U.S. FDA Acting Commissioner Ned Sharpless emailed staff outlining the regulatory agency’s four main priorities.
EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.
The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.
The healthcare industry is ever evolving and today’s patients are far more engaged than the previous era of “doctor knows best.” Increasingly, not only are patients involved in managing their day-to-day health, they and their fellow patients, caregivers, and advocates are driving the progress of drug treatments from discovery to delivery as well.
Working in the rare disease space has never been more rewarding than it is today. Technology is turning what was once thought to be impossible into actual, tangible realities for physicians, patients, and families. There are many exciting advancements happening now – in real time – and even more on the horizon that demand our attention and advocacy to help bring them to light.
The first rule of rare: There are no rules. There are over 7,000 different rare diseases – each with its own symptomology, history, and clinical and political landscape. Most are virgin territory for marketers; only 5 percent have an approved treatment.
We are on the verge of a medical renaissance, a period of accelerated progress in the treatment and management of rare diseases. This reawakening also brings with it challenges that we must grapple with.
According to the National Organization for Rare Diseases 2019 Fact Sheet, more than 90 percent of the 7,000 known rare diseases do not have an FDA-approved treatment. It’s a privilege to bring brands to market for the patients, caregivers, families and physicians who so badly need them. In order to effectively launch into the rare disease space, there are elements to consider that take us well beyond standard launch prep. It’s these elements that will set one brand apart from another and contribute to a successful launch.
FCB Health Network held its annual Innovation Week from May 7-9, 2019. Here’s a topline summary for anyone who missed the event.
Healthcare consumers may love the idea of virtual care, but so far few are actually taking advantage of it. That’s the core message coming out of a recent Vivify Health survey, which showed 83 percent of consumers are interested in receiving virtual care, but only 17 percent have access to it.
