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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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NewsNovel vaccine framework illustrates promise for oral cancer vaccines
Genetically modified Bifidobacterium could enhance patient response to immune checkpoint inhibitors, new clinical data suggests.
NewsFDA presents route to improve operational efficiency of drug manufacturing
Proposal aims to modernise registration for distributed drug manufacturers, strengthening real-time transparency across the pharmaceutical supply chain.
NewsEvonik invests $100m to modernise Indiana API facility
The move strengthens Evonik’s capabilities to manufacture increasing complex APIs at its site in Lafayette, Indiana.
NewsVertex acquires Crinetics in $10bn endocrinology deal
Acquisition set to bolster Vertex’s rare disease portfolio with addition of two potentially best-in-class endocrine assets.
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Study illustrates alternative to cold chain storage for mRNA vaccines
Research advances dry mRNA vaccine microneedle patch design, potentially improving storage and distribution of these types of vaccines.
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AbbVie’s epcoritamab combination approved as first bispecific therapy for follicular lymphoma in EU
European Commission’s approval brings a chemotherapy-free option to patients and develops AbbVie’s oncology and antibody portfolio.
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EDQM opens consultation on new revised draft Ph. Eur. monographs
CEP holders are invited to submit feedback on draft monographs for fifteen substances.
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Ipsen strengthens rare disease pipeline with €700m acquisition of Memo Therapeutics
Deal involves potential first-in-class BK polyomavirus monoclonal antibody as potential breakthrough therapy in kidney transplantation.
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US approval of Orca’s Tregzi landmark advance for stem cell transplants
FDA’s authorisation based on data showing the precision-engineered cell therapy improved survival free of GVHD in adults with haematological malignancies.
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Lonza expands manufacturing capacity for HPAPI and ADC payload-linkers
Investment at Lonza’s facility in Visp, Switzerland designed to meet increasing demand in the ADC market.
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Simplified C-glycosides synthesis could transform diabetes drug manufacturing
The two-step synthesis process offers a streamlined approach that removes longstanding barriers to scalable C-glycoside manufacture for SGLT2 inhibitors.
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Predictive stability modelling could optimise moisture-sensitive formulations
Research provides a data-driven foundation for excipient selection in drug formulation development, particularly solid dosage forms.
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Genentech’s Xofluza approved as first single-dose generic for influenza in US
FDA’s approval of generic baloxavir marboxil tablets for influenza broads access to a novel-mechanism antiviral for individuals aged five years and over.
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Novartis and Antares target undruggable oncology in $1.8bn deal
Agreement underlines growing investment in next-generation discovery platforms as pharma companies seek differentiated mechanisms of action in an increasingly competitive oncology landscape.
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EDQM removes rabbit pyrogen test references in revised OCABR guidelines
Guideline revisions support the EU’s ongoing transition away from using animals for in vivo testing of parenteral medicines.
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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.