Digital Quality Management Systems as Strategic Enablers of Patient-Centric Manufacturing Excellence
Single Use Technologies (SUT) in Pharmaceutical Manufacturing
Energetic Chemistry in Pharma
Navigating the U.S. CDMO Industry
The Increasing Importance of Manufacturability in API Development
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
Global Clinical Trial Strategies: Navigating Regulatory Complexity and Operational Excellence
US biopharmaceutical companies have spent two decades treating global trial expansion as an arithmetic problem more countries more sites more patients faster enrollment lower cost per subject That arithmetic no longer holds Between the start of and the start of essentially every regulatory jurisdiction that matters to an American sponsor has rewritten or is rewriting the rules governing
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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
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
Twin-Screw Melt Granulation: A Solvent-Free, Single-Step Solution for Enhancing Drug Solubility
Dinesh Nyavanandi
Nithin Vidiyala
Twin-screw melt granulation (TSMG) is a solvent-free, single-step, and scalable technology enhancing solubility and bioavailability of poorly water-soluble APIs. By improving dissolution, process effi...
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2
AI-Driven Clinical Development: Transforming Biopharma Decision-Making
Lakshmi
Artificial intelligence has moved from pilot projects into the core machinery of American clinical development, yet adoption has outrun demonstrable impact. This article examines where AI genuinely ch...
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3
Role of Medical Affairs in HCP Engagement: Effective Strategies and Tools for Success
Kate Williamson
The changing healthcare ecosystem has enhanced the significance of Medical Affairs in achieving meaningful engagement of HCPs. In this article, the authors will discuss how strategic communication, di...
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4
Harnessing Digital Biomarkers and Wearables: Transforming Clinical Research
Kate Williamson
Digital biomarkers and wearables are revolutionizing clinical research by providing real-time data on patients' health. They offer insights into physiological and behavioral changes, and improve t...
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5
Key Challenges in Drug Manufacturing and How to Overcome Them
Kate Williamson
Some of the issues intrinsic to drug manufacturing include the capability to maintain quality, regulatory requirements, cost, supply chain issues, expansion, information technology interface, and the...
press releasesRead more...
Chloe Kim Teams Up with Qelbree®, the #1 Prescribed Branded Non-Stimulant ADHD Treatment*, to Help Empower People Navigating ADHD
Professional snowboarder Chloe Kim is partnering with Supernus Pharmaceuticals as a compensated ambassador to discuss her journey with attentiondeficithyperactivity disorder ADHD and her treatment plan with Qelbree
BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines
BeOne Medicines Ltd Nasdaq ONC HKEX SSE a global oncology company today announced a voluntary agreement with the US Government to expand access to innovative cancer
Lexicon Announces New Post Hoc SOLOIST-WHF Analysis Demonstrating Consistent Sotagliflozin Results Across Baseline Blood Pressure Levels in Patients with Recent Worsening Heart Failure
Lexicon Pharmaceuticals Inc Nasdaq LXRX today announced results from a post hoc analysis of the Phase SOLOISTWHF trial evaluating the efficacy and safety of sotagliflozin across the spectrum
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
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 PharmaEssentia’s BESREMi for adults with essential thrombocythaemia
PharmaEssentia USA Corporation a subsidiary of PharmaEssentia Corporation has received approval from the US Food and Drug Administration FDA for BESREMi ropeginterferon alfabnjft to treat adults with essential thrombocythaemia ET a rare form of blood cancer
Transcat expands biomedical calibration business with Southeastern Biomedical acquisition
Transcat Inc has acquired privately held Southeastern Biomedical Associates Incorporated strengthening its biomedical calibration services and expanding its presence across the southeastern United States
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
