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Sartorius Stedim Biotech Launches New Mammalian Cell Bank Services
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
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.
Olon Constructs Fermentation Facility in Italy
Olon began construction of a GMP facility for biologic APIs in Capua, Italy.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
Abcam Acquires EdiGene’s Entire Live Cell Lines and Lysates Portfolio
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
Sartorius Stedim Biotech Launches Single-Use Vessel for ambr 250 Modular Bioreactor
Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.
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.
Catalent Breaks Ground at $112-Million Drug Product Manufacturing Facility
Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
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.
Gilead and Galapagos Announce Global R & D Collaboration
Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.
Boehringer Ingelheim Acquires Immunotherapy Platform
Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.
New Cleanroom Facility Built at ADC Bio
The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.
ADC Therapeutics Closes Series E Financing Expansion
Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.
MES Planned for Cell and Gene Therapy Applications
Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.
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.
JSR Life Sciences Opens Applications Development Facility
The Applications Center of Excellence in Durham, NC, will offer development studies for JSR Life Sciences customers.
Agilent to Acquire BioTek for $1.165 Billion
Agilent Technologies Inc. announced that it signed a definitive agreement to acquire BioTek Instruments, a company that handles the design, manufacture, and distribution of innovative life science instrumentation for $1.165 billion.
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.
