Industry News
USP Submits Comments to FDA on Biologics Naming Guidance
USP responds to FDA's draft guidance on the naming of biological products.
Biosimilar Development Continues to Challenge FDA and Industry
Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.
Revenues from Pfizer’s Vaccine Business Increase
According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.
EMA Recommends Advanced Therapy for Melanoma
Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.
FDA Releases Draft Guidance on Packaging of Injectables
The agency provides terms and recommendations for packaging and labeling of injectable medical products.
FDA Assesses Overview of Combination Products
The agency gives an update on the regulation of combination medical products.
Meet the 2015 CPhI Pharma Awards Winners
Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.
NIH Dedicates Funds to Carbohydrate Science
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.
Cell Therapy Catapult Launches Cell History File
The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.
FDA Releases Guidance on Labeling
The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.
PDA Releases Report on Passive Thermal Protection Systems
The PDA report discusses qualification and operational handling of passive thermal protection systems.
Parasitic Disease Drug Researchers Awarded Nobel Prize
Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.
Emerging Life-Sciences Markets: New Partnerships, New Competitors
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.
DTU Announces the Creation of a Massive Protein Characterization Database
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.
Democrats Want to Subpoena Valeant Pharmaceuticals Over Drug Price Increase
Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.
FDA Names Industry Veteran as Director of Quality Office
Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.
FDA Releases Guidance on Generic-Drug Development
The agency releases guidance on controlled correspondences related to generic-drug development.
USP Previews New Compounding Standards
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
Compounding Pharmacy Issues Recall
US Compounding, Inc. issues voluntary recall of all sterile products.
FDA Promotes Its Scientific Mission
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.
NIH Awards Grants for Genomics Research
Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.
EMA CHMP Chair Re-elected
Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
New Zealand Manufacturer Cited for CGMP Violations
FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.
FDA Cites India API Facility For CGMP Violations
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
Johns Hopkins University Debuts New Protective Suit for Ebola Outbreaks
The protective suit was recently honored by Fast Company’s 2015 Innovation by Design Awards.
Confirmation for Califf?
The White House nominates Robert Califf to head FDA, but will he be confirmed?
Rob Califf Selected to Fill FDA Commissioner Post
President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.
FDA Issues Final Elemental Impurities Guidance
FDA publishes the final Q3D Elemental Impurities guidance.
EMA Sets Up Workshop on Orphan Drugs
The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.
