Hello and happy Friday, readers! This is Sy.
Japanese officials granted an accelerated approval to the treatment, Xofluza from pharmaceutical maker Shionogi, last week. It could soon prove to be a significant competitor to Swiss drug giant Roche’s Tamiflu, one of the most common antivirals used to treat the flu. But it could also take until at least 2019 for Xofluza to reach the U.S. market.
Xofluza sets itself apart from Tamiflu in several key ways, according to Shionogi. For one, it requires far fewer doses—just a single pill, in fact, compared with the five-day, two-doses-per-day regimen required by Tamiflu. That could be significant given that infections tend to linger if you don’t follow through on the entire prescribed course of a medicine.
And then there’s the timeline. Xofluza was able to kill off the flu virus within 24 hours (compared with the nearly three days it takes Tamiflu to pull off the same feat) in trials. Admittedly, that rapid flu virus destruction doesn’t mean that your flu symptoms will subside just as fast; in fact, complete symptom elimination probably takes about the same time as Tamiflu does. However, symptoms begin to dissipate faster and aren’t necessarily as pronounced with Xofluza treatment, Shionogi says.
The company touts Xofluza’s unique action mechanism as the secret behind its success. Unlike other flu antivirals, Xofluza actually stops virus replication in its tracks by inhibiting an enzyme that the flu virus needs to multiply. That may sound like a major blow to Roche and Tamiflu; but the Swiss drug maker is actually allied with Shionogi, and will have the rights to commercialize the treatment in markets outside of Japan (including the U.S.) if and when it wins regulatory approval abroad.
Flu pandemics tend to put vaccines in the spotlight—especially this year, when the Centers for Disease Control (CDC) has found that the current flu vaccine is just 36% effective (and even less so against the nasty, most common strain going around, H3N2). But the development of more effective antivirals for people who have already been infected is a key element of fighting influenza, too.
Read on for the day’s news, and enjoy your weekend.
Reprogramming skin cells to treat MS. Scientists at the University of Cambridge may have discovered a novel way to treat multiple sclerosis, according to FierceBiotech—and it involves using patients’ skin stem cells. The process reportedly shows that these stem cells (in mice, at the very least) can be modified to become brain cells and then used to reduce the damage wrought by MS. (FierceBiotech)
Pharma and the war on regulation. PricewaterhouseCoopers is out with a wide-ranging new report assessing the effect the first year of the Trump administration has had on the FDA and drug development. Some key findings for companies in this space: “As the Trump administration continues to push for reduced rulemaking, the FDA could continue to rely on guidance documents, which outline nonbinding policy preferences and interpret existing regulatory authority. [FDA] Commissioner Gottlieb has started to use guidance documents to reform how generic drugs are overseen at the agency, and companies could see this approach extend to other areas as well. While the stakes may be lower for guidance than they are for regulation, companies should assess their capacity to offer comment on these documents to ensure changing FDA policy pronouncements don’t put them at a disadvantage. Companies should also identify administrative priorities and determine what impact they might have on their business.” (PwC)
THE BIG PICTURE
Obamacare could be propped up by… Scott Walker? Politics and policy can create some strange bedfellows—and abrupt opinion changes. Wisconsin Governor Scott Walker, a former GOP presidential candidate and diehard Obamacare opponent, is now pushing to strengthen his state’s Obamacare marketplaces, Politico reports. That includes a $200 million proposal to subsidize individual market health insurers for high-cost plan holders so that premiums don’t go up for everyone else in the Obamacare exchange. (Politico)
This Is the Price of Admission to Get Into the 1%, by Bloomberg
Tesla Is Sending Out Free Electric Vehicle Chargers, by Kirsten Korosec
Does the Video Game Violence Theory Actually Hold Up? by Chris Morris
|Produced by Sy Mukherjee|