Drug Development

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]

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 […]

Diverse approaches in immuno-oncology

A fascinating range of insights into the ways in which the immune system can be harnessed to fight cancer was provided by Global Engage’s Immuno-Oncology Research & Technology Series meeting this month in London. The conference comprised five concurrent tracks covering cutting-edge developments in fields such as cell therapies, novel antibodies and neoantigens. Some of […]

Biopharma M&A engine fires up as new year rings in big deals

Bristol-Myers Squibb (BMS) Co.’s $74 billion bid for Celgene Corp. – which, if it closes, will become the largest M&A in biopharma history – “made for a fascinating opening” to the J.P. Morgan Healthcare Conference (JPM), said Jamie Munro, global practice leader, portfolio and licensing at Clarivate Analytics, especially given Celgene’s historic placemark as the […]

Neuroscience lures dealmakers despite drug development challenges

While no other therapeutic area matches oncology in dealmaking volume, neurology is “among the nearest contenders.” That’s the main theme of recent analysis developed by Jamie Munro and Helen Dowden, of Clarivate Analytics. Their article, “Trends in Neuroscience Dealmaking,” was featured in the Biopharma Dealmakers supplement to Nature Biotechnology and Nature Reviews: Drug Discovery. Munro, […]

Fast-forward: Larry Liberti on the evolving landscape of pharma regulation

  Larry Liberti has served as executive director of the Centre for Innovation in Regulatory Science (CIRS) since 2009. In that capacity, he has been actively involved in promoting best practices in the regulatory aspects of the development of medicines, especially in the emerging markets. He has worked in the fields of pharmaceutical regulatory affairs, […]

Alzheimer’s disease – the disease without cure or prevention

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis was gathered from Clarivate Analytics Cortellis.   The unmet need The new year has seen major setbacks […]

Modern tools to advance generic drug development and review

In news releases issued by the U.S. Food and Drug Administration (FDA), “firsts” always catch the eye. Because the majority of prescriptions in the U.S. are dispensed with generic medications, announcements of new “first generics” are especially noteworthy. These products are the first approval by the FDA that permits a manufacturer to market a generic […]