All articles by Catherine Eckford
-
NewsEli Lilly bolsters infectious disease portfolio with acquisitions totalling $3.8bn
Investments in Curevo, LimmaTech Biologics and Vaccine Company set to advance vaccines for shingles, AMR-driving pathogens and Epstein-Barr Virus.
-
NewsPharming secures novel EU approval for Joenja in activated PI3K delta syndrome
European approval provides a targeted approach that addresses the underlying pathophysiology of activated PI3K delta syndrome (APDS).
-
ArticleMacrophage cell therapy signals advancement in regenerative medicine
Treatment has potential to reduce the need for liver transplants in those with cirrhosis, long-term data suggests.
-
NewsOptimised semaglutide formulation could advance peptide-based oral delivery
Study provides insight on enhancing the formulation development of GLP-1-targeting therapies for obesity and diabetes.
-
NewsMHRA opens consultation for landmark rare disease therapy draft guidance
Agency’s proposal for a new model for rare disease therapy development in the UK compresses pathways, potentially enabling faster patient access.
-
NewsFUJIFILM Cellular Dynamics opens new US iPSC facility
New manufacturing site in Wisconsin expands production capacity and capabilities for induced pluripotent stem cell development and manufacturing.
-
NewsNovel bioprocessing technology demonstrates one-step continuous operation
Simultaneous concentration and buffer exchange of mAbs through asymmetric dialysis may advance end-to-end continuous bioprocessing, suggests AstraZeneca study.
-
NewsKrystal Biotech wins MHRA approval for genetic medicine Vyjuvek
Authorisation expands treatment options for UK patients with the rare genetic skin condition dystrophic epidermolysis bullosa.
-
NewsEU Commission agree to move Critical Medicines Act towards approval
Milestone agreement furthers proposals that help prevent drug shortages in Europe.
-
NewsMakary resigns as commissioner of US FDA
The resignation adds to staffing pressure as the US medicines regulator navigates continuing challenges.
-
NewsAI to accelerate Novo Nordisk’s Parkinson’s cell therapy
Cellular Intelligence’s AI-native platform to compress traditional process development for the pluripotent stem cell-derived dopaminergic progenitor therapy.
-
NewsMHRA proposes modernisation of gene therapy products classification
UK medicines agency calls for a more technologically neutral approach to the current legal definitions of gene therapy medicinal products.
-
NewsFDA refines strategy with one-day inspectional assessment pilot
Initiative shown to enhance agency’s efficacy by increasing the number of facilities it can assess, without comprising regulatory rigour.
-
NewsNew OCABR vaccine guidelines to improve regulation efficiency
One new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases.
-
NewsAmgen invests additional $300m to strengthen biomanufacturing in Puerto Rico
Expansion brings firm’s total US manufacturing commitment over the last year to nearly $2 billion.
-
NewsNovartis to site seventh new facility in North Carolina
New active pharmaceutical ingredient (API) facility in Morrisville to enable end‑to‑end manufacturing in the US.
-
NewsFDA marks progress in implementing real-time clinical trials
Advances agency’s goal in facilitating continuous trials, aimed at accelerating promising therapies.
-
NewsBioplastic produced from hemp waste potential eco-alternative for packaging films
Plant-based biocomposites improved resource efficiency and added value from biomass waste, study shows.
-
NewsBoehringer’s GLP-1 dual agonist survodutide shines in phase III trial
Survodutide could become first global glucagon/GLP-1 dual agonist, new phase III findings suggest.
-
NewsLilly adds potential first-in-class Type II JAK2 inhibitor to haematology portfolio
The pharmaceutical company’s $2.3 billion acquisition of Ajax Therapeutics set to advance outcomes for myeloproliferative neoplasms.