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Understanding disruptions to the antibiotic supply resulting from COVID-19

The COVID-19 pandemic has highlighted vulnerabilities within the generic drug supply chain. To minimize the effects of antibiotic API supply disruptions, it is important to understand the underlying reasons for shortages to then identify the best-fit manufacturing partners.   The COVID-19 pandemic has disrupted the global drug supply, as manufacturing companies contend with government-mandated or […]

Gaining insight with artificial intelligence

In part three of this blog series about best practices in toxicology, we continue the discussion from previous articles that outlined elements in the discovery stage that could impact safety, and considering a drug’s effects on toxicity of specific organs and specific patients via toxicogenomics, pharmacogenomics and pharmacoepigenomics. To help reach a deeper understanding of […]

Organ-specific Toxicity and Personalized Approaches

In part two of this blog series about best practices in toxicology, we continue the discussion from the previous post, which described the aspects of drug discovery that could impact safety. Because safety can vary by person and organ, we also need to identify how we can determine a drug’s potential toxic effects on specific […]

Identifying risks in drug discovery

It is estimated that for every eight active substances entering Phase I clinical trials, only one product is approved and marketed.[1] The low success rate for clinical trials is largely driven by poor efficacy in humans and adverse events leading to the discontinuation of a drug development program.[2] Findings related to the inherent properties of the […]

Celebrating 30 years of BioWorld

BioWorld™ has built an enduring relationship with everyone in the drug development and medical technology sectors. As we celebrate our 30th anniversary, we reflect on how the publication has changed over the years to accommodate shifts in media consumption and industry needs.   BioWorld has built an enduring relationship with everyone in the drug development […]

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 […]

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 […]