EDITORIAL SECTION
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STRATEGY
Smarter Pharma
Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solution
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CLINICAL TRIALS
Why Clinical Trials Need Digital Endpoints
According Citeline the average success rate for bringing a Phase candidate to market has dropped to an alltime low of just
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MANUFACTURING
Ensuring Quality and Compliance in Biopharma
Ensuring quality and regulatory compliance in the biopharmaceutical industry is critical to safeguarding product safety and efficacy
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Information Technology
The Cost of Bad Data
Modern pharmaceutical research generates an unprecedented volume of information Data from genomic sequencing
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Biopharma
Reimagining Global Biomanufacturing Capacity with Continuous and Modular Systems
Biotechnology is fueling the ongoing expansion of the global market for a broad array of goods
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EXPERT Talk
Compliance to Competitive Advantage in Pharma Supply
Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser
Advisory Board
KNOWLEDGE BANK
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Articles
Bispecific Antibodies: Transforming the Future of Oncology
For two decades bispecific antibodies occupied an awkward position in pharmaceutical oncology strategy scientifically compelling commercially unproven and persistently difficult to manufacture That characterisation no longer holds Nineteen bispecific antibodies have been approved globally and combined sales of the class passed twelve billion dollars in with several products now anchoring
Manufacturing mRNA, Cell, and Gene Therapies at Commercial Scale
Why Cell and Gene Therapies Fail in Europe After the Science Has Already Worked The uncomfortable statistic for anyone financing advanced therapies in Europe is not the clinical attrition rate It is the withdrawal rate after approval An analysis of advanced therapy medicinal products granted European marketing authorisation found that roughly one in five had subsequently been withdrawn and of th...
Personalized Medicine and Longevity: Advancing the Frontier
The world is experiencing a profound demographic shift with population aging impacting healthcare economies and human rights The United Nations projects that by the number of people aged and over will double to billion comprising one in six people worldwide United Nations OHCHR By older adults will likely outnumber children necessitating a rethink of health aging and longevity Hartmann Young
Market Access Strategies for Pharma Products in Europe: A Comprehensive Guide
The European pharmaceutical market is dynamic and diverse presenting both opportunities and challenges for companies seeking market access This guide delves into effective strategies for navigating the complexities of market access in Europe focusing on key aspects such as reimbursement pricing and overcoming market entry challenges
Fostering Pharma Collaboration: Challenges & Opportunities
In the everevolving world of pharmaceuticals fostering collaboration is essential for driving innovation and meeting the diverse needs of patients However this seemingly simple goal is often hindered by numerous challenges
Cell and Gene Therapy's Trillion-Dollar Reckoning Is Here
Cell and gene therapies can cure diseases once thought untreatable Yet a string of commercial collapses now suggests that curing the patient and sustaining the business are two very different challenges and the industry is confronting the gap at last
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Techno Trends
University of Dundee’s Cabamiquine Shows Promise for Single-Dose Malaria Treatment
Researchers at the University of Dundee have reported encouraging clinical results for cabamiquine a novel antimalarial compound being developed as a potential singledose treatment for malaria
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Projects
Genentech to Invest US$750 Million in Oregon Device Fill-Finish Facility
Genentech a member of the Roche Group plans to invest approximately US million in a new device fillfinish manufacturing facility at its acre campus in Hillsboro Oregon The project will add endtoend manufacturing
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Research Insights
One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases
Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies
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whitepaper
Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact
For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys
TOP ARTICLES
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1
Manufacturing mRNA, Cell, and Gene Therapies at Commercial Scale
Lakshmi
Commercial scale means something different for mRNA, autologous cell therapy and in vivo gene therapy, and Europe adds a fourth dimension the science cannot solve: scaling across twenty-seven jurisdic...
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2
Personalized Medicine and Longevity: Advancing the Frontier
Dr. KaT Zarychta
Personalized medicine and longevity research are converging to advance healthcare frontiers. Innovations like genomic profiling, AI-driven diagnostics, and targeted interventions enable precision appr...
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3
Market Access Strategies for Pharma Products in Europe: A Comprehensive Guide
Kate Williamson
This comprehensive guide provides pharmaceutical companies with strategic insights for navigating the diverse European market. Focusing on reimbursement, pricing, and market entry challenges, it empha...
