Articles

Gyros’ new titer kit identifies adeno-associated virus serotype 9 in vector-based cell and gene therapy manufacturing.

Gyros Protein Technologies Announces New Titer Kit 

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.

FDA Grants MarzAA Orphan Drug Designation 

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

FDA Approves AbbVie’s Qulipta

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

USP Publishes General Chapter 1220 of Analytical Procedure Life Cycle

CuriRx’s CuriLytics platform is a mass spectrometry instrument that will support complex biotherapeutics development.

CuriRx Launches CuriLytics Platform

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

FDA Removes Clinical Hold on Phase I/II Study of Angelman Syndrome Treatment

KSL Biomedical announced their expansion into Canada with the acquisition of Pulse Scientific and the incorporation of KSL Biomedical Canada.

KSL Biomedical Acquires Pulse Scientific, Expanding Laboratory and Assay Capabilities 

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

Only 10% of Americans Understand the Drug Development Timeline, Survey Finds

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

FDA Caught in the Political Crossfire

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

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