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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
USP technical advisors will offer assistance to drug developers to ensure material quality and testing.
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Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.
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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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Enhancements to Augury’s AI-based machine health platform include new capabilities and collaboration tools for personnel working remotely.
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Bio/Pharma News
Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.
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The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.
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Regulatory News
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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The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.
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Featured Topics |
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MANUFACTURING
The growing interest in developing cell and gene therapies has prompted industry investment to grow manufacturing capacity.
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REGULATORY
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
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PRODUCT/SERVICES PROFILES
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PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community.
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VAI’s manufacturing and testing operations mirror current GMP/GLP standards.
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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.
Validation University has been rescheduled for August 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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eBOOKS
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In Pharmaceutical Technology's ongoing 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, building a quality culture, and essentials for DOE and QRM.
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