Industry News

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

The project seeks to index the properties of various proteins in solution and create a home for data on the performance of product excipients with their active substances.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

US Compounding, Inc. issues voluntary recall of all sterile products.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

The protective suit was recently honored by Fast Company’s 2015 Innovation by Design Awards.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

Pharma scientists announced for AAPS executive council and section leadership positions.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.