TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.
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Industry News
Data and analytics company GlobalData announced that there is a strain on the global biopharma industry’s supply chain due to the ongoing outbreak of COVID-19.
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In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.
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Biopharma News
The companies will use CytomX’s Probody therapeutic technology platform and its proprietary bispecific formats and CD3 modules.
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The company announced the status of new and ongoing clinical trial activities during the COVID-19 pandemic.
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Supplier News
Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.
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ProBioGen will facilitate the development of Immunogenesis’ monoclonal antibody candidate and will be responsible for manufacturing the drug at its new facility in Berlin, Germany.
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Regulatory News
FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.
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FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.
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FEATURED TOPICS |
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FORMULATION
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
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QUALITY SYSTEMS
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
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WEBCASTS
Simple and Effective Methods for Purification and Determination of Molecular Weight of DMT-on and DMT-off Oligonucleotides
Wednesday, April 22, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Multi-Level Workflows for Quantitative N-Glycan and Sialic Acid Analysis of Biotherapeutics
Europe & US Broadcast: Tuesday, March 31, 2020 at 9am EDT | 2pm BST |3pm CEST
US Broadcast: Tuesday, March 31, 2020 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific: Wednesday, April 1, 2020 at 8:30am IST | 12pm JST | 2pm AEDT
Learn More
Implementing Attribute Monitoring Analyses for Biopharmaceutical Development and QC
Wednesday, April 29, 2020, 9am EDT| 2pm BST| 3pm CEST
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
Interphex 2020 has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020.
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
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eBook
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In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.
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