Cortellis

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]

Drug repurposing for rare disease treatment leads to reduced risk

Director of the Drug Discovery Platform of Parc Científic Barcelona, Jordi Quintana and his team secured funding to investigate a rare disease, amyloidosis. They set out to study a subset of the disease called familial amyloid polyneuropathy. Because of the rare nature of the disease and the limited patient base, traditional drug discovery and development […]

Applying regulatory flexibility in the age of COVID-19

A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency or pandemic. Although yet to be used extensively, these Emergency Use Pathways (EUPs) offer the regulatory flexibility needed to ensure that medical […]

The COVID-19 pandemic: European regulators respond

The COVID-19 pandemic is spreading around the world with, as of this writing, more than one million cases globally and more than 500,000 cases in Europe alone. Here we summarize how The European Medicines Agency (EMA) as well as the European Commission (EC), the Heads of Medicines Agency (HMA) and the European Center for Disease […]

Combating COVID-19: Insights from the BIO Europe conference

The Cortellis team regularly attends industry conferences to provide summaries, updates and insights on what’s happening across the life sciences R&D landscape. Here we summarize select proceedings from the spring BIO Europe Conference.*  In the wake of the coronavirus COVID-19 (SARS-CoV-2) pandemic and a lockdown on worldwide travel, the 14th Annual BIO-Europe Spring Partnering meeting […]

Do EMA and FDA review outcomes for new active substances (NASs) align?

In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities and goals. The Centre for Innovation in Regulatory Science (CIRS) and Sanofi partner on a study to evaluate their progress to date.   The common […]