Thursday, January 28, 2021 Daily Archives

Novartis cracks on with tech transfer with eye for US Leqvio approval

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Novartis says transferring the manufacturing of Leqvio (inclisiran) to its own site in Austria is not related to documentation issues at its CDMO. Novartis reported its Q4 financials this week, detailing that it is working with the US FDA to minimize further delays in the approval of siRNA therapy, Leqvio. While the therapy has been approved in Europe, a complete response letter (CRL) received in December highlighted problems at contract development manufacturing organization (CDMO) CordenPharma in Italy. Novartis now hopes…

January 28, 2021

COVID vaccines: Why J&J could have market advantage over others

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Tried and tested technologies, a single-dose regimen, and a simple cold-chain infrastructure place Johnson & Johnson’s potential COVID-19 vaccine at an advantage over the current approved offerings. Johnson & Johnson (J&J) has said it plans to present results of its COVID-19 candidate JNJ-78436735, also known as Ad26.COV2-S, recombinant, in the next few days. “Being in the final stages of a robust 45,000-person study, analytics will be completed, and we plan to report out the results by early next week,†CFO…

January 28, 2021

Ajinomoto: Deal for Humanigen’s COVID MAb will save time and money

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Ajinomoto Bio-Pharma Services says an expanded fill/finish contract for Humanigen’s COVID-19 antibody candidate lenzilumab will provide cost and time savings. This week the contract development and manufacturing organization (CDMO) said it “will assume a key role in simplifying the supply chain efforts for Humanigen by providing drug product aseptic fill finish services at its San Diego facility to support continued clinical trial efforts through potential commercialization.†Ajinomoto spokeswoman Stephanie Harrison told us, “We will provide streamlined and quality fill finish…

January 28, 2021