The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.
Gilead Sciences is charting eye-popping sales for blockbuster Sovaldi and chalking up a key regulatory approval for its new hep C combo pill, Harvoni. But the company's third-quarter earnings fell short of analysts' estimates in light of a hefty Obamacare fee and lower-than-expected revenue for its top-selling hep C drug.
Anyone following the hepatitis C drug market knows that Express Scripts CMO Steve Miller has a strong point of view. He's been quite vocal about Gilead Sciences' pricing on Sovaldi, the first in a new generation of oral treatments. Now, he's turned to the Gilead follow-up to that drug, a combo med dubbed Harvoni that aims to take the place of older cocktails.
Pharma CEOs are doing a pretty good job at the helm--at least where the Harvard Business Review is concerned.
Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the need for painful injections that have plagued patients for years.
Gilead Sciences' hepatitis C drug Sovaldi may be worth the sticker price. But it's too expensive for the U.K.'s health system to bear. That's the assessment in some National Health Service documents obtained by the Health Service Journal.
European countries are known for wresting price cuts from drugmakers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes.
Gilead Sciences is plotting a new, 400,000-square-foot manufacturing site near its current plant in San Dimas, CA, local media reports.
When Europe's drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.
Gilead Sciences, already a trailblazer in hepatitis C treatment, is creeping up on its next milestone: approval for a combination therapy that promises to cure the majority of patients without the need for painful injections.