All articles by CE – Page 16
-
NewsIn-line pharma monitoring system developed for tablet quality inspection
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
-
News
Obesity drug competition fuels Novo Nordisk restructure
The company’s CEO says the shift will help prioritise investment into obesity and diabetes, the company’s leading therapy areas.
-
NewsFDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
-
News
Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
-
NewsWHO adds cancer and diabetes drugs to its essential medicines list
As an important policy tool, the new editions by the WHO mark a “significant” step in broadening access to new medicines with proven clinical benefits.
-
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.
-
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).
-
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.
-
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.
-
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.
-
NewsPharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
-
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.
-
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.
-
NewsEli 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.
-
NewsUnderstanding 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.
-
NewsPharma cautious about rushing towards direct-to-consumer drug sales
Disruption to traditional distribution channels is anticipated to hinder widespread adoption of the channel.