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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.
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Industry News
A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.
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A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.
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Exclusive Interview from AAPS:
A Comprehensive Analysis Into Disintegration Mechanisms
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View Now /
Sponsored by: JRS Pharma |
Supplier News
Remote, machine health monitoring services reduce the need for on-site visits.
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The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.
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Bio/Pharma News
Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.
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The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.
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Regulatory News
The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.
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Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).
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Featured Topics |
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MANUFACTURING
Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.
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ANALYTICS
Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.
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OUTSOURCING
Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.
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QUALITY/REGULATIONS
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
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WEBCASTS
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
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
Learn More
Comprehensive Analysis into Disintegration Mechanisms: How Reliable Are Textbook Recommendations?
Wednesday, June 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More
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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