Publication: FiercePharma

First reported 1 hour ago - Updated 1 hour ago - 1 reports

UPDATED: Europe approves Gilead's cancer drug Zydelig amid challenging pricing environment

The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on ... [Published FiercePharma - 1 hour ago]
First reported 21 hours ago - Updated 7 hours ago - 1 reports

Inversion pushback won't scare Horizon Pharma out of Ireland move

Who's afraid of a tax-inversion crackdown? Not Illinois-based Horizon Pharma ($HZNP), which plans to move its corporate address to Ireland today.If legislation submitted recently by congressional Democrats becomes law, Horizon will be forced to remain ... [Published FiercePharma - 21 hours ago]
First reported 21 hours ago - Updated 18 hours ago - 1 reports

President and advisory panel zero in on combating antibiotic resistance

President Barack ObamaPresident Obama is cracking down on so-called superbugs, those that cause deadly antibiotic-resistant infections, with an executive order that will establish a task force to combat the problem. The move coincides with a new report ... [Published FiercePharma - 21 hours ago]
First reported 21 hours ago - Updated 21 hours ago - 1 reports

Novo finds new way to sell Tresiba in EU while awaiting another shot in U.S.

Xultophy is a combo of Tresiba and VictozaShareToolsNovo Nordisk ($NVO) is hustling to get work done so that it can resubmit its blockbuster hopeful Tresiba to the FDA next year with an eye on getting into the market by 2016, three years after the FDA ... [Published FiercePharma - 21 hours ago]
First reported 21 hours ago - Updated 21 hours ago - 1 reports

Analysts: Bayer could use plastics proceeds to fund a deal for Zoetis

Now that Bayer has announced a planned spinoff of its plastics business, all eyes are on what it may do with the proceeds. And the way some analysts see it, that money could go toward a pickup of animal health company Zoetis ($ZTS).The German pharma's ... [Published FiercePharma - 21 hours ago]
First reported Sep 18 2014 - Updated 22 hours ago - 1 reports

FDA backs ED upstart Stendra as a fast-acting alternative to Viagra

It's no picnic competing with a cultural phenom. Auxilium ($AUXL) and Vivus ($VVUS) know this well: Their new erectile dysfunction pill Stendra has to go up against Pfizer's ($PFE) Viagra. Competition from Eli Lilly's ($LLY) blockbuster Cialis doesn't ... [Published FiercePharma - Sep 18 2014]
First reported Sep 18 2014 - Updated 22 hours ago - 1 reports

Real-world hep C patients drop off pricey Sovaldi, CVS study finds

CVS Health has some hard data on Sovaldi's excursion from the Gilead Sciences ($GILD) clinic and into the world. It's not encouraging: More than four times as many real-world patients are dropping off the pricey hepatitis C treatment than in clinical ... [Published FiercePharma - Sep 18 2014]
First reported Sep 18 2014 - Updated Sep 19 2014 - 1 reports

Glaxo Ebola vax shows no adverse effects so far in first human trial

NIAID Director Dr. Anthony FauciWith the Ebola death toll mounting in West Africa, a Phase I trial of GlaxoSmithKline's ( $GSK ) experimental vaccine for the disease is underway at the U.S. National Institutes of Health. And so far, health officials have ... [Published FiercePharma - Sep 18 2014]
First reported Sep 18 2014 - Updated Sep 18 2014 - 1 reports

Bayer brings $12.9B plastics spinoff to Big Pharma's slim-down party

Bayer's drug business is booming. So much so that the German company has decided to put its focus squarely on its life sciences division: It plans to spin off its plastics unit within 18 months, taking a lead from its Big Pharma peers with the industry's ... [Published FiercePharma - Sep 18 2014]
First reported Sep 18 2014 - Updated Sep 18 2014 - 1 reports

Put a lid on 'Low-T' drug use, FDA panel advises, threatening AbbVie, Lilly meds

The testosterone-drug party may be over. An FDA advisory panel wants to limit their use for safety reasons--and the proposed restrictions would shrink sales significantly. That's not good news for AbbVie ($ABBV), the market leader, and other drugmakers ... [Published FiercePharma - Sep 18 2014]
First reported Sep 18 2014 - Updated Sep 18 2014 - 1 reports

