All articles by Catherine Eckford (European Pharmaceutical Review) – Page 7
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NewsEuropean Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
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NewsTakeda expands its ADC and immuno-oncology pipeline as Innovent deal closes
The $11bn collaboration with the Chinese biopharma company gives Takeda the rights to several next-generation candidates.
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NewsBristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
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NewsFDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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CDER director Richard Pazdur to retire from FDA
In the interim, Dr Tracy Beth Høeg will serve as acting director for FDA's Center for Drug Evaluation and Research.
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Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
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NewsUK first country to secure zero-tariff US pharmaceuticals deal
New trade deal to “ignite economic growth” and help boost the UK’s position as a superpower in life sciences.
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NewsAbbVie’s atogepant illustrates migraine therapy label expansion potential
If approved in Europe, atogepant would provide patients with a new acute treatment option for migraine attacks.
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NewsBSI launches a world-first environmental standard for the pharma industry
New BSI standard PAS 2090 could reshape how the pharmaceutical industry reports and minimises its environmental footprint.
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NewsNovel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
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Innovative antibiotic-free method could limit biofilm formation
The proposed mechanical antibacterial approach offers a new way to use metal-organic frameworks, a Nobel Prize-winning material.
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NewsLife sciences responds to 2025 UK Autumn Budget
The modern Industrial Strategy is informing the UK government’s decisions in the Budget.
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NewsNovartis adjusts manufacturing strategy in Switzerland to secure competitiveness
Swiss pharma company to trim production of oral medicines and packaging in Stein, while boosting productivity in Schweizerhalle.
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Chiesi gains pace on climate target with new carbon minimal inhaler data
Findings presented at the British Thoracic Society (BTS) Winter Meeting back biopharma’s Net Zero commitment.
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NewsAlzheimer’s Phase III miss signals GLP-1RA combination therapy potential
Novo Nordisk is evaluating oral GLP-1 drug Rybelsus as a potential treatment in early symptomatic Alzheimer’s.
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AstraZeneca furthers US manufacturing commitment with $2bn Maryland investment
The move is part of biopharma's $50 billion pledge to US medicines manufacturing and R&D.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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NewsMedicines manufacturing in the UK to receive £54m sustainability boost
R&D projects supported by the Centre for Process Innovation (CPI) aim to shape a sustainable, resilient and competitive future for pharma manufacturing.