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Category: Research and Development


Manufacturing, Research and Development

Ori Biotech reaps $100M in series B round to help launch innovative cell manufacturing tech

January 18, 2022

Via: FiercePharma

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 […]


Manufacturing, Research and Development

Stanford spinout forms drug delivery joint venture with Chinese biotech

January 18, 2022

Via: FiercePharma

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 […]


Manufacturing, Research and Development

Samsung Biologics to Construct New Manufacturing Facility for Next-Gen Vaccines and CGT

January 18, 2022

Via: Biopharm International

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 […]


Clinical Trials, Research and Development

Accelerating Clinical Trials in the EU (ACT EU) initiative launch

January 14, 2022

Via: European Pharmaceutical Review

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) […]


Clinical Trials, Research and Development

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

January 12, 2022

Via: Biopharm International

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 […]


Clinical Trials, Research and Development

Medicare limits Aduhelm coverage to clinical trial participants

January 12, 2022

Via: Pharmaphorum

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 […]


Clinical Trials, Research and Development

Leveraging print and digital communications for patient-centric clinical trials

January 10, 2022

Via: Biopharma Dive

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 […]


Clinical Trials, Research and Development

10 clinical trials to watch in the first half of 2022

January 3, 2022

Via: Biopharma Dive

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 […]


Biotech, Industry, Manufacturing, Research and Development

Industry Warming to 24/7 Production

December 28, 2021

Via: Genetic Engineering and Biotechnology News

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 […]


Clinical Trials, Research and Development

2022 forecast: Pharma has the tools. Will clinical trials be less white in 2022?

December 22, 2021

Via: FierceBiotech

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 […]


Manufacturing, Research and Development

Continuous Operations in Microbial Biomanufacturing

December 21, 2021

Via: Genetic Engineering and Biotechnology News

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, […]


Clinical Trials, Research and Development

Digital transformation will improve clinical trial process, say experts

December 17, 2021

Via: European Pharmaceutical Review

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 […]