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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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Neurocrine will develop and commercialize seven of Takeda’s pipeline programs, including three clinical-stage assets for schizophrenia, treatment-resistant depression, and anhedonia.
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Industry News
The decision was made in order to give exhibitors enough time to adjust their plans in the wake of the continuing spread of COVID-19.
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The products are being recalled because of missing graduation marks on the dosing cups
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Supplier News
The company will invest $75 million into its Canton, MA, facility to expand its viral vector, gene therapy, and contract development and manufacturing capabilities.
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Bio/Pharma News
Catalent will develop two oral dosage forms of ViralClear’s broad-spectrum anti-viral agent as a possible treatment for adults with COVID-19.
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Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.
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SCHOTT Fast Track Kits – small quantities for easy R&D
Small quantity access to high quality primary packaging components can be challenging. But this is about to change.
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Regulatory News
The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.
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An instruction has been issued to all those performing clinical trials using hydroxychloroquine to treat or prevent COVID-19 to stop recruitment of any new patients by the MHRA in the UK.
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Featured Topics |
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QUALITY/REGULATIONS
Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
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SUPPLY CHAIN
The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
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QUALITY SYSTEMS
Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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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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