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Predictive stability modelling promising tool for optimising moisture-sensitive formulations
Research provides a data-driven foundation for excipient selection in drug formulation development, particularly solid dosage forms.
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NewsJohnson & Johnsonâs Caplyta demonstrates phase III promise for depression
Combination therapy comprising of an antidepressant and small molecule drug significantly boosted remission rates in adults with major depressive disorder.
NewsChemical assessment in Europe to be streamlined under new legislation
The European Commissionâs new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
NewsEndotoxin testing milestone reached with European Pharmacopoeiaâs animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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CARsgen wins first global approval of CAR T therapy for solid tumours
Approval of the autologous cell therapy satri-cel in China fills the gap in later-line treatment for advanced gastric cancer.
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Paulo Fontoura to lead research and development at Sanofi
Taking over from Dr Houman Ashrafian, the 25-year industry veteran will help to advance the firmâs innovation strategy.
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Biogen acquires immunology start-up RayThera for $1bn
Anti-inflammatory assets in the deal allow Biogen to expand immunology pipeline into new disease areas.
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FAP-targeted radiopharmaceuticals potential as next-gen treatment for multiple cancers
Innovative radiopharmaceuticals demonstrated âhighly promisingâ survival benefit in study of participants with end-stage solid tumours.
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Sandoz prepares for biosimilar âgolden decadeâ with new development centre in Slovenia
Opening of the new site represents the largest biosimilar development hub and supports Sandoz in building its in-house capabilities.
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Recipharm makes major investment to expand US sterile manufacturing footprint
Decision strengthens the CMDOâs fill-finish operations and increases capacity for biologics and advanced therapies.
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MHRA green lights lower dose EURneffy nasal spray for children
Needle-free allergy adrenaline treatment expands options beyond injection for younger UK patients for first time.
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Petri dish study could enhance accuracy of microbiological testing
Findings may help mitigate moisture-related issues when using Reasonerâs agar (R2A) during microbial water quality testing.
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MHRA targets medicine safety with new AI sandbox
Agencyâs new AI initiative will provide an evidence-based programme to encourage pharmaceutical companies to invest in innovation in the UK.
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GSK advances oncology efforts with $10.6bn Nuvalent acquisition
Multi-product oncology deal accelerates GSKâs entry into lung cancer.
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Gilead-MSD once-weekly oral HIV regimen meets Phase III endpoints
Combining islatravir/lenacapavir could provide alternative to daily antiretroviral therapy for virologically suppressed patients with HIV.
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Roche and Nurix to advance potential best-in-class BTK degrader bexobrutideg
Collaboration agreement expands Rocheâs oncology pipeline and offers therapeutic potential across immunology and neurology.
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Amgenâs Imdylltra approved in Europe for aggressive solid tumour
Milestone authorisation represents the first T-cell engagement therapy for small cell lung cancer.
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CorrectSequenceâs base-editing therapy shows preliminary success in sickle cell disease
Achievement of studyâs primary efficacy endpoint positions therapy as potentially safer and more effective approach to CRISPR-based gene-editing therapies.
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EU Commission issues plan to replace animal testing in chemical safety assessments
Publication marks a significant step towards modernising chemical safety assessments in Europe.
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Biologics growth expected to reshape pharmaceutical packaging demand
Evolving regulatory requirements and ensuring product sterility and stability are driving demand for packaging innovation, particularly for biologic medicines, research suggests.
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Lilly licenses Hanmiâs GLP-2 biologic sonefpeglutide for $1.2bn
Agreement to develop and commercialise long-acting GLP drug candidate by South Korea-based biopharma company.
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Idorsiaâs glycan-targeting C diff. vaccine maintains positive clinical trajectory
Higher-dose cohort builds on earlier study data, positioning the synthetic glycan vaccine for future development.
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Pfizer partners with Innovent for $10.5bn to advance ADC oncology medicines
Licensing agreement builds on Innovent Biologicsâ earlier $11 billion collaboration with Takeda to develop novel ADC and immuno-oncology candidates.
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Novel CAR T manufacturing process significantly cuts production time
Efficacy findings comparable to those of existing CAR T cell therapies for relapsed/refractory multiple myeloma (r/r MM).