Newsletter | January 9, 2024

01.09.24 -- A Brief Guide For Vaccine Companies Working Toward FDA Approval For The First Time


A Brief Guide For Vaccine Companies Working Toward FDA Approval For The First Time

This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.


SimpliFiH Solutions For Accelerated Pharmaceutical Development

Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

Continuous Flow Techniques For Fine Chemical Manufacturing

Explore the advantages and challenges of continuous flow processes and the concept of mini-monoplant technology, along with examples that demonstrate the versatility of continuous processing.

mRNA-Lipid Nanoparticles Circumvent Viral Vector Limitations

Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller-scale production and the low risk of immunogenicity.

Following The Science To Develop Best-In-Class Cancer Drugs

As innovative cancer therapeutics continue to enter the clinical trial pipeline, some developers are shifting their focus toward developing drugs that are safe and efficacious with minimal toxicity.


Diakonos Oncology Completes Phase 1 Glioblastoma Trial Recruitment

Better Therapeutics Submits Request For FDA Breakthrough Device Designation

Study Demonstrates Potency Of Synthetic Antibiotic Against Serious Chronic Infections

New Method Illuminates Druggable Sites On Proteins

Demystifying A Key Receptor In Substance Use & Neuropsychiatric Disorders

Angle PLC Contract Announcement With Eisai Inc.

Junshi Biosciences Announces Approval Of The sNDA For Toripalimab

BridGene Biosciences Announces Strategic Collaboration With Galapagos

MediLink Announces Worldwide Collaboration & License Agreement With Roche

BridgeBio Announces FDA Clearance Of IND Application For BBO-8520

Remix Therapeutics Enters Collaboration And License Agreement With Roche


Cell Therapy Product Characterization Services

ADHD Awareness: How Can STARMAP® Online Guide The Way?