Sanofi’s Tzield type 1 diabetes immunotherapy wins UK first
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
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ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
Daewoong’s microneedle patch marks semaglutide first in obesity
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
Trump executive order targets US pharma supply chain resilience
Calls for active pharmaceutical ingredient (API) stockpile to cover around 26 ‘critical drugs’.
AbbVie invests $195m to expand API manufacturing in the US
The pharma company will add to its existing Chicago site, boosting its active pharmaceutical ingredient production capacity.
PureTech taps ex-Teva CEO to run its new respiratory unit Celea
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.
Bionova Scientific opens pDNA facility in the US
The CDMO’s new site will support its work in cell and gene therapy.
![Novartis logo Novartis building in Stein, Switzerland [Credit: Taljat David shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/novartis-image-300x278.jpg)
![Novartis logo Novartis building in Stein, Switzerland [Credit: Taljat David shutterstock.com]](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/novartis-image-scaled-e1594985022657.jpg)
Novartis scores Phase III wins for two ianalumab indications
Late-stage trials in Sjögren’s disease and primary immune thrombocytopenia met primary endpoints.
T-cell engagers set to drive immuno-oncology market
Amid intensifying market competition, the next-generation therapies could shape the future of oncology.
Vinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
Lilly to sell off Branchburg site as its global manufacturing plans take shape
The pharma company’s digital innovation efforts also progress with the opening of a new Hyderabad facility.
FDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
Steady progress for UK healthcare M&A in H1, report finds
Amid shifting global dynamics, continued resilience in UK healthcare M&A deal activity is expected in H2 2025, forecasting predicts.
EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
