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
R&D Strategies for First-in-Class and Best-in-Class Therapeutics
Ask a US pharmaceutical executive whether their company pursues firstinclass or bestinclass assets and the answer is almost always both Ask how the portfolio is governed resourced and measured and the answer is almost always as though there were only one kind of program The same stage gates the same probabilityofsuccess assumptions the same commercial forecasting templates
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Techno Trends
Galibra Gains FDA Designations for SSADH Gene Therapy
Galibra Neuroscience has received Orphan Drug Designation ODD and Rare Pediatric Disease Designation RPDD from the US Food and Drug Administration FDA for its investigational gene therapy for succinic semialdehyde dehydrogenase SSADH deficiency
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Projects
Octapharma Announces US$1.5 Billion Plasma Manufacturing Facility in South Carolina
Octapharma has announced plans to develop its first USbased manufacturing and production facility at Palmetto Research Park in Rock Hill South Carolina with an investment of US billion
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Research Insights
Drug Costs in Federally Sponsored Cancer Clinical Trials
Importance Federally sponsored cancer clinical trials FSCCTs address research questions often overlooked by industry eg pharmaceutical or biotechnology companies such as treatment combinations
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White Papers
Accelerating In-Vitro Antibody Discovery with Artificial Intelligence
Antibodies have transformed modern medicine reshaping treatment paradigms across autoimmune disorders oncology and infectious diseases As one of the most versatile and successful therapeutic modalities
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
From Pipelines to Platforms: How AI Investments Are Transforming Biotech and Pharma’s Operating Model
Kishore Raju Vatsavai
Artificial intelligence (AI) is becoming a strategic priority across the pharmaceutical industry. Companies are investing heavily in AI to improve research productivity, accelerate drug discovery, and...
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3
Inside the Approval Timeline: Where Programs Really Lose Months
Lakshmi
Most programs don't lose their timeline to a single dramatic failure—they lose it quietly, in the seams between functions. This article reframes the approval timeline as an operational syste...
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4
Efficiency and Quality in Pharma: Leveraging Lean Six Sigma Integration
Kate Williamson
This article explores the integration of Lean Six Sigma principles in the pharmaceutical industry to enhance efficiency and quality. It covers benefits such as improved process efficiency, enhanced pr...
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5
Stem Cell Technology: The Future of Drug Discovery and Regenerative Medicine
Kate Williamson
Drug discovery together with regenerative medicine undergoes revolutionary changes because stem cell technology allows appropriate drug testing and tissue reconstruction and customized therapeutic app...
press releasesRead more...
Monod Bio Licenses AI-designed Protein Technologies to SignalChem Biotech for Custom Discovery Assays
Monod Bio a Seattlebased AIenabled protein design company and SignalChem Biotech Inc a whollyowned subsidiary of Sino Biological Inc SZSE today announced a nonexclusive licensing agreement
BridgeBio Announces First Participant Dosed in ASCEND-ATTR, a Phase 3b/4 Study Evaluating the Long-Term Effects of Acoramidis on Disease Regression in ATTR-CM
BridgeBio Pharma Inc a commercialstage multiproduct biopharmaceutical company focused on developing medicines for genetic conditions announced today that the first participant has been dosed
Mahzi Therapeutics Announces FDA Rare Pediatric Disease Designation for MZ-1866 Investigational Therapy for Pitt Hopkins Syndrome
Mahzi Therapeutics Inc a clinicalstage biotechnology company developing precision therapies for neurogenetic disorders today announced that the US Food and Drug Administration FDA
Abbott receives FDA authorization for world's first dual glucose-ketone sensing technology for people with diabetes
Abbott NYSE ABT the global healthcare leader today announced US Food and Drug Administration FDA authorization of its Libre Duo Day system the worlds first dual glucoseketone sensing technology
Events Read more...
03 - 05
Sep 20265th MENA Congress for Rare Diseases 2026
Beach Rotana Hotel, Abu Dhabi,...
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
LATEST NEWSRead more...
FDA Approves Revolution Medicines’ RASONQUE for Metastatic Pancreatic Cancer
The US Food and Drug Administration FDA has approved Revolution Medicines RASONQUE daraxonrasib tablets for adults with metastatic pancreatic adenocarcinoma PDAC who have received at least one previous systemic treatment or are not candidates for multiagent systemic therapy
U.S. FDA Approves Ziihera® Regimens for First-Line HER2-Positive Gastroesophageal Adenocarcinoma
Zymeworks Inc has announced that its partner Jazz Pharmaceuticals has received approval from the US Food and Drug Administration FDA for two Ziihera zanidatamabhrii treatment regimens
BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA
BeOne Medicines has announced that the US Food and Drug Administration FDA has approved TEVIMBRA tislelizumab in combination with ZIIHERA zanidatamab and chemotherapy
Cycle Pharmaceuticals Launches CAVHANZA™ (Nilotinib) Orally Disintegrating Tablets in the United States
Cycle Pharmaceuticals has launched CAVHANZA nilotinib Orally Disintegrating Tablets ODT in the United States providing a new treatment option for patients with Philadelphia chromosomepositive chronic myeloid leukaemia Ph CML
European Commission Approves DAYBU® (Trofinetide) for Neurobehavioral Symptoms of Rett Syndrome in the European Union
Acadia Pharmaceuticals Inc has received marketing authorisation from the European Commission EC for DAYBU trofinetide for the treatment of neurobehavioral symptoms associated with Rett syndrome in adults and children aged five years and older
Erasca Granted FDA Fast Track Designation for ERAS-0015 in Metastatic Pancreatic Adenocarcinoma
S is designed to inhibit RAS signalling and is being developed as a potential treatment for cancers driven by the RASMAPK pathway The therapy is currently being evaluated in the AURORASErasca
