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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
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Industry News
Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.
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The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.
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Bio/Pharma News
FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.
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The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.
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Regulatory News
The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.
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The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.
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Featured Topics |
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FORMULATION
The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.
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FILL-FINISH
Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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QUALITY/REGULATIONS
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
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WEBCASTS
Ensuring Integrity of Drug Formulation from Development to QC
Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
Learn More
Bulletproof your Supply Chain: Hope for the Best, Prepare for the Worst
Monday, May 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Through Container Verification of Pharmaceutical Raw Materials with the New Agilent Vaya Handheld Raman System
Europe Broadcast: Thursday, May 14, 2020 at 9am EDT | 2pm BST | 3pm CEST
US Broadcast: Thursday, May 14, 2020 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Friday, May 15, 2020 at 8:30am IST | 11am CST | 12pm JST | 1pm AEST
Learn More
Practical Considerations for Bringing Drug Candidates to Phase I Clinical Trial
Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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When Drug Meets Device: How to Assess Compatibility
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More
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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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The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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