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Top Stories
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.
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In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.
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Industry News
A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.
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Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
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Biopharma News
Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.
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Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.
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Supplier News
The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.
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The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.
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Regulatory News
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
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The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
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QUALITY SYSTEMS
A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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September 3–4, 2019
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The editors examine the technology, practices, and regulatory approval questions facing
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