Beyond Sterile - The Quiet Complexity of Non-Sterile Outsourcing
Emerging Frontiers in Cellular Immunotherapy
The Missing Middle of Pharma Personalisation
Regulatory Consistency Enables Global Patient Access
How Misaligned Pharma and Diagnostic Timelines Are Slowing Targeted Therapy Access
EDITORIAL SECTION
-
STRATEGY
Strategic Positioning for M&A
The biotechnology sector is characterised by a constant influx of small highly specialised companies
-
RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solutions help reduce contamination risk and lower manual handling
-
CLINICAL TRIALS
Virtual Clinical Trials
Virtual digital and decentralized are all descriptions of the novel ways that using technology changes
-
Bio Pharma
Biosimilars and Biobetters
Biosimilars are biologic medical products that are essentially identical to an original product manufactured
-
MANUFACTURING
Transformative Convergence of AI in Pharmaceutical Manufacturing
The pharmaceutical manufacturing industry is on the cusp of a revolutionary transformation driven by
-
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
-
EXPERT Talk
Pharma's Medical Affairs Bridge: From Field Insights and Stakeholder Needs to Global Scientific Strategy
Medical Affairs has evolved from being primarily a supportive and educational function to becoming a strong strategic partner earlier on Through ongoi...
Advisory Board
.webp "Juris Hmelnickis")
.webp "Eiman Shafa")
KNOWLEDGE BANK
-
Articles
Pharmaceutical Quality Systems in the U.S.: GMP, Quality Control and Manufacturing Compliance
Most people never think about the quality system behind their medicine They open a bottle take a tablet and trust it That trust is built on a huge amount of unglamorous work documentation testing audits and people who say stop the line when something looks off
-
Techno Trends
Glycomine’s GLM101 Receives FDA Breakthrough Therapy Designation
Glycomine has received Breakthrough Therapy designation from the US Food and Drug Administration FDA for GLM an investigational treatment for phosphomannomutase congenital disorder of glycosylation PMMCDG a rare multisystem disorder with no approved therapies
-
Projects
Hovione Opens US$100 milllion East Windsor Pharma Manufacturing Expansion
Pharmaceutical CDMO Hovione has opened a new squarefoot facility at its East Windsor campus in New Jersey completing its current US million US investment programme The expansion doubles Hoviones US spraydrying capacity and strengthens its pharmaceutical development
-
Research Insights
Salivary and serum levels of NT-proBNP, troponin, and high-sensitivity C-reactive protein in patients with heart failure
Saliva has been proposed as a noninvasive biological matrix for cardiovascular biomarker assessment However evidence regarding its agreement with bloodbased measurements in patients with heart failure remains inconsistent
-
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
-
1
Monkey Pox: A viral disease creating trepidation but not pandemic
Parag Tarapada
Nija Patel
Mansi Athalye
After experiencing the pandemic of COVID-19, the advent of Monkeypox- A viral disease in 2022 has fetched the attention of researchers. It is a zoonotic viral disease occurred in various countries cal...
-
2
AI-Powered Clinical Data Management: Improving Quality, Speed, and Regulatory Compliance
Lakshmi
Clinical trial data volumes have roughly tripled while database lock timelines have lengthened, and headcount can no longer close that gap. This article examines how artificial intelligence is reshapi...
-
3
Importance of Advanced Analytical Tools - Nitrosamines in Pharmaceutical Drug Substances and Drug Products
Bhaskar Vallamkonda
Nitrosamine impurities pose carcinogenic risks, prompting global regulatory concern. This review highlights recent advances in LC-MS/MS methods for detecting trace levels of nitrosamines, emphasizing...
-
4
Cancer Cell-Membrane-Coated Nanocarriers in Cancer Diagnosis and Treatment: Frog-leaping into the future
Gargi Digholkar
Jainam Karsiya
Dileep Kumar
Ryan Varghese Mathew
Cancer is the leading cause of mortality worldwide and is generally attributed to limited treatment options. While nanotechnology is projected to revolutionize the treatment landscape, it comes with i...
