Industry News
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
NIIMBL and FDA Partner in Biopharmaceutical Manufacturing
NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Catalent Biologics Announces Long-Term Strategic Agreement to Develop Zolgensma
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
FDA Releases Guidance on Electronic Submissions
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
USP to Provide Free Access to Quality Standards for AACP Students
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
Connecticut Manufacturer Gets FDA Warning Letter
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
US and Europe Reach Mutual Recognition Agreement Goal on Inspections
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
FDA Releases Draft Guidance on Population Pharmacokinetic Analysis
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
FDA Finalizes REMS Guidance
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
FDA Releases Draft Guidance on Using the Inactive Ingredient Database
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
Guidance on the Harmonization of Compendial Standards Published
FDA released draft guidance on using the USP pending monograph process in the drug application process.
Amicus Partners with Catalent on Lysosomal Disease Gene Therapy Programs
Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.
FDA Publishes Guidance on Instructions for Use in Patient Labeling
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
Amicus Therapeutics Enters Strategic Manufacturing Collaboration with Thermo
Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.
Industry Continues to Invest Significantly in UK R&D
New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.
Source of Nucleic-Acid Asymmetry May Advance Gene Therapy
Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.
FDA Announces Draft Guidance for Bioanalytical Method Validation
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
International Survey Uncovers Challenges in Laboratory Workflows
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
FDA Challenges USP Standards for Biologics
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
Sanofi, Google to Develop New Healthcare Innovation Lab
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.
CPI to Showcase Results of Biologic Drug Development Collaboration
Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.
Will Congress Enact Curbs on Drug Pricing?
Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
GSK, University of California Collaborate on CRISPR Technologies
GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.
2019 Michelson Prize Winners Announced
The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.
Industry Publishes a Guide for Companies Working with Patients
ABPI has published a guide for pharmaceutical companies on how to work successfully, collaboratively, and ethically with patients and patient groups, in line with the ABPI Code of Practice.
Taiwan Facility Receives FDA Warning Letter
Vida International received an FDA warning letter after an inspection found quality control violations.
Luxembourg and the Netherlands Added to EU–US Inspections Agreement
The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.
