Cortellis Clinical Trials Intelligence

Potential blockbusters make a splash on market entry

Potential blockbusters make a splash on market entry Earlier this year, the Cortellis Drugs to Watch 2019 report highlighted seven drugs predicted to launch in 2019 and achieve blockbuster status by 2023. By the mid-point of the year, Zolgensma has entered the market as the most expensive drug ever launched, Skyrizi has been approved and […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]

FDA draft guidance addresses inclusion of adolescents in oncology trials

With an eye toward helping industry, investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials. Allowing adolescents in relevant trials would allow for earlier access to life-saving drugs in this […]

FDA efficacy recommendations vary for hypogonadotropic hypogonadism drugs

New draft industry guidance from the U.S. Food and Drug Administration (FDA) underscores the importance of randomized, double-blind, placebo-controlled trials to establish the efficacy of drugs to treat male hypogonadotropic hypogonadism when it is caused by obesity or another acquired condition. The draft guidance also asserts the potential importance of patient-reported outcome (PRO) instruments to […]

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 […]

FDA guidance recommends diversity in clinical trials for medical devices, but can’t require it

The FDA often stresses the importance of enrolling diverse patient populations in clinical trials conducted to support product applications — both in industry guidance documents and during interactions with product sponsors. In Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies, guidance released in September 2017, the FDA makes multiple […]

Alzheimer’s disease: One year later

Alzheimer’s disease (AD) affects more than 35 million people worldwide and is the sixth-leading cause of death in the US, where its care costs are predicted to rise from $200 billion in 2012 to $1.1 trillion by 2050. The disease is the only one of the top-ten leading causes of death in the US that […]