-
5
Boost Your Pharma Conference ROI: Proven Tactics to Increase Qualified Leads
Kate Williamson
Pharma conferences generate volume, but not always value. This article presents some viable measures to enhance the ROI of pharma conference through qualified lead generation process, targeted pre-eve...
press releasesRead more...
FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of Non-Small Cell Lung Cancer
Trethera Corporation Trethera a clinical stage biopharmaceutical company developing firstinclass therapies for cancer and autoimmune diseases announced today that the US Food and Drug Administration
Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients
Edwards Lifesciences NYSE EW today announced that the US Food and Drug Administration FDA has approved the AUTUS SizeAdjustable Valve a surgical pulmonary valve designed specifically
Genentech’s Fenebrutinib Is the First BTK Inhibitor to Receive U.S. FDA Filing Acceptance in Both Relapsing and Primary Progressive Multiple Sclerosis
Genentech a member of the Roche Group SIX RO ROP OTCQX RHHBY announced today that the US Food and Drug Administration FDA has accepted the companys New Drug Application NDA
MedImpact Launches Claria™, a Distinctively New Approach to Delivering Pharmac Benefits
MedImpact the nations largest independent pharmacy benefit and health solutions company today introduced Claria an industryfirst approach that transforms PBM economics by giving plan
Events Read more...
05 - 06
Oct 2026ISPSAI France 2026
Paris, France
05 - 08
Oct 202616th World CB & CDx Summit 2026
Boston, MA, USA
12 - 14
Oct 2026Pharmaceutics 2026
Village Hotel Changi, Singapor...
12 - 13
Oct 20262nd International Conference on Drug Discovery
Village Hotel Changi, Singapor...
21 - 23
Oct 2026Drug Formulation & Drug Delivery 2026
Paris, France
21 - 22
Oct 2026Advance Clinical Trials and Research 2026
Paris, France
22 - 23
Oct 2026PDA Aseptic Symposium 2026
Congress Square Nakanoshima, O...
26 - 28
Oct 2026ACHEMA Middle East 2026
RICEC, Riyadh, KSA, Saudi Arab...
LATEST NEWSRead more...
Bayer to invest $2.2 billion in new US pharmaceutical manufacturing site
Bayer plans to invest billion in a new pharmaceutical manufacturing site in New Albany Ohio in the United States The project is part of the companys longterm growth strategy and will support its focus on innovation and patient access in the US pharmaceutical market
Italfarmaco and JCR Pharmaceuticals sign exclusive licence agreement for Hunter syndrome therapy
Italfarmaco and JCR Pharmaceuticals have entered into an exclusive licence agreement to develop and potentially commercialise JR in the United States Europe and Latin America subject to regulatory approval
AbbVie Partners with Valkai to Expand AI Use in Clinical Development
AbbVie has partnered with Valkai a life sciences artificial intelligence AI platform to expand the use of AI across selected areas of clinical development
Merck Enters into Exclusive Global License Agreement with SciBrunch Therapeutics for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor
Lifecore Biomedical has entered into a definitive agreement to be acquired by Webster Equity Partners in a transaction valued at up to million subject to the achievement of certain performance milestones
Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of YUSIMRY®, a Biosimilar to Humira®
Meitheal Pharmaceuticals has announced that the US Food and Drug Administration FDA has approved a highconcentration formulation of YUSIMRY adalimumabaqvh an interchangeable biosimilar to Humira
Merck Enters into Exclusive Global License Agreement with SciBrunch Therapeutics for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor
Merck known as MSD outside of the United States and Canada and SciBrunch Therapeutics Co Ltd SciBrunch today announced that they have entered into an exclusive global license agreement for SPR an investigational preclinical oral KRAS GD ON inhibitor
