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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AI digital twin developed to boost pharma manufacturing efficiency
The University of Cambridge and A*STAR platform aims to enhance fault detection, system monitoring and predictive maintenance.
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.
FDA tightens use of Pfizer, Moderna and Novavax COVID-19 vaccines
RFK Jr hits Comirnaty, Spikevax and Nuvaxovid with revised approvals for ‘high risk’ individuals.
Pharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
European decentralised CAR T manufacturing consortium launched
EASYGEN is supported by EU funding andindustry partners that include Fresenius, Charles River, Cellix, Pro-Liance and TQ Therapeutics.
Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
UK yet to agree on VPAG scheme following accelerated review
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
Johnson & Johnson builds on US manufacturing pledge with $2bn Fujifilm investment
Contracts to use a facility at Fujifilm’s North Carolina site as part of moves to onshore its manufacturing.
Gilead’s Kite agrees $350m deal to acquire US biotech Interius BioTherapeutics
Will expand the company’s CAR T-cell therapy footprint and gain access next generation in vivo technology.
Eli Lilly neuroscience executive Anne White to retire
Her leadership experience spans three decades with Lilly, across multiple therapeutic areas including oncology, neuroscience and infectious disease.
Understanding European regulatory requirements for low-GWP propellant transition
The paper explores recent guidance by the EMA and aims to help companies ensure their developments are efficient and effective for the forthcoming transition.
Boehringer Ingelheim signs gene therapy manufacturing deal with AnGes
The German pharma company’s BioXcellence arm will supply the drug substance for AnGes’ peripheral arterial disease treatment Collategene.
Merck’s SpringWorks Therapeutics gains European approval for Ogsiveo
The drug is the first treatment for desmoid tumours to be approved in the region.
