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
Building Resilient Pharma Supply Chains to Strengthen Patient Care
The failure to deliver a temperaturesensitive biologic or a critical maintenance drug on time is becoming a patient outcome crisis not just an operational inefficiency By fortifying our global logistics networks we proactively safeguard the availability of lifesaving therapies and essential healthcare supplies securing the healthcare industrys central promise to global health This strategic impera...
Why is Pharmacogenetics and Pharmacogenomics Important?
In a world of increasingly personalized medicine the fields of pharmacogenetics and pharmacogenomics are gaining importance These disciplines explore the relationship between an individuals genetic makeup
Drug Safety in Focus: Challenges and Solutions for Pharma Companies
Drug safety is a paramount concern for pharmaceutical companies worldwide Ensuring the safety and efficacy of medications is not only a legal requirement but also a moral obligation towards patient welfare
Rethinking Make-or-Buy: Strategic Manufacturing Decisions in Pharma
Few strategic decisions in pharmaceutical operations carry as much longterm consequence as the choice of what to make and what to buy and few are revisited as rarely Network footprints agreed a decade ago partners selected during a capacity crunch technology transfers completed under launch pressure these choices harden into architecture They stop looking like decisions and start looking like the...
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
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...
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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
Why is Pharmacogenetics and Pharmacogenomics Important?
Kate Williamson
Pharmacogenetics and pharmacogenomics, exploring genetic influences on drug response, are pivotal in personalized medicine. By tailoring treatments to individual genetic makeup, these fields enhance d...
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2
Drug Safety in Focus: Challenges and Solutions for Pharma Companies
Kate Williamson
Drug safety is crucial for pharmaceutical companies, involving challenges like adverse event monitoring, data management, regulatory compliance, and patient reporting. Solutions include advanced pharm...
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3
Rethinking Make-or-Buy: Strategic Manufacturing Decisions in Pharma
Lakshmi
For three decades, pharmaceutical manufacturers treated outsourcing as the default answer to capacity, cost and speed pressures. Supply disruptions, modality complexity and regulatory scrutiny have si...
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4
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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5
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...
press releases Read more...
Fortrea and Omico Collaboration to Advance Biomarker-led Oncology Drug Development
Fortrea a leading global contract research organization CRO and Omico Australias leading precision oncology screening and trial matching organization today announced a collaboration to accelerate precision oncology research by helping connect cancer patients to biomarkermatched clinical trials By co...
ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations
AstraZeneca today announced the US availability of ZEGFROVY sunvozertinib for the treatment of adults with locally advanced or metastatic nonsmall cell lung cancer NSCLC whose tumors have epidermal growth factor receptor EGFR exon insertion mutations as detected by an FDAapproved test
Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia
Cardiff Oncology Inc a clinicalstage biotechnology company leveraging PLK inhibition to develop novel cancer therapies today announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to onvansertib for the treatment of patients with chronic myelomonocytic leukemia
Geneos Therapeutics Initiates IMPACT31 Phase 2 Randomized Clinical Trial Evaluating Neoantigen-Targeted Personalized DNA Immunotherapy for Cancer
Geneos Therapeutics a clinical stage biotherapeutics company focused on the development of neoantigenbased personalized immunotherapy for cancer PIC today announced the initiation of its Phase randomized clinical trial NCT in patients with highrisk hepatocellular carcinoma HCC liver cancer
Events Read more...
26 - 28
Oct 2026ACHEMA Middle East 2026
RICEC, Riyadh, KSA, Saudi Arab...
26 - 28
Oct 2026World Orphan Drug Congress
RAI, Amsterdam, Netherlands
27 - 28
Oct 2026Pharma Manufacturing & Automation Convention 2026
Novotel Hyderabad Airport, Ind...
28 - 30
Oct 2026BIOPLUS-INTERPHEX KOREA 2026
COEX, Seoul
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,...
LATEST NEWS Read more...
Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent
The Menarini Group a leading international pharmaceutical and diagnostics company and Stemline Therapeutics Inc Stemline a whollyowned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients along with Georgiamune Inc a clinicalstage biotechnology...
LGM Pharma Acquires Sannova Analytical, Expanding cGMP Analytical and GLP Bioanalytical Services
LGM Pharma a leading provider of tailored API sourcing contract analytical testing and drug development services today announced it has acquired Sannova Analytical a contract research laboratory headquartered in Somerset NJ The acquisition expands LGM Pharmas analytical testing services business by...
AI Proteins Announces Research Collaboration and License Agreement With Astellas Pharma to Discover and Develop Novel Miniprotein-Based Therapeutics Valued at Over $400 Million
AI Proteins Inc a biotechnology company that utilizes computational de novo protein design to create therapeutic miniproteins today announced it has entered into a Research Collaboration and License Agreement with Astellas Innovation Management LLC an affiliate of Astellas Pharma Inc TSE to discove...
Okomera Announces Trade Agreement with Servier to Use Tumor Miniaturization Technology in Cancer Research
Okomera a TechBio company that personalizes cancer management with its technology combining minivatars tumor microfluidics and AI imaging today announced the signing of a commercial agreement with Servier an independent international pharmaceutical group
ScionxBio Announces Collaboration to Develop Long-Acting xRNA Therapeutics
ScionxBio a privately held preclinicalstage biotechnology company pioneering nextgeneration mRNA therapeutics distinguished by their extended durability profile today announced that it has entered into a worldwide strategic collaboration and licensing agreement with Sanofi
Takara Bio USA Partners with SPT Labtech to Deliver Automation-Ready NGS Library Preparation Technologies
Takara Bio USA Inc a wholly owned subsidiary of Takara Bio Inc and SPT Labtech today announced their partnership to deliver validated automated library preparation workflows that combine Takara Bio nextgeneration sequencing NGS library preparation chemistries with SPT Labtechs firefly liquid handlin...





