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UCB wins CHMP favour for first thymidine kinase 2 deficiency treatment
If approved by the European Commission, Kygevvi would provide a new treatment option for eligible patients with the ultra-rare mitochondrial disease in Europe.
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FDA launches PreCheck pilot programme for US pharma manufacturers
The regulator’s new programme aims to create more efficient regulatory review processes for new pharmaceutical manufacturing facilities.
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From quantum to clinic: AI reshapes clinical trials
The burden of conducting clinical trials is a significant hurdle in drug discovery. Here, Dr Mark Lambrecht reveals the technological developments that are driving shifts in this space.
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Dr David Berman to join Moderna as Chief Development Officer
Meanwhile, Dr Jacqueline Miller is stepping down as the company's Chief Medical Officer.
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Lilly chooses Pennsylvania for $3.5bn injectables manufacturing facility
Investment in the Lehigh Valley site finalises the last of the pharma company’s four new US manufacturing plants, supporting its onshoring of domestic medicine production.
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AstraZeneca makes $15bn manufacturing investment in China
Landmark, decade-long investment plan aims to support the pharma company’s 2030 revenue objective of $80 billion.
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Moderna and Recordati collaborate on rare disease mRNA therapy
License agreement set to advance mRNA-3927, a potential disease modifying therapy for the rare metabolic disorder propionic acidemia.
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Roche GLP-1 produces “robust” weight loss in late-stage obesity trial
The pharma company’s injectable GLP-1/GIP receptor agonist CT-388 is an important element of its weight loss strategy and also delivered benefits for pre-diabetic patients.
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FMT shows promise for enhancing immunotherapy effectiveness in advanced cancer
Phase II data derived from the first randomised trial comparing immunotherapy outcomes post-FMT from immunotherapy responders versus placebo.
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The future of pharma R&D leadership
People, not platforms, will define the next era of innovation, explain Chiesi’s Executive VP of R&D Diego Ardigò and Nick Petschek, EMEA Managing Director at Kotter.
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Innovative nanoparticle research could restore antibiotic efficacy
Disrupting drug-resistant Gram-negative pathogens is a potential breakthrough in addressing AMR and enhancing antibiotic success.
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Ipsen selects Pierrick Lefranc as new EVP Technical Operations
He brings 30 years of pharma industry experience to the role, principally in key manufacturing projects.
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UK ‘gaining pace’ with early-stage trials for advanced therapies
CGT Catapult research shows an increase in phase I/II trials, led by oncology but with clear growth in other disease areas such as inflammation.
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WuXi Biologics partners with HanchorBio on next-gen immunotherapies
The CRDMO will support the biotech company’s work on next-generation immunotherapies for oncology and autoimmune diseases.
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Advanced manufacturing research supports automated production of critical API
Study highlights potential of novel system for continuous, automated production of albuterol sulfate, an API on the US FDA’s drug shortage list.
