Tailored Artificial Intelligence (AI)
Controlling Polysorbate Degradation
Accelerating Cross-Sector Integration in Pharma and Nutraceuticals
Relatively Speaking
Early-Phase Oncology Trials Shaping the Future of Cancer Research
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
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KNOWLEDGE BANK
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Articles
Decision Integrity: The Layer ALCOA+ Was Never Built to Cover
When a model helps make a GxP call the data underneath it can be spotless and the decision still indefensible Here is where the gap opens and the controls that close it For years the discipline that has kept regulated records trustworthy is data integrity We learned ALCOA then ALCOA and built whole quality systems around the idea that a record has to be attributable legible contemporaneous origin...
The Cost of Uncertainty: How Analytical Chemistry Drives Billion-Dollar Decisions in Pharma
In pharmaceutical development uncertainty is not an abstract scientific inconvenience It has a cost a timeline a regulatory consequence and ultimately a patient impact A promising medicine may have strong biological rationale compelling early data and significant commercial potential yet still face a fundamental question do we truly understand the product well enough to develop manufacture approve...
Pharma Safety in Sterile Fill-Finish: Ensuring Quality and Compliance
The sterile fillfinish process is the final step in pharmaceutical manufacturing before medications reach patients This process is particularly critical for injectable drugs because they bypass the bodys natural defense mechanisms
The Role of Biosimilars in the European Pharma Market: Advancements, Challenges, and Future Perspectives
The European pharmaceutical landscape has undergone remarkable transformations in recent years with the emergence of biosimilars playing a pivotal role in reshaping the industry Before delving into the intricacies of biosimilars
The Role of Technology in Drug Anti-Counterfeiting Efforts
With the rise of drug counterfeiting posing a serious threat to global public health the role of technology in anticounterfeiting efforts has become increasingly vital As counterfeit drugs continue to infiltrate the market
Breaking Down Barriers: Advancements in Biodegradable Drug Delivery
In todays world where sustainability is a top priority breaking down barriers to a greener future is crucial One area where advancements are being made is in the field of biodegradable drug delivery
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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 Cost of Uncertainty: How Analytical Chemistry Drives Billion-Dollar Decisions in Pharma
Nithya Karakala
Analytical chemistry reduces uncertainty across pharmaceutical development by generating reliable data that supports critical decisions in quality, safety, manufacturing, and regulatory compliance. Ad...
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2
Pharma Safety in Sterile Fill-Finish: Ensuring Quality and Compliance
Kate Williamson
This comprehensive overview explores the critical aspects of ensuring safety and compliance in sterile fill-finish operations within the pharmaceutical industry. It discusses regulatory requirements,...
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3
The Role of Biosimilars in the European Pharma Market: Advancements, Challenges, and Future Perspectives
Kate Williamson
This article explores the evolving role of biosimilars in the European pharmaceutical market, focusing on advancements, challenges, and future perspectives. Biosimilars, mimicking existing biologics,...
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4
The Role of Technology in Drug Anti-Counterfeiting Efforts
Kate Williamson
The escalating threat of drug counterfeiting demands robust solutions. This article explores the pivotal role of technology, including blockchain, AI, and IoT, in anti-counterfeiting efforts. Serializ...
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5
Breaking Down Barriers: Advancements in Biodegradable Drug Delivery
Kate Williamson
This article discusses the benefits and advancements in biodegradable drug delivery systems, highlighting their role in improving patient outcomes and reducing environmental impact. It covers the adva...
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...
