All Drug Development articles
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ArticlePrecision control for target protein degraders
Target protein degraders offer therapeutic potential, yet their high potency, poor solubility and ultra-low administered doses place significant demands on formulation science, analytical capability, containment and scalable manufacture. Successful development requires solubility enhancement, particle engineering, excipient design, high-potency containment and process development to be considered together from the earliest programme stages.
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ArticleThe next frontier in nitrosamine testing: detection and risk assessment in packaging and IV infusion bags
Join Waters Corporation on the 23rd September for their webinar on the latest developments in nitrosamines testing, evolving regulatory expectations, analytical challenges, and advanced LC-MS/MS strategies for sensitive detection and risk assessment.
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ArticleClosing the data integrity gap in pharmaceutical quality control
Pharmaceutical quality control laboratories face growing pressure to strengthen data integrity as regulators scrutinise incomplete records, manual data entry, and disconnected systems.
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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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NewsSandoz partners with Samsung Bioepis to accelerate biosimilar pipeline
New licensing, development and commercialisation agreement could expand Sandoz’s pipeline by to up to 32 assets.
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NewsUpcycled plastic could facilitate production of Parkinson’s drug
Bioengineered E.coli provide an eco alternative to creating L-DOPA from terephthalic acid, suggests study.
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NewsSana's islet cell transplant therapy shows early promise in type 1 diabetes
Biotech company’s long-term data demonstrated hypoimmune (HIP)-modified islet transplantation without immunosuppression in type 1 diabetes.
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NewsGSK grants rare disease firm Alfasigma rights to linerixibat for $690m
Licence agreement with the Italy-based pharma company to advance GSK’s ambitions in rare disease.
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NewsFDA revises PK study approach in new biosimilar draft guidance
Sandoz is also adjusting its global strategy by recruiting Armin Metzger as President of Biosimilar Development, Manufacturing & Supply.
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NewsServier deepens rare oncology commitment with $2.5bn Day One acquisition
The deal aligns with the biopharma company’s goal of expanding its oncology pipeline by the end of the decade.
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NewsSanofi gains access to first-in-class JAK inhibitor through $1.5bn licensing deal
Oral small molecule therapy rovadicitnib from Sino Biopharmaceutical offers potential to advance the pharma company’s haematology portfolio.
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ReportPharma Horizons: Trends in Pharmaceutical Manufacturing
EPR’s 2026 pharma manufacturing trends report covers the key developments in supply chain, quality, drug development, new modalities and beyond.
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NewsUCB signs $1.1bn to autoimmune collaboration with Chinese biotech Antengene
License agreement involves development of ATG-201, a B cell-depleting bispecific T-cell engager, supporting the biopharma company’s immunology pipeline.
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NewsLipid nanoparticle discovery could increase drug delivery efficiency
Study findings offer potential to accelerate development of RNA-based medicines.
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NewsNovo Nordisk strikes $2.1bn oral obesity biologic deal with Vivtex
Drug delivery partnership to advance next-generation oral therapies and help Novo Nordisk expand its obesity and diabetes portfolio.
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NewsGSK acquires TGF-beta protein firm 35Pharma for nearly $1bn
Acquisition will help GSK scale its pipeline for respiratory, immunology and inflammatory diseases.
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NewsAbbVie invests $380m in Illinois to expand US API manufacturing
Decision forms part of the pharma company’s plan to commit $100 billion to its R&D capabilities in the US over the next decade.
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ArticleApplying AI to enhance drug formulation and development
AI/ML is not replacing formulation scientists or process engineers; it is just amplifying their expertise.
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NewsFDA drafts new ultra-rare disease therapy guidance
Agency’s planned framework is the first to support the approval process for new ultra-rare disease treatments.
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NewsGilead adds to cell therapy portfolio with $8bn acquisition of Arcellx
Deal builds on the companies’ 2022 collaboration over CAR T therapy anito-cel.