Artificial intelligence is shifting formulation development from empirical trial-and-error to predictive, data-driven design ...

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Procurement frameworks now incorporate resilience criteria, enabling tender preference for diversified, Europe-based manufacturing and contingency capacity over lowest price, reshaping economics for ...

Collectively, the deals reposition vaccines as long-horizon disease-modifying infrastructure, leveraging epidemiologic and mechanistic links between infections (eg, VZV, EBV) and neurodegeneration, ...

Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging ...

Tracy Beth Høeg said she was fired; Katherine Szarama departs as acting CBER director but remains at FDA, signaling rapid ...

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

Benralizumab gained approval for adult and pediatric hypereosinophilic syndrome with a 65% flare-risk reduction, underscoring lifecycle strategies that impose distinct dosing, formulation, and ...

Upstream titers of 3–5 g/L, and up to 10–13 g/L, are outpacing downstream capacity, creating chromatography, filtration, and UF/DF throughput bottlenecks that elevate cost and delay timelines. Complex ...

Annex 1 reframes sterility assurance from prescriptive checklists to a performance-based, prevention-first contamination control strategy spanning the full product life cycle. Sponsor gaps—limited ...

Makary highlighted hospital contract negotiations, duplicative ethics review, and IND process variability as primary sources of US early-phase cycle-time inflation. China’s ICH accession and ...

Majority ownership of ProSys enables tighter integration of specialized sampling and isolation equipment within a global machinery platform, potentially improving access to high-integrity aseptic and ...