Friday, July 17, 2020 Daily Archives

Catalent expands contract with Humanigen for COVID-19 MAb

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Catalent will provide end-to-end services to support lenzilumab in a Phase III study in COVID-19 patients. In May, Catalent announced it was clinically supporting Humanigen’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody lenzilumab for a Phase III clinical trials for COVID-19. This week, the contract development and manufacturing organization (CDMO) says it has expanded its work with Humanigen to include full end-to-end services for the candidate. “Humanigen and Catalent have been working together since 2007, but shifted focus earlier…

July 17, 2020

With capacity assured and platform proven, hopes grow for J&J COVID vaccine

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J&J is confident of the success and supply of its COVID-19 vaccine candidate after securing manufacturing capacity and receiving approval of Ebola vaccines based on the same adenovector technology. Johnson & Johnson’s candidate – SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant – is set to enter Phase I/IIa studies later this month (see textbox). It is one of a number of coronavirus vaccines in development but according to the firm, the candidate’s potential for success has been bolstered by the verification of the…

July 17, 2020

WHO drafting regulatory convergence white paper on cell and gene therapies

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Regulators in high-income countries have a responsibility to help health authorities in low- and medium-income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director Peter Marks. The World Health Organization plans to soon issue a white paper proposing a harmonized regulatory framework for cell and gene therapy products, according to Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation…

July 17, 2020