NICE says 'yes' to GSK's melanoma pill, but only with a price cut

Britain's drug price watchdog, the National Institute for Health and Care Excellence (NICE), has given the go-ahead to GlaxoSmithKline's ($GSK) Tafinlar, which is among the new class of melanoma drugs that target tumor mutations. Not surprisingly, though, ... [Published FiercePharma - Sep 18 2014]
First reported Sep 17 2014 - Updated Sep 18 2014 - 2 reports

Are obesity drugs nearing a breakout? Novo, Takeda think so

Novo Chief Science Officer Mads Krogsgaard ThomsenAnalysts have been waiting--and waiting--for drugmakers to realize the growth they've predicted for the obesity market. And with a couple of pharma companies preparing to pony up R&D and marketing resources ... [Published FiercePharma - Sep 17 2014]

Quotes

...analyst Kevin Kedra told Bloomberg. "It would give them a business that has stable cash flow, steady growth and a relatively predictable business in an area that they know pretty well."
"You've got a divided Congress," he said. "The legislation that's being proposed right now is simply campaigning for the midterm elections."
Physicians in the U K are applauding NICE's approval of Tafinlar. "Its approval underlines the importance of a new generation of cancer drugs targeted at specific molecular features of [tumors]--drugs which after years of painstaking development are now making their way to patients" said Paul Workman, interim chief executive of London's Institute of Cancer Research, in an interview with the BBC
...In one spread, an amorous-looking couple embraces in a parked car. "This time he was ready ... before they got home" the tagline winks

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UPDATED: Europe approves Gilead's cancer drug Z... [Published FiercePharma - 1 hour ago]
Novo finds new way to sell Tresiba in EU while ... [Published FiercePharma - 21 hours ago]
President and advisory panel zero in on combati... [Published FiercePharma - 21 hours ago]
Analysts: Bayer could use plastics proceeds to ... [Published FiercePharma - 21 hours ago]
Inversion pushback won't scare Horizon Pharma o... [Published FiercePharma - 21 hours ago]
Glaxo Ebola vax shows no adverse effects so far... [Published FiercePharma - Sep 18 2014]
NICE says 'yes' to GSK's melanoma pill, but onl... [Published FiercePharma - Sep 18 2014]
FDA backs ED upstart Stendra as a fast-acting a... [Published FiercePharma - Sep 18 2014]
Put a lid on 'Low-T' drug use, FDA panel advise... [Published FiercePharma - Sep 18 2014]
Real-world hep C patients drop off pricey Soval... [Published FiercePharma - Sep 18 2014]
Bayer brings $12.9B plastics spinoff to Big Pha... [Published FiercePharma - Sep 18 2014]
Sanofi, MannKind say cutting insulin costs will... [Published FiercePharma - Sep 17 2014]
Are obesity drugs nearing a breakout? Novo, Tak... [Published FiercePharma - Sep 17 2014]
Can AstraZeneca turn its Movantik constipation ... [Published FiercePharma - Sep 17 2014]
Regeneron nabs FDA 'breakthrough' tag for new E... [Published FiercePharma - Sep 17 2014]
Endo CEO touts 'exciting' $2.2B bid for Auxiliu... [Published FiercePharma - Sep 17 2014]
First-to-market launch? Bonus--but double bonus... [Published FiercePharma - Sep 17 2014]
Pension fund sues AbbVie over expected high tax... [Published FiercePharma - Sep 17 2014]
Armed with 900 reps, Takeda aims for the Contra... [Published FiercePharma - Sep 17 2014]
Sanofi and MannKind hatch plan to boost the mar... [Published FiercePharma - Sep 17 2014]
Amarantus scores a small victory in the advance... [Published FiercePharma - Sep 16 2014]
New COO engineers a management shake-up at Takeda [Published FiercePharma - Sep 16 2014]
Roche says fake MabThera has surfaced in EU [Published FiercePharma - Sep 16 2014]
NY sues Actavis and Forest for 'monopoly' on Al... [Published FiercePharma - Sep 16 2014]
Switzerland wants to slash drug prices? Not so ... [Published FiercePharma - Sep 16 2014]
Allergan, Valeant agree on meeting date. Now, t... [Published FiercePharma - Sep 16 2014]
Cheaper alternative to licensed drug for treati... [Published FiercePharma - Sep 15 2014]
Pfizer, Ranbaxy prevail in antitrust fight over... [Published FiercePharma - Sep 15 2014]
Salix hands off Relistor, other drugs to Lupin ... [Published FiercePharma - Sep 15 2014]
Balky payers, beware: Gilead eyes $95K-or-so pr... [Published FiercePharma - Sep 15 2014]
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