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
Pharmaceutical Business Strategy: Transformation, Regulation, Outsourcing and Growth
The pharmaceutical industry is standing at an unusual crossroads Patent cliffs are steeper regulators are tougher patients expect more transparency and payers are pushing back harder on price In this environment a strong Pharma Business Strategy is no longer a slide deck exercise for the boardroom its the difference between a company that scales globally and one that quietly fades into irrelevanc...
What Are the Implications of the Changing Regulatory Landscape in Europe?
In an age characterized by technological progress changing geopolitical scenarios and an increasing focus on sustainability businesses in Europe are grappling with an intricate network of regulatory shifts
How Digitalization Improves Pharma Manufacturing and Compliance
The pharmaceutical industry has been at a crossroads where the digitalization process is transforming the way drugs are developed manufactured and monitored Pharmaceutical companies are capitalizing on the power of digitalization in pharmaceutical production to maximize production improve traceability and regulatory compliance due to the tough regulatory requirements and the demand for absolute pr...
Building Patient-Centric Clinical Trials: Technologies, Strategies, and Regulatory Considerations
Patientcentricity in clinical trials represents a crucial cultural and operational transformation in the development and evaluation of new treatments The patient experience has evolved from a secondary consideration to a central priority in trial design driven by
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
Cold Chain Logistics for Pharmaceuticals: A Complete Guide to Compliance, Technology, and Best Practices
In the pharmaceutical industry preserving the integrity of temperaturesensitive products is crucial Cold chain logistics for pharmaceuticals play a vital role in ensuring that vaccines biologics and other temperaturesensitive medicines reach patients safely and effectively This complete guide explores pharmaceutical cold chain management focusing on compliance innovative technology and industry be...
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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
What Are the Implications of the Changing Regulatory Landscape in Europe?
Kate Williamson
The changing regulatory landscape in Europe, spanning data protection, digital services, climate action, finance, healthcare, Brexit impact, consumer protection, AI ethics, taxation, and telecommunica...
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2
How Digitalization Improves Pharma Manufacturing and Compliance
Kate Williamson
Digitalization of pharmaceutical production transforms the production, quality, and compliance by automation, data integration, and smart technologies. Using Pharma 4.0 principles, the companies obtai...
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3
Building Patient-Centric Clinical Trials: Technologies, Strategies, and Regulatory Considerations
Dr. Kalpana Katiyar
Ms. Shreeya Arora
Patient-centric clinical studies aim to improve the participant experience, foster diversity, enhance retention, and increase data quality. Advancements in decentralized trial models, digital health t...
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4
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...
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5
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








