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
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
The FDA May Be Coming Unannounced to Your Facility: Are You Ready?
On May the President of the United States signed an executive order with far reaching impact on several agencies including the FDA Among other directives beginning in August the US Food and Drug Administration FDA will initiate unannounced inspections at nonUS manufacturing facilities involved in producing drugs biologics medical devices and diagnostics intended for American consumers and patie...
AI-Native R&D: Transforming Drug Discovery Through Intelligent Automation
For four decades pharmaceutical research productivity has moved stubbornly in the wrong direction A new medicine still takes ten to fifteen years to reach patients at a capitalised cost approaching US billion
How AI Is Addressing Drug Development Challenges in Rare Diseases?
Healthcare struggles with persistent obstacles to treat and understand rare diseases which societies call orphan diseases While affecting a minority portion of individuals these rare diseases make therapy discovery difficult because of scarce research data and expensive evaluation costs alongside multifaceted disease pathways The rising use of artificial intelligence AI drives a transformative cha...
Harnessing the Intracellular Machinery to Degrade Cellular Proteins
A countless number of proteins including growth factors receptors and cytokines play a pivotal role during the onset and exacerbation of numerous human diseases including cancer autoimmune and inflammatory disorders Of these proteins extracellular and membraneassociated proteins represent around of human proteome
Pharma Email Marketing Europe: Personalized Campaigns for C-Suite Leads
The pharmaceutical industry is a very competitive industry and to reach the decisionmakers a focused and strategic marketing strategy is necessary Conventional marketing is not often precise enough to reach executives that drive buying alliances and strategic relationships Here the pharma email marketing has come to play as a potent instrument of relationship establishment with the key stakeholder...
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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
The FDA May Be Coming Unannounced to Your Facility: Are You Ready?
Simona Mills
Benjamin Frey
An executive order was signed May 5, 2025, impacting the drug and medical device supply chain. Among other directives, beginning August 2025, the FDA will expand its inspection authority to incl...
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2
AI-Native R&D: Transforming Drug Discovery Through Intelligent Automation
Lakshmi
Artificial intelligence has moved beyond pilot projects into the architecture of pharmaceutical research itself. This article examines the shift from AI-enabled to AI-native R&D, in which closed-l...
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3
How AI Is Addressing Drug Development Challenges in Rare Diseases?
Kate Williamson
Drug development for rare diseases that affect less than 0.1% of the population proves challenging because of restricted data availability and small patient numbers and high project expenses. Modern d...
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4
Harnessing the Intracellular Machinery to Degrade Cellular Proteins
Marco Pirisinu
Targeted protein degradation is an continuously growing technology specifically developed to degrade proteins within and outside the cells. Given the impact that these targets play in human pathology...
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5
Pharma Email Marketing Europe: Personalized Campaigns for C-Suite Leads
Kate Williamson
Pharma email marketing allows pharmaceutical firms to engage high-value decision makers in Europe with personalized and data-based campaigns. When using the mix of targeted outreach, account-based mar...
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...





