Monday, February 18, 2019 Daily Archives

Immunomedics: Data integrity and quality issues cited in FDA 483

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The US FDA found antibody-drug conjugate developer Immunomedics to have manipulated data during an inspection last year. In January 2019, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Immunomedics for its antibody-drug conjugate (ADC) candidate sacituzumab govitecan, being developed to treat breast cancer. The firm said at the time: “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need…

February 18, 2019

FDA guidelines aim to improve quality and lower costs

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The US FDA has issued draft guidance intended to promote innovation in pharmaceutical development and manufacturing. Entitled ‘Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry,’ the draft guidance has been produced by the US Food and Drug Administration (FDA) to informally recognize voluntary consensus standards relating to pharmaceutical quality for products under the jurisdiction of the Center for Drug Evaluation and Research (CDER). “The overall goal of this program is to promote development…

February 18, 2019

Photo opp: How imaging companies focused on cell and gene therapies

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Fujifilm and Nikon say their respective moves into regenerative medicine came from a rich heritage in imaging services such as X-rays and microscopes. In January 2018, Fujifilm Corporation, through its contract development and manufacturing organization (CDMO) business Fujifilm Diosynth Biotechnologies (FDB), opened an 80,000 square-foot facility in Texas for the production of clinical and commercial gene therapies. Months later it announced plans to expand the site, adding gene therapy fill/finish capabilities. Investments in such an innovative field as gene therapies…

February 18, 2019