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
Digital Twins: The Future Blueprint for Pharmaceutical Production
Digital Twins have revolutionized the pharmaceutical industry by providing virtual replicas of physical assets and processes This innovative technology offers a comprehensive view of manufacturing
Fundamentals of Clinical Pharmacology: Understanding Drug Actions and Ensuring Safety
Clinical pharmacology offers the interface between the philosophies of pharmacology and its application in the actual sense in patient care Fundamentally it is the science which examines the activities of drugs how drugs communicate with biological systems and how such communications result in treatment outcomes or adverse events Clinical pharmacology principles are needed to make sense of how m...
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
As of August the EU AI Act is generally applicable although some obligations for highrisk AI systems apply at later dates For pharmacovigilance organisations a key consideration is to determine the role and classification of each AI system under the Act rather than assuming that AI used in PV is automatically classified as highrisk AIliteracy requirements are already applicable while provider and...
How Can Smart Packaging Revolutionize Pharma with Track-and-Trace Solutions?
Did you know that smart packaging has the potential to revolutionize the pharmaceutical industry With trackandtrace solutions this innovative technology can enhance transparency safety and efficiency in the pharma supply chain
The Competitive Generic Therapy (CGT)
Generic medications are critical in the healthcare sector due to their affordability and accessibility to the public while maintaining comparable quality efficacy and safety to that of branded products Generic medications research and development followed by commercialisation also fosters competition and innovation within the pharmaceutical
The Future of Pharma and CRO Operations: A Practical Guide to Automation
Many pharmaceutical leaders assume productivity gains will come from copilots conversational tools that help staff draft text or find information faster Yet copilots remain confined to the surface of work They assist with isolated tasks but cannot follow a process through to completion They do not manage clinical operations budgets or respond to RFPs for instance
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Techno Trends
Alume Biosciences Secures FDA Breakthrough Therapy Designation for Bevonescein
Alume Biosciences has received Breakthrough Therapy Designation BTD from the US Food and Drug Administration FDA for bevonescein an investigational fluorescent drug being developed to support realtime nerve visualisation during head and neck surgery in adults Bevonescein is an intravenous fluorescent peptidedye conjugate that binds to nerve tissue
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Projects
SK pharmteco Plans More Than US$200 Million Investment in Small Molecule and Peptide Manufacturing
SK pharmteco is planning a fiveyear investment of more than US million to expand and modernise its pharmaceutical development and manufacturing operations in the United States The programme will strengthen capabilities for small molecules and peptides while supporting a more
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Research Insights
A drug repurposing screen reveals dopamine signaling as a candidate therapeutic pathway for PIGA-CDG
PIGACDG is a congenital disorder of glycosylation caused by pathogenic partial lossoffunction variants in the PIGA gene PIGA encodes an enzyme responsible for the catalytic transfer of Nacetylglucosamine
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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
Fundamentals of Clinical Pharmacology: Understanding Drug Actions and Ensuring Safety
Kate Williamson
This article will discuss the fundamentals of clinical pharmacology, drug effects, pharmacodynamics and pharmacokinetics. It highlights evidence-based practice of drug safety, pharmacovigilance, and r...
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2
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
Andreas Hofmann
Artificial intelligence can increasingly extract, structure, and compare pharmacovigilance-relevant information from scientific literature. The key question is no longer whether AI can support literat...
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3
How Can Smart Packaging Revolutionize Pharma with Track-and-Trace Solutions?
Kate Williamson
Smart packaging with track-and-trace solutions is revolutionizing the pharmaceutical industry by enhancing supply chain transparency, preventing counterfeit drugs, and improving patient safety. Techno...
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4
The Competitive Generic Therapy (CGT)
Raghunandhan Painoori
Dr. Naveen Chella
The Competitive Generic Therapy (CGT) Act, introduced by the US FDA in 2017 under the Generic Drug User Fee Act (GDUFA), aims to lower drug costs by promoting generics where competition is limited. It...
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5
The Future of Pharma and CRO Operations: A Practical Guide to Automation
Dr. Darko Matovski
Pharmaceutical productivity is shifting from copilots to Digital Workers - AI systems that execute and oversee end-to-end operations. Unlike task assistants, they manage compliant and cross-functional...
press releases Read more...
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)
INOVIO a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPVrelated diseases cancer and infectious diseases today announced that the US Food and Drug Administration FDA has granted accelerated approval for VOCERYQ doruxapapogene ral...
