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Pfizer 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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NewsJohnson & Johnson’s Caplyta demonstrates phase III promise for depression
Combination therapy comprising of an antidepressant and small molecule drug significantly boosted remission rates in adults with major depressive disorder.
NewsChemical assessment in Europe to be streamlined under new legislation
The European Commission’s new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
NewsEndotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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Novel 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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Day 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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Eli 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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Pharming 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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Optimised 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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MHRA 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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Day 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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FUJIFILM 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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FDA 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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Novel 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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Shionogi 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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Krystal 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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EU Commission agree to move Critical Medicines Act towards approval
Milestone agreement furthers proposals that help prevent drug shortages in Europe.
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Makary resigns as commissioner of US FDA
The resignation adds to staffing pressure as the US medicines regulator navigates continuing challenges.
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Study explores nanoparticle approach to pharmaceutical wastewater pollution
Marine bacteria and cerium oxide nanoparticles could reduce pharmaceutical contaminants and toxicity in wastewater, report shows.
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AI to accelerate Novo Nordisk’s Parkinson’s cell therapy
Cellular Intelligence’s AI-native platform to compress traditional process development for the pluripotent stem cell-derived dopaminergic progenitor therapy.
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MHRA proposes modernisation of gene therapy products classification
UK medicines agency calls for a more technologically neutral approach to the current legal definitions of gene therapy medicinal products.
News
FDA refines strategy with one-day inspectional assessment pilot
Initiative shown to enhance agency’s efficacy by increasing the number of facilities it can assess, without comprising regulatory rigour.
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New OCABR vaccine guidelines to improve regulation efficiency
One new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases.
News
Amgen invests additional $300m to strengthen biomanufacturing in Puerto Rico
Expansion brings firm’s total US manufacturing commitment over the last year to nearly $2 billion.