in Europe
Broader indication boosts protection against invasive meningococcal disease across a wider paediatric population in the EU.
NewsBioNTech appoints Guido Oelkers as new Chief Executive Officer
German biotech’s incoming leader set ahead of its goal of having multiple approved products by 2030.
NewsWHO proposes regulatory recommendations to support pharmaceutical decarbonisation
United Nations agency calls for coordinated action across the pharmaceutical value chain to align with existing regulatory practices that aid sustainable medicine innovation.
NewsTerahertz spectroscopy and machine learning accelerate API analysis
A new analytical approach combining terahertz spectroscopy with machine learning could support faster, non-destructive monitoring of active pharmaceutical ingredient content.
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J&J wagers on next cell therapy frontier with $2.6bn Sail Bio acquisition option
In vivo-focused collaboration has scope to considerably boost therapeutic innovation and address unmet need in immune-mediated diseases.
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GSK to relocate UK R&D centre from Stevenage to Cambridge
Investment provides significant growth opportunity for UK’s life sciences sector and in shaping the country’s research and manufacturing footprint.
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CHMP backs Roche’s Susvimo as first continuous nAMD therapy
Committee’s positive opinion supports a new, less burdensome treatment option for patients with the leading cause of vision loss in individuals over 60 years old.
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GLP-1 nutraceutical enables weight loss while preserving muscle mass, clinical data shows
Natural GLP-1 activator brings a differentiated approach to synthetic GLP-1 receptor agonists in the increasingly competitive obesity drug market.
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FDA warning letters highlight contamination control and facility maintenance failures
Findings from sterile drug manufacturing sites emphasise the agency’s expectation for companies to provide tangible evidence showing reduced quality and microbial risk and maintenance of control.
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BeOne Medicines commits $300m to expand New Jersey manufacturing
Facility expansion combines biologics and small molecule drug product manufacturing under one roof to accelerate its haematology and oncology pipeline.
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MHRA approves first HFA-152a propellant pMDI inhalers
Authorisation of Chiesi’s next-generation propellant signals a significant step in the pharmaceutical industry’s efforts to decarbonise respiratory medicine.
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FDA approves MSD’s Lipfendra as first oral PCSK9 inhibitor
Regulatory win facilitates the growing market demand for peptide therapeutics.
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Eli Lilly bets $2.8bn on AtaiBeckley’s psychedelic therapies for depression
AtaiBeckley’s lead asset addresses synaptic connectivity rather than neurotransmitter levels, as targeted by traditional antidepressants.
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Ph. Eur. revises general chapter on alternative microbiological methods
The updated general chapter 5.1.6 provides a modernised text intended to streamline implementation for users.
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Sandoz reshapes leadership to capitalise on biosimilar golden decade
New appointments will drive manufacturing efficiency in Sandoz’s generics business and merger and acquisition activities globally.
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AstraZeneca licenses novel oral EGFR inhibitor for $1.5bn
Agreement with Dizal Pharmaceutical gives the pharmaceutical giant access to the only approved oral targeted therapy for EGFR exon 20 insertion NSCLC in both the US and China.