Last year, the FDA approved dupilumab, the first biologic treatment for atopic dermatitis (AD), and a wave of similar products, now in clinical trials, followed. Biologics provide hope for those suffering from this chronic skin disease, also known as eczema, … Read More
Success of clinical trials is determined after the patient trials are over and the data has been analyzed. In order to eliminate bias and collect quality data which produces meaningful statistics toward study results, it is vital to conduct … Read More
Novella Clinical recently looked back at oncology milestones in 2017, now it’s time to switch gears and recount the biggest Medical Device & MedTech news. Regulatory Changes Streamline Medical Device Trials The US Food & Drug Administration (FDA) released a … Read More
As Novella Clinical says so long to 2017, we pause to look back at the year’s biggest oncology news and what it could signify for the year to come. CAR-T Crosses the Finish Line In August, the US Food and … Read More
Read the highlights of a lively Q&A discussion from a recent Novella Clinical webinar on considerations for biologic agents in the dermatology arena.
In that past two years, the FDA has approved 55 oncology drugs – including 33 in 2015, the most ever for a single year. These numbers resulted from the FDA’s growing practice of fast-tracking clinical trials for drugs that satisfy … Read More
Throughout his career in clinical and pharmaceutical oncology, Ben Manderman, MD, MPH, has demonstrated a passion for patient safety. He now brings more than 20 years of expertise, including 12 years of drug development with both pharmaceutical companies and global … Read More
An increasing number of products submitted to the US Food & Drug Administration (FDA) today combine a drug, a device, or a biologic. These combination products enhance or reveal new capabilities of its individual components. For instance, a stent that … Read More
The age of biologics in the treatment of dermatological indications is upon us. They hold promise for dermatological indications where treatments have been sparse. An increased demand for solutions to dermatological conditions where biologics might be effective can be attributed to several factors: increase in incidence of skin cancers, breakthroughs in biologics for psoriasis, and boomer generation demand for anti-aging products.
We’ve seen an increase in new oncology drug approvals over recent years because of promising advances in personalized medicine and immuno-oncology. From 2011 through 2016, there were 68 novel therapies launched globally for the treatment of cancer. Currently, there are … Read More