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4
Fostering Pharma Collaboration: Challenges & Opportunities
Kate Williamson
Fostering collaboration in the pharmaceutical industry is vital for innovation, yet challenges like regulatory hurdles, intellectual property concerns, and organizational barriers persist. Overcoming...
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5
Cell and Gene Therapy's Trillion-Dollar Reckoning Is Here
Lakshmi
Cell and gene therapies are transforming medicine, but commercial sustainability remains their greatest challenge. Despite scientific breakthroughs and a rapidly expanding pipeline, many developers fa...
press releases Read more...
Ionis partner Novartis announces Lp(a)HORIZON Phase 3 topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD)
Ionis Pharmaceuticals Inc Nasdaq IONS partner Novartis today announced that the pelacarsen Phase LpaHORIZON study a pioneering cardiovascular outcomes trial did not meet its primary endpoint
Novartis announces Lp(a)HORIZON Phase III topline results for pelacarsen in patients with elevated Lp(a) and established cardiovascular disease (CVD)
Novartis today announced that the pelacarsen phase III LpaHORIZON trial a pioneering cardiovascular outcomes study did not meet its primary endpoint of reducing the risk of cardiovascular events a composite
Climb Bio Announces CLYM116 Phase 1 Data Demonstrating Prolonged Half-Life and Best-In-Class APRIL Suppression Supporting Every-12-Week Dosing in IgA Nephropathy
Climb Bio Inc Nasdaq CLYM a clinicalstage biotechnology company developing therapeutics for patients with immunemediated diseases today announced positive initial data from the ongoing
Applied Biologics Achieves Key Preclinical Milestone in Disease-Modifying Osteoarthritis Gene Therapy Program
Applied Biologics a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs today announced an important preclinical milestone in its DiseaseModifying
Events Read more...
14 - 16
Sep 202614 - 15
Sep 202616th American DDF Summit
Omni Boston Hotel at the Seapo...
15 - 17
Sep 2026COPD Drug Development Summit 2026
Street, Boston, MA 02210, USA
21 - 23
Sep 2026Cell & Gene Therapy World Conference
Miami, Florida, USA
21 - 23
Sep 2026Cancer R&D World Conference
Hilton Garden Inn Miami Dolphi...
22 - 23
Sep 2026PDA Advanced Parenteral Therapeutics & Quality
Illume Hotel Taipei, Taiwan
22 - 24
Sep 2026InsurInnovator Connect Asia
Singapore
28 - 01
Sep 2026Discovery on Target 2026
Boston, MA, USA
LATEST NEWS Read more...
AtomVie opens new radiopharmaceutical manufacturing facility in Ontario
AtomVie Global Radiopharma AtomVie has opened a new purposebuilt radiopharmaceutical manufacturing facility in Hamilton Ontario strengthening its capacity to support drug development and commercial production
Acepodia receives FDA clearance for ACE723 antibody-drug conjugate
Acepodia a clinicalstage biotechnology company developing cell therapies and antibodydrug conjugates ADCs has received clearance from the US Food and Drug Administration FDA for its Investigational New Drug IND application for ACE
Kali Therapeutics Receives U.S. FDA Clearance for KT501 Clinical Trial
Kali Therapeutics a clinicalstage biotechnology company developing immuneresetting and multispecific therapies has received clearance from the US Food and Drug Administration FDA for its Investigational New
Abcam and Genedata Collaborate to Accelerate AI-Driven Antibody Development
Genedata has expanded its collaboration with Abcam to strengthen antibody development and support the use of artificial intelligence AI across Abcams global research and development operations
Evotec and Plectonic Enter Research Collaboration to Explore New T-Cell-Engaging Approaches for Solid Tumours
Evotec SE and Plectonic Biotech have entered a research collaboration to explore a new immunotherapy approach for solid tumours The partnership will combine Plectonics programmable LOGIBODY
NewBiologix and Synastra Biotechnology Partner to Advance Stable rAAV Manufacturing for Duchenne Muscular Dystrophy Gene Therapy
NewBiologix SA and Synastra Biotechnology Inc have entered into an agreement to develop a stable producer cell line for Synastras investigational gene therapy programme for Duchenne muscular dystrophy DMD








