Biogen says ‘significant capacity’ allocated to aducanumab could impact 2021 results if the potential Alzheimer’s disease treatment is not approved. At the end of last month, Biogen announced that the US Food and Drug Administration (FDA) would delay its decision on aducanumab by three months, meaning that a decision is now expected on approval by 7 June of this year. The monoclonal antibody (mAb) treatment could become the first therapy approved for Alzheimer’s disease to change the course of the…

The deal is the first of potentially ‘multiple’ such agreements to support manufacture of COVID-19 vaccines. The agreement sees Novartis provide aseptic manufacturing services from its Stein, Switzerland, facility for the production of Pfizer and BioNTech’s COVID-19 vaccine. Novartis will provide the services under a contract manufacturing agreement that sees the company take bulk mRNA active ingredient from BioNTech and fill this into vials, before shipping the vials back to BioNTech for distribution. The Swiss company announced that it would…

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…

Professionals suggest that manufacturing capacity concerns in the cell and gene therapy space have lessened but a lack of adequate staffing is a growing fear. Conversation’s like this usually happen on the floor of exhibition centers. However, while face to face events are months away, BioProcess Insider has turned to LinkedIn to explore online discussions. Last week, vice president of Business Development at Cellares, Mark Flower posted “Has the industry reached the point that manufacturing capacity concerns have lessened or…

Samsung Biologics says virtual capabilities and supply chain management led to a successful year, despite the global pandemic. John Rim, the newly appointed president and CEO of Samsung Biologics, used a presentation at the JP Morgan Healthcare Conference to reveal that the company had signed $1.7 billion (€1.4billion) in contracts during 2021, a record for the company. Explaining how the company had managed to achieve this, Rim called attention to Samsung Biologics’ capacity for virtual exhibition halls and live-streaming tours.…