Industry News
Considerations in Demonstrating Interchangeability with a Reference Biologic Product
Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Monitoring and Control of Inline Dilution Processes
Successful process intensification with inline dilution requires effective monitoring and control.
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.
