Sanofi felt the sting of lost sales potential when the FDA nixed its multiple sclerosis treatment Lemtrada in December. But the EU sees things a bit differently, and now a new nod from Britain's cost watchdog has unlocked some new top-line potential.
Following the FDA's de novo approval of eNeura's device for the treatment of pain from migraine headaches with aura, the company announced May 23 that its second-generation SpringTMS received 510(k) clearance.
First it was good news, then it was bad news, and now it's good news again for Astellas' prostate cancer treatment Xtandi (enzalutamide) and its recommendation from the U.K.'s National Institute for Health and Care Excellence. At least it appears that way.
Let the price negotiations begin, the top executive for the U.K. price watchdog suggested today after the agency nixed Roche's pioneering breast cancer drug Kadcyla as too expensive.
After intitially recommending Roche's targeted cancer drug Tarceva for use by Britain's National Health Service, the U.K.'s National Institute for Health and Care Excellence said in February it was reviewing the recommendation. Now, it looks likely to revert back to its original stance--a reversal of fortune the Swiss drugmaker is pleased with.
The U.K.'s cost watchdog is changing up the way it evaluates drugs. The National Institute for Health and Care Excellence (NICE) will be zooming out to look at the bigger picture when assessing therapies, which could result in more positive recommendations--something drugmakers have been dreaming of for years.
The U.K.'s National Institute for Health and Care Excellence has spurned Sanofi's colon cancer treatment Zaltrap once again. And this time, the decision is final. The cost-effectiveness agency dismissed the French company's appeal, despite the offer of a discount.
German pharma giant Bayer got back-to-back bad news on two of its newest drugs, from two different countries, no less.
The U.K.'s National Institute for Health and Care Excellence has come around on Johnson & Johnson's Velcade as a first-line treatment for the blood cancer multiple myeloma. It approved the drug for the new use today, four months after initially saying it was unconvinced the benefits of the drug outweighed its costs.
Celgene is working to expand its portfolio of drugs, but for now its growth is primarily driven by extending the uses of its megablockbuster Revlimid. As successful as the myeloma drug has been, the U.K.'s NICE is again questioning its cost vs. benefit for certain patients.