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.
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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.
Pharma cautious about rushing towards direct-to-consumer drug sales
Disruption to traditional distribution channels is anticipated to hinder widespread adoption of the channel.
CSL to slash headcount by 15% and spinout its CSL Seqirus vaccines business
The Australian biotech's new operating model will also see medical and commercial functions at its CSL Behring and CSL Vifor units combined.
WuXi Biologics granted novel authorisation for commercial biologic manufacturing in Ireland
The EMA’s decision permits WuXi Biologics to progress with commercial manufacturing of a global client’s innovative biologic.
