Top Stories
Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.
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The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
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Industry News
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
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Scientists at Washington University School of Medicine in St. Louis have developed a method that could help increase the long-term effectiveness of gene therapy.
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Supplier News
Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.
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The event, taking place on June 6–7, 2018 in Clinton and Somerville, NJ, will focus on the latest melt extrusion and granulation technologies for pharmaceutical and nutraceutical products.
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Bio/Pharma News
The companies plan to advance programs for dementia and other neurological conditions.
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As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.
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Regulatory News
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
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FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
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SUPPLY CHAIN
The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.
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DRUG DEVELOPMENT
Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.
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VACCINES
This article discusses the potential of using high-productivity membrane chromatography to achieve intensified and flexible virus manufacturing.
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STANDARDS & REGULATIONS
Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.
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Events
May 29–30, 2018
June 4–7, 2018
June 14–15, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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