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A four-step way out of pharma manufacturing’s asset management struggles
Here, Hexagon outlines a four-step plan to address silos and scale-up challenges, drawing on the experience of leading pharma firms like Pfizer.
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Biopharma
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Europe edges closer to formalising new ‘Pharma package’ industry rules
Progress made in the region’s approach to critical medicines and antibiotics as the EU Council and EU Parliament agree a new deal.
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Lilly to establish third new US manufacturing facility in Alabama
Announcement of Eli Lilly and Company's fourth new US manufacturing plant is expected within the next few weeks.
news
Gamida 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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A careful calibration: balancing small molecule needs and biologic innovation
CDMOs weigh up how to meet manufacturing demands across oral solid doses, monoclonal antibodies, ADCs and beyond.
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European 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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Takeda 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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Bristol 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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FDA 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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Could a simple handle change your cleanroom contamination risk?
MBV AG addresses challenges in air monitoring and aseptic handling with MAS-100 Sirius®: a next‑generation active microbial air sampler created in close collaboration with pharmaceutical manufacturers and cleanroom experts.
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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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UK 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.
webinar
Realising autonomous pharmaceutical operations
2 December 2025 | By Emerson
Join this webinar to discover how the pharmaceutical industry can move towards sustainable autonomous operations by implementing solutions that enhance pipeline acceleration, flexible manufacturing, operational integrity and real-time release.
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European Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
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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.
