News

Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome

December 27, 2023

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

A Record Year for Disease Elimination

December 26, 2023

WHO provides a look at the world’s health as the agency turns 75.

FDA Publishes Guidance on Real-Word Data

December 21, 2023

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

EMA and FDA Answer Questions About Breakthrough Therapies

December 21, 2023

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

Daiichi Sankyo Partners with Depixus to Accelerate RNA-Targeted Drug Discovery

December 20, 2023

Under a collaboration, Daiichi Sankyo and Depixus will use Depixus’ MAGNA technology to accelerate drug discovery efforts of RNA-targeted therapeutics.

NightHawk Biosciences Shifts into a Pure-Play Large-Molecule CDMO

December 20, 2023

Following the divestiture of its Elusys subsidiary and other non-core assets, NightHawk Biosciences will transform into a pure-play large-molecule CDMO.

Bristol Myers Squibb and SystImmune Enter Global ADC Collaboration Worth Potentially up to $8.4 Billion

December 19, 2023

Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.

EMA Publishes Guide for Use of AI in Medicine Regulation

December 18, 2023

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs

December 15, 2023

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Consent Decree Entered Against Pharmasol

December 15, 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.