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Top Stories
In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.
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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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Industry News
FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.
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The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.
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The 2019 PDA/FDA Joint Regulatory Conference will highlight the evolving regulatory landscape and provide insight into how global companies are addressing regulatory challenges. Hear directly from senior FDA officials about program-specific initiatives and compliance updates. There will also be networking opportunities and an exhibition showcasing products and services to help improve your company's product quality and manufacturing processes.
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Supplier News
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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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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Bio/Pharma News
The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.
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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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Regulatory News
The US Senate and the US Pharmacopeial Convention debate monographs for biologics.
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The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.
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ANALYTICS
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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SCALE UP
Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.
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PEER-REVIEWED RESEARCH
Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
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Events
September 10–11, 2019
September 16–18, 2019
September 18–20, 2019
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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