Category: Research and Development

January 18, 2022

Ori Biotech, which is on the cusp of launching an innovative process for manufacturing cell and gene therapies (CGTs), tallied more than $100 million in its latest funding round. The company will use the money to add key personnel in […]

January 18, 2022

Stanford University spinout N1 Life has formed a joint venture to further its drug delivery ambitions. The startup is teaming up with Accuredit Therapeutics to create a joint venture, Napoltec, focused on novel drug delivery systems and the progression of […]

January 18, 2022

Samsung Biologics announced on Jan. 12, 2022 that it plans to start building a new facility (designated Plant 5) at Songdo in Incheon, South Korea, this year. The facility will offer manufacturing for multi-modal products, including cell and gene therapies […]

January 14, 2022

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU). The Aim of Accelerating Clinical Trials in the EU (ACT EU) […]

January 12, 2022

In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination […]

January 12, 2022

Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), but the draft decision means broad coverage of the drug will have to wait for […]

January 10, 2022

One of the strongest trends in clinical trials is patient centricity, which is to say, making the patient experience as easy and accessible as possible. During the height of the COVID-19 pandemic, this became even more of a focus because […]

January 3, 2022

One year ago, the biotechnology sector was in the middle of a record run. The successful development of coronavirus vaccines and drugs had helped slow the pandemic and propelled investment into new companies going public at a historic rate. Biotech […]

December 28, 2021

Anton Middelberg, PhD, deputy vice-chancellor and vice-president of research at the University of Adelaide in Australia, believes industry reluctance to go continuous reflects the traditional focus on batch-mode production and, in some areas, the technical challenges. “The complexity in continuous […]

December 22, 2021

The data are clear: White patients are taking up the majority of clinical trials. About 130 million Americans across various races are “being somewhat ignored, [or] deprioritized, in clinical trials” that support regulatory approval, said Yele Aluko, M.D., chief medical […]

December 21, 2021

Continuous processing, for decades an essential characteristic of advanced large-scale manufacturing, has been adopted slowly for mammalian cell-based processes, and even more haltingly for microbial fermentations. In a recent paper in Frontiers in Bioengineering and Biotechnology, lead author Christoph Herwig, […]

December 17, 2021

A total 35 percent of healthcare professionals worldwide believe that digital transformation — involving the use of technologies such as artificial intelligence (AI), big data, cloud computing, application programming interfaces (API) and digital platforms — would improve both pre-clinical and […]