Helsinn announces UK MHRA approval of AKYNZEO® Oral Suspension
Helsinn Healthcare SA a global pharmaceutical group focused on supporting patients with cancer and chronic diseases today announced that the UK Medicines and Healthcare products Regulatory Agency MHRA has granted approval for the oral suspension formulation of AKYNZEO netupitantpalonosetron for the...
Transcripta Bio Announces Research Collaboration to Advance Discovery of New Treatments for Autism Spectrum Disorder
Transcripta Bio an AIpowered drug discovery company focused on neurological and neuromuscular diseases today announced a knowhow agreement with Mayo Clinic focused on the molecular characterization of autism spectrum disorder ASD The collaboration seeks to combine Mayo Clinics clinical genomics and...
Carterra and Grenova Robotics Integrate Carterra Vega™ with KX2 Collaborative Robot to Create Automated HT-SPR Work Cell
Carterra and Grenova Robotics today announced the integration of Carterra Vega highthroughput surface plasmon resonance HTSPR platform with Grenova Robotics KX collaborative robot to create an automated work cell for drug discovery laboratories The integrated system enables researchers
Events Read more...
02 - 04
Nov 2026Pharma Forum EMEA 2026
Dom Pedro Lisboa Hotel, Lisbon...
02 - 04
Nov 2026Cancer R&D 2026
Houston, TX, USA
03 - 05
Nov 202610th Dermatology Drug Development
Boston, Massachusetts at The C...
03 - 04
Nov 2026PDA Aseptic Processing of Biopharma Conference
Sheraton Grand Incheon Hotel,...
04 - 05
Nov 2026Advanced Therapies USA
Hynes Convention Center, Bosto...
05 - 05
Nov 2026PDA Contamination Control Strategy Workshop
Sheraton Grand Incheon Hotel,...
09 - 11
Nov 202611th Microbiome Movement USA Summit
The Colonnade Hotel, Boston, M...
10 - 11
Nov 2026Extractables & Leachables Europe
Parkhotel Schӧnbrunn, Vienna,...
LATEST NEWS Read more...
Pretzel Therapeutics Receives UK Regulatory Authorization to Advance PX578 Into Clinical Development in Patients for the Treatment of POLG-Mediated Primary Mitochondrial Disorders
Pretzel Therapeutics Inc a clinicalstage biotechnology company advancing a new class of medicines designed to restore mitochondrial function improve cellular energetics and impede disease progression across a range of neurological and rare diseases today announced that the Medicines and Healthcare p...
TME Pharma Signs Binding Exclusive Negotiation Agreement with Japanese TMS Co., Ltd.
TME Pharma NV Euronext Growth Paris ALTME a biotechcompany with clinical assets for brain cancer and eye diseases is pleased to announce a significant next step in the strategic options for its leading oncology asset NOXA olaptesed pegol
Twist Bioscience Launches MRD Express with Rapid Turnaround Time
Twist Bioscience Corporation a midcap growth and value biotech company today launched Twist MRD Express custom panels manufactured at scale with a rapid turnaround time starting within one day Twist MRD Express custom panels enable cancer researchers to investigate tumorassociated genomic variants
Strand Therapeutics Doses First Patients with STX-003, a Systemic Programmable mRNA Therapy Designed for Tumor-Selective Activation
Strand Therapeutics a clinicalstage biotechnology company pioneering programmable mRNA therapeutics today announced that the first patients have been dosed in ASCENT the Phase clinical trial of STX STX is an intravenously delivered selfreplicating mRNA therapy designed
Idorsia and SPV investors partner to unlock the blockbuster potential of TRYVIO/JERAYGO with a targeted launch in specialists
Idorsia Ltd announced a proposed commercialization partnership between Idorsia and noteholders in Idorsia Investments SARL SPV designed to unlock the substantial global commercial opportunity of TRYVIO JERAYGO aprocitentan the first and only dual endothelin receptor antagonist approved for systemic
Roche strengthens cancer diagnostic portfolio with launch of test for differential diagnosis of mesothelioma
Roche announced today the global launch of the VENTANA BAP SP test This automated readytouse immunohistochemistry IHC assay provides a reliable highly specific diagnostic tool to help clinicians and pathologists accurately identify mesothelioma and distinguish it from other malignancies including no...





