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
Clinical Trials: Failures and Challenges on the Path to Treating Alzheimer’s
Alzheimers disease AD is a neurodegenerative disorder with symptoms of memory loss and cognitive disability Typically it begins with mild symptoms that progress to become more severe AD is the th leading cause of death in the United States among people or older In million Americans suffered from AD and this is expected to rise to million by
From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy
Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing
Nanosizing: An Enthralling Strategy to Improve the Systemic Availability of Poorly Soluble Drugs
To enable the effective preclinical testing efficacy and safety evaluation followed by firstinman studies formulation scientists must come up with effective strategies to achieve the desired bioavailability of these poorly soluble compounds
Blockchain in Pharma: Strengthening Drug Traceability, Compliance, and Supply Chain Security
For most of the last decade the European pharmaceutical industry framed supply chain integrity as a packaging problem Put a unique identifier on every pack seal it with an antitampering device check it at the point of dispensing and the falsified medicine threat would be contained Since February that model has been law across the European Union and it has worked better than many sceptics predicte...
Adaptive Trial Designs: Enhancing Speed and Decision-Making in Clinical Development
For decades the traditional clinical trial has followed a rigid script A protocol is written patients are enrolled the study runs to completion and only at the very end does the sponsor learn whether the investment paid off The model has served the industry well in terms of scientific rigour
Greening the Pill: Pharmaceutical Companies Embrace Environmental Sustainability
In an age where global environmental sustainability is imperative various industries are reassessing their practices to diminish their ecological impact The pharmaceutical sector a crucial component of healthcare is no different This article explores the proactive steps taken by pharmaceutical companies to incorporate sustainability into manufacturing packaging and operations to lessen their envir...
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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
From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy
Lakshmi
Regulatory readiness is still treated by many pharmaceutical organisations as a late compliance exercise, bolted on once a molecule has been designed, scaled and transferred. That sequencing has becom...
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2
Nanosizing: An Enthralling Strategy to Improve the Systemic Availability of Poorly Soluble Drugs
Dr. Yogeshwar Bachhav
Dr. Chandrakantsing Pardeshi
Dr. Raju Sonawane
The majority of the NCEs in the pipeline, especially in the case of oncology and anti-infective indications, are poorly soluble and have posed a major threat to the overall drug development process.
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3
Blockchain in Pharma: Strengthening Drug Traceability, Compliance, and Supply Chain Security
Lakshmi
Europe’s pharmaceutical supply chain has never been more regulated, more fragmented or more exposed. The Falsified Medicines Directive delivered pack-level verification, but it largely stops at...
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4
Adaptive Trial Designs: Enhancing Speed and Decision-Making in Clinical Development
Lakshmi
Clinical development remains the most expensive and uncertain stage of bringing a medicine to market, with fixed, linear trial designs often committing billions to hypotheses that could have been test...
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5
Greening the Pill: Pharmaceutical Companies Embrace Environmental Sustainability
Debi Jones
Pharmaceutical companies are actively embracing environmental sustainability, implementing green chemistry in manufacturing, adopting renewable energy sources, and reducing single-use plastics through...
press releases Read more...
Syndax’s Revuforj® (revumenib) Wins Prestigious 2026 Prix Galien USA Award for Best Product for Rare/Orphan Diseases
Syndax Pharmaceuticals a commercialstage biopharmaceutical company advancing innovative cancer therapies today announced that Revuforj revumenib has been recognized as the Best Product for RareOrphan Diseases of by The Galien Foundation The Galien Foundation fosters
Massive Bio and Global Leadership in Oncology & Wellness (GLOW) Announce Partnership to Expand Access to Clinical Trial Information for Patients and Caregivers
Massive Bio an agentic AI and realworld data RWD company advancing oncology drug development commercialization and access to precision medicine today announced a partnership with Global Leadership in Oncology Wellness GLOW a c nonprofit dedicated to bridging the gap between patients
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...
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...
UroGen Announces First Patient Dosed in Phase 1 Trial of UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers today announced that the first patient was dosed with UGN a nextgeneration investigational oncolytic virus The Phase trial will evaluate the safety tolera...
Graviton BioScience and CinRx Pharma Form CinRock Pharma to Advance ROCK2-Targeted Therapies for Cardiovascular Disease
Graviton BioScience Corporation Graviton and CinRx Pharma CinRx today announced the formation of CinRock Pharma CinRock a jointly governed biopharmaceutical company established to accelerate the development of novel ROCKtargeted therapies for patients with cardiovascular diseases
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





