American Pharmaceutical News In Review

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June 24, 2024

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	Industry News

Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ®
Valneva, a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, ... read more »

BMS Announces FDA Accelerated Approval of KRAZATI® in Combination with Cetuximab for Colorectal Cancer
Bristol Myers Squibb announced that the FDA granted accelerated approval for KRAZATI® (adagrasib) in... read more »

BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate for Prostate Cancer
BioNTech SE and Duality Biologics Co., Ltd. announced that the FDA granted Fast Track designation ... read more »

FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
Today, the US FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene ... read more »

	QC Corner

Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection
In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... read more »

	Cell and Gene Therapy Circuit

Advances in Electroporation Technology: Cell & Gene Therapy Development Innovations from MaxCyte
Join Mike Auerbach, editor-in-chief at American Pharmaceutical Review and Debra Barberini, PhD, ... read more »

	Infographic

Using the Carcinogenic Potency Categorization Approach (CPCA) to Classify N-nitrosamine Impurities
This infographic details the features and benefits of selecting appropriate NDSRI reference samples. read more »

	Featured Articles

		mRNA and Oligonucleotides Process and Manufacturing Gene therapy has emerged as a promising therapeutic for the treatment of genetic and acquired diseases. Gene transfection into target cells using ... read more »

		Stability Lifecycle: An Application of ICH Q12 to Manage the Pharmaceutical Stability Program Expiration dating and storage conditions are required on the label for all pharmaceutical products. To establish a drug product’s storage condition ... read more »

	Featured Video

On-Demand Webinar: What's the Impact of Fluoropolymer Use on PFAS Migration in Cell & Gene Therapy
In this webinar you’ll receive insight on common Extractable & Leachable (E&L) regulatory guidance gaps in cell & gene therapy (C>) applications. watch »

On-Demand Webinar: Analytical Considerations for the Development of Protein Therapies
This webinar will cover key aspects to consider for CMC Testing for Protein-Based Therapeutics watch »

	Featured Products

PROSOLV® SMCC 90 LM - Silicified Microcrystalline Cellulose
JRS Pharma PROSOLV® SMCC 90 LM is a special low moisture grade of SMCC for use in direct compression of water ... learn more »

GS Camtain® Dust Collector for Pharmaceutical Applications
Camfil Air Pollution Control (APC) The Gold Series (GS) Camtain dust collector for pharmaceutical applications can be used for tablet ... learn more »

Sterisart® Universal Sterility Testing Pump
Sartorius Lab Instruments GmbH & Co.KG A Sterility Testing Pump for the Modern Lab The new Sterisart® Universal Pump | Gen 4 is engineered ... learn more »

	Featured Whitepaper

Whitepaper: A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs
New molecule formats are gaining momentum in today’s market. Read this white paper to: Gain insights into the diverse and complex structures of new molecular formats, often encompassing multiple ... read more »

Whitepaper: Drug Substance & CMC Development Tool Box - Proactive Chemistry, Manufacturing, and Controls (CMC) Development
Small molecule development programs are subject to a range of technical and strategic challenges from procurement and early development of the target candidate molecule, selection of dosage form and ... read more »

	More Products

Abbemat 200 Economy Line Refractometer Learn More
Arium^® Mini Ultrapure Water Systems Learn More
BENCHTOP Manifold Freeze Dryer Learn More

	Directory Categories

Excipient Search Search More

Mycoplasma Detection Assays Search More

Pharmaceutical Tubing and Hoses Search More

	Events

Controlled Release Society (CRS) Annual Meeting
Bologna, Italy – 07/08/2024
The Controlled Release Society (CRS) Annual Meeting is a premier international event that brings together experts and researchers in the field of ... event details »

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