Tag:

NICE

Latest Headlines

Latest Headlines

U-turn from U.K.'s NICE boosts Biogen's high-flying Tecfidera

Biogen Idec's multiple sclerosis pill Tecfidera has been steamrolling since it hit the U.S. market last April. And now, it's poised to pad global sales with a victory in the U.K., whose cost watchdog has given it the OK in final guidance after flip-flopping on a February decision not to endorse the drug.

NICE likes Lundbeck's alcohol-addiction drug Selincro

Lundbeck has gotten a recommendation from the U.K. cost watchdog for its alcohol-addiction drug Selincro. It is estimated that there are about 600,000 potential users in the U.K. A final decision is slated for fall.

Novartis pulls EMA app for new Tasigna use, but wins new NICE nod for Gleevec

As blood cancer wonder-drug Gleevec ages, Novartis is trying to build out indications for follow-up Tasigna. After an up-and-down week for the pair, the Swiss pharma is now short a potential Tasigna label expansion, thanks to a snag in Europe. But a change of heart for the U.K.'s cost watchdog on Gleevec may give the franchise a boost.

Can clot-fighters get a boost from the U.K.'s new enthusiasm?

The cost-effectiveness watchdogs in the U.K. really, really want people to take their clot-busting drugs. Days ago, the National Institute for Health and Care Excellence touted the benefits of anticoagulants for patients with atrial fibrillation, and now, they're considering new backing for Eli Lilly's Effient.

NICE backs thousands more scripts for clot-fighters Pradaxa, Xarelto, and Eliquis

While their makers fight lawsuits and regulators keep watch on safety questions, the U.K.'s cost-effectiveness gatekeepers figure the new generation of anticoagulants should be used more to fight stroke, not less.

U.K. gatekeepers nix hep C drug Sovaldi till Gilead ponies up more evidence

Should the British health service pay for the expensive-yet-effective hepatitis C treatment Sovaldi? The U.K.'s cost-effectiveness gatekeepers say they're not convinced.

U.K. price watchdog changes its tune on BMS melanoma blockbuster Yervoy

Three months after Britain's National Institute for Health and Care Excellence said it would not recommend Bristol-Myers Squibb's Yervoy as a first-line treatment for melanoma, the much-feared cost-effectiveness agency has changed its mind. A new draft guidance from NICE now says Yervoy should be available as the first choice for treating patients with advanced melanoma.

MS docs, activists pressure U.K. cost watchdog to bless Biogen, GW meds

The U.K.'s cost-effectiveness agency is accustomed to boos and hisses. The National Institute for Health and Care Excellence often turns down new treatments it considers too expensive for their payoff in patients. So, will a campaign by patient advocates sway its opinion on two new multiple sclerosis drugs?

Sanofi's new MS med scores a spot on U.K.'s NHS formulary

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.

eNeura receives 510(k) for second-generation migraine treatment device

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.