All articles by Catherine Eckford (European Pharmaceutical Review) – Page 10
-
NewsBayer claims cell and gene therapy first in Parkinson’s research
Advances cell therapy and gene therapy candidates, with both showing neurorestorative potential against the disease.
-
NewsNovo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
-
NewsBiogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
-
NewsCPHI Pharma Awards 2025 finalists announced
Winners of this year's awards will be revealed during the opening of CPHI Frankfurt 2025.
-
NewsRoche pays $3.5bn for 89bio and its potential best-in-disease treatment MASH drug
The deal with the US biopharma could help address metabolic dysfunction-associated steatohepatitis, one of the most prevalent comorbidities of obesity.
-
NewsLilly 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.
-
NewsNovartis 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.
-
NewsICH 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.
-
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.