More news – Page 12
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NewsPfizer boosts its obesity plans with $2bn GLP-1 YaoPharma deal
The move builds on its recent billion-dollar acquisition of the obesity-focused biopharma company Metsera.
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NewsGamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
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CSL opens $1bn Australian vaccine and antivenom manufacturing facility
The Melbourne site adds Australia to a select group of nations with advanced cell-based influenza vaccine capabilities.
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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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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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NewsDupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.