All news articles – Page 14
-
News
FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
-
NewsGilead breaks ground on AI-enabled US manufacturing hub
Says the Bay Area building’s digital infrastructure will make it one of biopharma’s leading artificial intelligence-powered centres.
-
NewsRoche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
-
News
Amgen to build $600m science and innovation centre in the US
The new Thousand Oaks, California facility will incorporate advanced automation and digital capabilities.
-
NewsMerck’s health business gains new Global Head of R&D
David Weinreich will also serve as its Chief Medical Officer and arrives at the German pharmaceutical group with experience from Amgen, Bayer and Regeneron.
-
NewsDemand for AI-integration propelling mass spectrometry growth
Significant investment in advanced technologies Is expected to support global adoption of mass spectrometry in the next five years.
-
News
Critical Medicines Act 'must prioritise' EU pharmaceutical manufacturing competitiveness
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
-
NewsFDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
-
News
Chinese ADC dominance expected to drive the first bispecific approval
The first bispecific antibody drug conjugate market entrants are predicted to be in China or Japan as East Asia becomes a key battleground for local and multinational players.
-
NewsRoche touts ‘best-in-disease’ potential for anti-hypertensive zilebesiran
While AstraZeneca’s first-in-class candidate baxdrostat marks phase III hypertension win at ESC 2025.
-
News
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.
-
News
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.
-
NewsMHRA 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.
-
NewsFDA tightens use of Pfizer, Moderna and Novavax COVID-19 vaccines
RFK Jr hits Comirnaty, Spikevax and Nuvaxovid with revised approvals for ‘high risk’ individuals.
-
NewsPharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
-
NewsEuropean 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.
-
News
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.
-
News
FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
-
NewsUK 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.
-
News
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.