Good afternoon, readers.
All aboard the fish train! On Wednesday, shares of biotech Amarin shot up more than 11% after the company got another piece of good news in what’s been (so far) a fortuitous 2019 – a Food and Drug Administration (FDA) priority review for its prescription strength fish oil pill Vascepa.
Amarin’s stock is now up a relatively modest 6% on the year after a bit of a tug-of-war between bulls who love the company’s clinical trial results and the bears who are betting FDA reviewers will give that data a more critical eye. But it’s still up an eye-popping 440% over the past 12 months.
What’s so special about this particular fish oil pill (especially given that Omega-3 fish oils have been somewhat controversial as supplements in recent years)? For one, it’s different from the over-the-counter fish oil pill varieties; for another, the clinical results Vascepa has touted include a 25% reduction in the risk of devastating cardiovascular events like heart attack and stroke in certain high-cholesterol patients who are taking statins (but still have elevated triglycerides).
All eyes will now be on an FDA advisory panel’s review of Vascepa to be held later this year. With the priority review, the agency is expected to make a decision by the end of September.
Read on for the day’s news.
BioMarin sinks on lackluster hemophilia gene therapy data. Gene therapies have had a series of notable successes in recent years (including Novartis’ regulatory victory for Zolgensma). But things don’t always quite work out as planned in what’s still a relatively nascent space. Rare disease drug specialist BioMarin spooked investors after announcing lackluster data for its gene therapy to treat the blood disorder hemophilia A, largely over concerns that while the drug presents a benefit, that benefit may not be durable over a long term (and thus wouldn’t present a cure). Given the massive prices associated with such therapies, the promise of a one-off cure is what the market is hungry to see. (Barron’s)
An opioid overdose victim’s dad’s emotional testimony against Johnson & Johnson. Sometimes, things really do speak for themselves. “We had no idea about the prevalence of these drugs and the dangers of these drugs,” said one Oklahoma college student’s father during the state’s ongoing trial against Johnson & Johnson for alleged deceptive marketing of the painkillers. Craig Box’s son died of an opioid overdose in 2011 after being found unconscious at a friend’s house. (Reuters)
THE BIG PICTURE
It’s official – workplace burnout is a major health problem. Workplace burnout has now been dubbed a public health problem by none other than the World Health Organization (WHO). Technically, the WHO isn’t considering the issue a “medical condition;” it is, however, enough of a workplace phenomenon that it’s now included in the organization’s official handbooks. Burnout, according to the WHO, results from “chronic workplace stress that has not been successfully managed.” (CBS News)
The Splinternet Is Growing, by Jeff John Roberts
|Produced by Sy Mukherjee|