Clinical Trials

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

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 […]

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, […]

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FDA draft guidance addresses inclusion of adolescents in oncology trials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investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials.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

The contribution of Type 2 diabetes to the disease burden in South Africa

In South Africa, 1,826,100 cases of diabetes were reported in 2017, corresponding to a prevalence of 5.4%. Overall, numbers are reported to be increasing over time. Diabetes also ranked high among the top 10 leading natural causes of death, accounting for 5.4% of deaths (year 2015). Approximately 14% of ischemic heart disease, 10% of stroke, […]

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 […]

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.