Good morning, everyone, the middle of the week has arrived and this calls for a celebratory cup or two of stimulation. How so? Well, you made it this far, which can be an accomplishment, after all. Moreover, there is always good reason to forge ahead, given that there is so much more to do and the effort just might pay off. With this in mind, we have fired up the trusty coffee kettle. Our choice today is crème brûlée. Meanwhile, we have assembled the usual menu of tidbits for your perusal. Hope you have a smashing day, and do drop us a line when you run across something interesting. …
In an otherwise unremarkable storefront in Omaha, Neb., a little-known clinic called XCancer has become one of the most trusted research partners of pharmaceutical companies seeking to test experimental prostate cancer medicines, Bloomberg News writes. XCancer and its sole physician, Luke Nordquist, have participated in more than 200 trials over 15 years. A big draw is speed: Nordquist says he can open a trial in as little as two weeks, unlike big academic research centers that take several months because of layers of management and lengthy internal review protocols. The clinic is emblematic of a larger shift. Increasingly, such privately owned clinics are the engine room of a fast-growing, lucrative and, for many patients, little-understood business. Drug trials offer people with cancer hope and free medicine, and open routes to new profits for pharma companies. But the flood of money — by one estimate, $80 billion a year is spent on oncology trials — is also creating incentives for doctors to sign up patients for unproven treatments and at times bending traditional research norms.
The U.S. Food and Drug Administration approved GSK’s add-on treatment for severe asthma, offering a less frequently dosed option, but rejected its use for another condition, Reuters notes. The decision comes as GSK’s commercial chief Luke Miels prepares to take over as chief executive officer early next year, with the drugmaker seeking new medicines to offset patent expirations. The FDA approved Exdensur as an add-on maintenance treatment for patients aged 12 and older with severe eosinophilic asthma, making it the first biologic cleared for twice-yearly dosing. But the FDA declined to approve the drug to treat chronic rhinosinusitis with nasal polyps, a chronic inflammatory sinus condition. On Monday, the U.K. health regulator approved the drug as an add-on treatment for asthma in patients aged 12 and older, as well as for chronic rhinosinusitis with nasal polyps in adults.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
Leave a Reply