Clinical Trials

COVID-19: Scientific innovation will help us beat this virus

“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” Marie Curie The Coronavirus (COVID-19) pandemic has taken the world by storm with over 380K+ cases confirmed worldwide and 16K+ deaths as of this writing.1 Although the word “pandemic” […]

Regulatory reform in China enhancing clinical trials review and approval

In order to encourage innovation, speed up access to new drugs and meet the needs of patients, an updated investigational new drug (IND) review procedure was created in China and has been in effect for just over a year. The change drew discussion at both the DIA China 2019 meeting in Beijing in May as […]

Immuno-oncology spotlight on diverse therapeutic classes

Immune checkpoint inhibitors, such as the multi-billion-dollar drugs Keytruda and Opdivo, have dominated the immuno-oncology landscape in recent years (see Figure 1), but are not the only classes on the market or in development. T-cell engager therapeutics, oncolytic virus therapy and adoptive T-cell therapies were among the promising technologies covered at the fourth annual Immuno-Oncology […]

Fatty liver disease, NASH surge amid global obesity epidemic

Non-alcoholic fatty liver disease and the more severe form of this disease called non-alcoholic steatohepatitis, or NASH, are two increasingly prevalent diseases characterized by the progressive accumulation of fat or triglycerides within the liver. This accumulation occurs in the absence of excessive alcohol consumption. It can lead to inflammation, oxidative damage and the development of […]

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FDA draft guidance addresses inclusion of adolescents in oncology trials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investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials.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 […]

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 […]

Green light to market Hemlibra for hemophilia A with inhibitors in the US

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.   Roche Holding’s Hemlibra (emicizumab-kxvh) has been approved in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding […]

NGS, maybe, sort of, sometimes clinic ready

Detailed genomic profiling is a sine qua non of precision medicine, and at tertiary cancer centers, the comprehensive profiling of tumors and matched germline DNA is becoming ever more routine.