Jul
27
2020

Potential COVID-19 cell therapy treatments in development

BioWorld

Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases. In an Alliance for Regenerative Medicine (ARM) webinar on the topic, Michael Lehmicke, Director, Science and Industry Affairs at ARM, noted that developers are utilizing mesenchymal stem cells (MSCs) and other stromal cells to treat ARDS caused by COVID-19.

Jul
24
2020

Stakeholders Seek Increased User Fee Support for Biologics

PharmTech.com

At the public meeting to kick off negotiations for renewing the Prescription Drug User Fee Act (PDUFA) before the current program expires in September 2022, patient advocates, research experts, and industry similarly called for more user fee revenues to support CBER programs to advance these innovative therapies.

Jul
22
2020

Shattering barriers toward clinically meaningful MSC therapies

Science Advances

More than 1050 clinical trials are registered at FDA.gov that explore multipotent mesenchymal stromal cells (MSCs) for nearly every clinical application imaginable, including neurodegenerative and cardiac disorders, perianal fistulas, graft-versus-host disease, COVID-19, and cancer. In this review, we discuss the major clinical challenges with MSC therapies, the details of these challenges, and the potential bioengineering approaches that leverage the unique biology of MSCs to overcome the challenges and achieve more potent and versatile therapies.

Jul
22
2020

Pharmaceutical Strategy Could Save European ATMP Development

Pink Sheet

The European Commission’s forthcoming Pharmaceutical Strategy could help stop advanced therapy medicinal product (ATMP) development moving away from the EU if it removes obstacles that impede access to and development of such products, says the Alliance for Regenerative Medicine.

Jul
20
2020

Stem Cells For COVID-19: Promising Platform With A ‘Dark Side’

Pink Sheet

The COVID-19 crisis could be a proving ground to legitimate the still early-stage technology of mesenchymal stem cell therapy, but only if clinical trials are of high quality – blinded and randomized – in a context of regulatory clarity.

Jul
16
2020

Regulation of advanced therapy medicinal products in the EU

Regulatory Focus

Advanced therapy medicinal products include cell therapies, gene therapies, and tissue-engineered products. These highly complex treatments differ from traditional medicines, both in how they are made and administered and in the type of benefits they may provide. These are products for which regulations were established relatively recently and that present challenges for regulatory agencies on how to best they should be regulated within the existing regulatory framework.

Jul
07
2020

BioWorld News - July 7, 2020

BioWorld

The Alliance for Regenerative Medicine (ARM) in Brussels published its response to the EU Pharmaceutical Strategy Roadmap, which is designed to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. While ARM welcomes the Roadmap’s recognition of the wider industry’s contribution to the EU economy and its focus on ensuring patients’ access to safe, state-of-the-art therapies, the Alliance wants to ensure a continued pathway for the EU to benefit from innovative and life-changing advanced therapy medicinal products.

Jul
04
2020

Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19

Cell Stem Cell

In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for COVID-19. Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for COVID-19.