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Lilly picks Virginia for the first of its four new US manufacturing facilities
The new $5 billion manufacturing site is set to become the company’s first integrated facility for API and drug product manufacturing.
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Novartis builds on Monte Rosa collaboration with $5.7 billion deal
Expanding its collaboration with the US biotech will add novel molecular glue degrader-based medicines to the pharma company’s pipeline.
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ICH to implement M14 Guideline for post-marketing safety submissions
The ICH Assembly’s decision supports progress in promoting international standards for safety assessment of medicines.
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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.
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FDA 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.
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Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
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WHO 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.
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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.
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Roche 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).
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Demand 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.
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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.
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FDA 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.
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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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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.
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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.
