Articles

Sudarshan Hebbar, CMO of CalciMedica, reveals how the FDA, ethics committees, and safety consortia have responded to helping to advance the application of novel therapeutics towards COVID.

A Journey: Biotech, FDA, and Safety Committee Responses to COVID 

The COVID-19 pandemic has pushed several focus areas to the forefront of the industry.

Observations on CTTI’s Vision for Clinical Trials in 2030

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Europe's research ministers are will meet to attempt to reach agreement on European Union research plans for the next seven years, including a cluster devoted to a broad range of health goals that range from general objectives to subjects of more specific interest to the community.

Europe Edges Towards a Health Research Plan

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available. 

Europe's COVID Vaccine Bids Still Veiled in Secrecy

Despite the rush for an effective COVID-19 therapy, biotech industry leaders insist rigorous research and complete data will be the standard preceding approvals.

FDA’s “Gold Standard” Critical for Biopharma R&D

Beyond technology, awareness, and access—cultural competence is key.

Diversity in Clinical Trials: Path to Achieving Health Equity

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing. 

EMA Looks to Its Image

Rasmus Hogreffe, former Head of Virtual Trials at LEO Innovation Lab, and Morten Kirkegaard, Head of Clinical Operations and Co-founder at REDO-neurosystems, discuss their experiences with decentralized trials.

Decentralized Trials: Opening New Opportunities in Clinical Research

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

Debate Accelerates Over Who Gets COVID Vaccine First

The search for a coronavirus vaccine is just one of many questions unanswered on European health policy.

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