EDITORIAL SECTION
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STRATEGY
Strategic Positioning for M&A
The biotechnology sector is characterised by a constant influx of small highly specialised companies
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solutions help reduce contamination risk and lower manual handling
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CLINICAL TRIALS
Virtual Clinical Trials
Virtual digital and decentralized are all descriptions of the novel ways that using technology changes
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Bio Pharma
Biosimilars and Biobetters
Biosimilars are biologic medical products that are essentially identical to an original product manufactured
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MANUFACTURING
Transformative Convergence of AI in Pharmaceutical Manufacturing
The pharmaceutical manufacturing industry is on the cusp of a revolutionary transformation driven by
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Information Technology
Transformative Impact of Artificial Intelligence on Clinical Trials
Artificial Intelligence AI has rapidly evolved from a futuristic concept to a transformative tool across various industries
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EXPERT Talk
Advancing Biopharmaceutical Innovation Through Cell Encapsulation and Biomimetic Therapeutic Systems
My interest in biopharmaceutical engineering began during my senior year as an undergraduate For my capstone project I worked on the encapsulation of...
Advisory Board
.webp "Juris Hmelnickis")
.webp "Eiman Shafa")
KNOWLEDGE BANK
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Articles
Mass Spectrometers: Principles, Instrumentation, Applications, and Future Perspectives
Mass spectrometry MS is one of the most powerful analytical technologies available in modern science It enables the identification characterization and quantification of compounds based on their masstocharge ratio mz Since its development in the early twentieth century mass spectrometry has evolved from a basic analytical tool into a sophisticated technology capable of studying highly complex biol...
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Techno Trends
FDA Authorises Aletta for Autonomous Blood Collection
The US Food and Drug Administration FDA has authorised Aletta the first standalone robotic device designed to collect blood from a patients arm without handson operator intervention
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Projects
Cambrex Expands Milan R&D Operations With US$30 Million Investment
Cambrex has begun construction of a new research and development facility at its Profarmico Milano site in Italy supported by a US million investment The initiative is designed
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Research Insights
CAVE-Onc: Graph-constrained agentic validation for cross-domain contradictions in CDISC oncology submissions
The CDISC Rules Engine CORE provides industrystandard validation for Study Data Tabulation Model SDTM submissions yet its imperative domainscoped architecture cannot express crossdomain contradictions
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White Papers
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 complexity
TOP ARTICLES
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1
FDA Regulatory Updates and Their Impact on Drug Approval Processes
Kate Williamson
This article will elaborate on the transformations of the restructured regulatory changes on the FDA drug approval processes, clinical development, compliance strategies, and accelerated pathways. It...
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2
The Outsourcing Advantage: Why Pharma’s Next Competitive Edge Will Be Built Through Ecosystems
Deepak Khurana
As pharmaceutical innovation becomes increasingly complex, strategic outsourcing has emerged as a critical growth enabler. Beyond cost optimisation, it provides access to specialised capabilities, acc...
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3
Biosimilar Market Access: Why Execution Gaps Cost Companies Hundreds of Millions
Doug Drysdale
The biosimilar market has generated over USD 56.2 billion in savings since 2015, yet many biosimilar companies systematically underperform on market access. This article examines four critical failure...
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4
Regulatory Affairs Outsourcing: Benefits, Challenges, and Best Practices
Kate Williamson
A major transformation of regulatory compliance to pharma, biotech, and medical device firms is the outsourcing of regulatory activities to meet their needs through the availability of specialized kno...
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5
The Future of Quality Control: ML Applications in Pharmaceuticals
Kate Williamson
This article explores the transformative impact of machine learning (ML) applications on quality control in the pharmaceutical industry. It delves into areas such as enhanced data analysis, adaptive q...
press releasesRead more...
Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer
AstraZenecas Etcamah camizestrant in combination with a cyclindependent kinase CDK inhibitor abemaciclib palbociclib or ribociclib has been approved in the US for the treatment of adult patients
Cipla Announces Exclusive Partnership with Qilu Pharmaceutical for the Licensing and Supply of Biosimilar to Keytruda® (Pembrolizumab) in the US FacebookPinterest
Invagen Pharmaceuticals Inc a wholly owned subsidiary of Cipla Limited BSE NSE CIPLA today announced that it has entered into a strategic partnership with Qilu Pharmaceutical Co Ltd
Fresenius Kabi Launches Generic Sugammadex in Simplist® Ready‑to‑Administer Prefilled Syringe in the U.S.
Fresenius Kabi a global healthcare company part of the Fresenius Group specializing in lifesaving therapies and technologies today announced the US launch of the FDAapproved generic Sugammadex
Lōkahi Therapeutics™ Expands ai² Futures Lab™ Asset Origination Network Through Continued Collaboration with the University of Georgia
Lkahi Therapeutics a subsidiary of Glucotrack Inc Nasdaq GCTK today announced the continued participation of the University of Georgias Student Industry Fellows Program in the ai Futures Lab
Events Read more...
09 - 10
Sep 2026iPSC Drug Development Summit
Hyatt Regency Boston Harbour,...
14 - 16
Sep 202614 - 15
Sep 202616th American DDF Summit
Omni Boston Hotel at the Seapo...
15 - 17
Sep 2026COPD Drug Development Summit 2026
Street, Boston, MA 02210, USA
21 - 23
Sep 2026Cell & Gene Therapy World Conference
Miami, Florida, USA
21 - 23
Sep 2026Cancer R&D World Conference
Hilton Garden Inn Miami Dolphi...
22 - 23
Sep 2026PDA Advanced Parenteral Therapeutics & Quality
Illume Hotel Taipei, Taiwan
22 - 24
Sep 2026InsurInnovator Connect Asia
Singapore
LATEST NEWSRead more...
Lupin receives US FDA approval for Modafinil tablets
Lupin has received approval from the US Food and Drug Administration FDA for its Abbreviated New Drug Application ANDA for Modafinil Tablets USP mg and mg
AtomVie opens new radiopharmaceutical manufacturing facility in Ontario
AtomVie Global Radiopharma AtomVie a contract development and manufacturing organisation CDMO specialising in radiopharmaceuticals has opened a new manufacturing facility in Hamilton Ontario
FDA Approves First Drug to Treat Alexander Disease
The US Food and Drug Administration FDA has approved Zanvastro zilganersen injection for the treatment of Alexander disease in paediatric and adult patients It is the first FDAapproved treatment
AbbVie Completes Acquisition of Apogee Therapeutics
AbbVie has completed its acquisition of Apogee Therapeutics bringing the biotechnology company and its pipeline of antibodybased treatments into AbbVie
EpiVax Launches AI-Enhanced Models for Immunogenicity Prediction
EpiVax Inc has launched AIenhanced features for ISPRI its in silico platform for assessing the immunogenicity risk of biotherapeutics The update includes an improved JanusMatrix model
Thermo Fisher Scientific Launches Multiskan™ Ease Absorbance Microplate Reader
Thermo Fisher Scientific has launched the Thermo Scientific Multiskan Ease Absorbance Microplate Reader designed to simplify routine laboratory analysis involving proteins cells and microorganisms
