News – Page 2
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NewsEU Commission issues plan to replace animal testing in chemical safety assessments
Publication marks a significant step towards modernising chemical safety assessments in Europe.
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NewsBiologics growth expected to reshape pharmaceutical packaging demand
Evolving regulatory requirements and ensuring product sterility and stability are driving demand for packaging innovation, particularly for biologic medicines, research suggests.
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NewsLilly licenses Hanmi’s GLP-2 biologic sonefpeglutide for $1.2bn
Agreement to develop and commercialise long-acting GLP drug candidate by South Korea-based biopharma company.
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NewsIdorsia’s glycan-targeting C diff. vaccine maintains positive clinical trajectory
Higher-dose cohort builds on earlier study data, positioning the synthetic glycan vaccine for future development.
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NewsPfizer partners with Innovent for $10.5bn to advance ADC oncology medicines
Licensing agreement builds on Innovent Biologics’ earlier $11 billion collaboration with Takeda to develop novel ADC and immuno-oncology candidates.
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NewsNovel CAR T manufacturing process significantly cuts production time
Efficacy findings comparable to those of existing CAR T cell therapies for relapsed/refractory multiple myeloma (r/r MM).
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NewsDay two in focus: navigating regulatory strategy at The Future of Bio/Pharmaceutical Analysis 2026
Day two of The Future of Bio/Pharmaceutical Analysis Virtual Summit 2026 focuses exclusively on regulatory strategy, with three panel sessions examining how compliance and quality pressures are reshaping how biopharma companies operate. From nitrosamine management to GLP-1 product quality, and from US agency dynamics to European regulatory reform, the programme addresses the practical challenges facing QA/QC professionals responsible for maintaining product safety and compliance in an increasingly complex drug development and manufacturing landscape.
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NewsEli Lilly bolsters infectious disease portfolio with acquisitions totalling $3.8bn
Investments in Curevo, LimmaTech Biologics and Vaccine Company set to advance vaccines for shingles, AMR-driving pathogens and Epstein-Barr Virus.
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NewsPharming secures novel EU approval for Joenja in activated PI3K delta syndrome
European approval provides a targeted approach that addresses the underlying pathophysiology of activated PI3K delta syndrome (APDS).
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NewsMacrophage cell therapy signals advancement in regenerative medicine
Treatment has potential to reduce the need for liver transplants in those with cirrhosis, long-term data suggests.
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NewsOptimised semaglutide formulation could advance peptide-based oral delivery
Study provides insight on enhancing the formulation development of GLP-1-targeting therapies for obesity and diabetes.
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NewsMHRA opens consultation for landmark rare disease therapy draft guidance
Agency’s proposal for a new model for rare disease therapy development in the UK compresses pathways, potentially enabling faster patient access.
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NewsDay one in focus: rethinking QA/QC at The Future of Bio/Pharmaceutical Analysis 2026
The Future of Bio/Pharmaceutical Analysis Virtual Summit returns 23–25 June 2026 with an opening day dedicated entirely to quality assurance and control. Three expert-led panel sessions will address environmental monitoring modernisation, endotoxin testing transformation and contamination control optimisation—examining how QA/QC disciplines are adapting to advanced therapies, sustainability demands and evolving regulatory expectations including Annex 1 implementation.
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NewsFUJIFILM Cellular Dynamics opens new US iPSC facility
New manufacturing site in Wisconsin expands production capacity and capabilities for induced pluripotent stem cell development and manufacturing.
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NewsFDA approves first-in-class aldosterone synthase inhibitor for uncontrolled hypertension
The US FDA has approved Baxfendy (baxdrostat), the first aldosterone synthase inhibitor for hypertension, offering a novel mechanism for approximately 23 million US patients whose blood pressure remains uncontrolled despite multiple medications.
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NewsNovel bioprocessing technology demonstrates one-step continuous operation
Simultaneous concentration and buffer exchange of mAbs through asymmetric dialysis may advance end-to-end continuous bioprocessing, suggests AstraZeneca study.
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NewsShionogi ranks second in 2026 Antimicrobial Resistance Benchmark report
Company’s efforts towards wastewater API controls and environmental risk management linked to AMR recognised by Access to Medicine Foundation’s Antimicrobial Resistance Benchmark 2026.
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NewsKrystal Biotech wins MHRA approval for genetic medicine Vyjuvek
Authorisation expands treatment options for UK patients with the rare genetic skin condition dystrophic epidermolysis bullosa.
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NewsEU Commission agree to move Critical Medicines Act towards approval
Milestone agreement furthers proposals that help prevent drug shortages in Europe.
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NewsMakary resigns as commissioner of US FDA
The resignation adds to staffing pressure as the US medicines regulator navigates continuing challenges.