Tag: clinical trials

FDA, Regulations

FDA Agrees to Use of New Manufacturing Process for Nomacopan in Clinical Studies

January 19, 2022

Via: Contract Pharma

Akari Therapeutics, Plc, a late-stage biopharmaceutical company focused on therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, has announced that the U.S. Food and Drug Administration ( FDA ) has agreed, […]

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 […]

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 […]

Cell and Gene Therapy, Industry

Avrobio stops work on rare disease gene therapy after unexpected study results

January 4, 2022

Via: Biopharma Dive

Fabry is one of several dozen diseases known collectively as lysosomal storage disorders, all caused by genetic breakdowns in how the body’s cells process complex fats or sugars. Treatment, when it’s available, usually involves infusions of the digestive proteins that […]

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 […]

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 […]

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 […]

Industry, Vaccines

CDC eyes safety of J&J COVID jab as EU backs booster

December 16, 2021

Via: Pharmaphorum

A Centres for Disease and Control Prevention (CDC) advisory committee is scheduled to meet today to discuss the new results, according to a Washington Post report, which point to continued rates of blood clots among people taking the vaccine. The […]


FDA sets April date for verdict on Incyte’s vitiligo drug

December 15, 2021

Via: Pharmaphorum

The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year. If approved, Opzelura would provide […]