News

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

Who's afraid of a tax-inversion crackdown? Not Illinois-based Horizon Pharma, which plans to move its corporate address to Ireland today.

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 the new drug's price.

GSK China scandal resolved with $500M fine and suspended jail sentence

Chinese justice came swift and in secret for GlaxoSmithKline today. A top executive narrowly escaped prison, and the company was convicted and will pay a fine of nearly $500 million for bribery in a country known for its corruption.

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

Companies have been studying Stendra for some sort of competitive edge. Now, they may have found one: The FDA backed the ED pill as a fast-acting treatment, taken 15 minutes before sex. Previously, the directions prescribed a 30-minute lead time.

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

With the Ebola death toll mounting in West Africa, a Phase I trial of GlaxoSmithKline's experimental vaccine for the disease is underway at the U.S. National Institutes of Health.

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 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 trials.

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 latest slim-down move.

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 Tafinlar, which is among the new class of melanoma drugs that target tumor mutations. Not surprisingly, though, there's a catch: GSK must provide the drug at an undisclosed discount, according to NICE's guidance document announcing the decision.

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

An FDA advisory panel wants to limit the use of testosterone drugs for safety reasons--and the proposed restrictions would shrink sales significantly. That's not good news for AbbVie, the market leader, and other drugmakers that have been riding a surge of testosterone growth.

First-to-market launch? Bonus--but double bonus if you're Big Pharma

When it comes to launching a next-generation drug, first is always best, right? Press releases can call it a "first-in-class" product. Sales and marketing teams can get a leg or two up on any follow-up rivals. What's not to like? McKinsey & Co. wanted to find out.

Can AstraZeneca turn its Movantik constipation pill into a blockbuster?

AstraZeneca's brand-new Movantik has an edge on rivals in the opioid-induced constipation (OIC) market, which is expected to near $2 billion by 2017. It's the first mu-opioid approved for OIC, and the first mu-opioid pill, period.

Endo CEO touts 'exciting' $2.2B bid for Auxilium, but his target may not agree

Endo's got a deal for Auxilium Pharmaceuticals in mind. CEO Rajiv De Silva thinks it could be a home run, and analysts seem to agree. Auxilium, however, needs some time to think it over, and it's swallowed a poison pill to make sure it gets just that.

Regeneron nabs FDA 'breakthrough' tag for new Eylea use in diabetics

Plenty of drugmakers are chasing opportunity in diabetes. The fast-growing epidemic means new therapies are sorely needed. But dealing with diabetes directly isn't the only strategy. Regeneron figures it can score by treating some of the disease's long-term complications.

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

Analysts 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 for their obesity products, it could finally be on the way.

Sanofi and MannKind hatch plan to boost the margins on Afrezza

MannKind has been starved for cash, so it was huge for the California-based pharma to strike a deal with Big Pharma player Sanofi to help market its inhaled insulin Afrezza. But Sanofi has something else that can cut their costs and fatten up their bottom lines. It has insulin.

Pension fund sues AbbVie over expected high taxes from Shire deal

As if the merger-happy pharmaceutical industry didn't have enough to worry about, what with the federal government threatening to crack down on companies that flee overseas to lower their taxes, now there's another set of stakeholders protesting these so-called tax inversions: pension funds.

Roche says fake MabThera has surfaced in EU

Roche is again tracking down counterfeits of some of its cancer meds in Europe after an importer in Germany discovered the fakes. In this case, it is counterfeit MabThera, sold as Rituxan in the U.S.

New COO engineers a management shake-up at Takeda

Takeda didn't bring on non-Japanese COO Christophe Weber for nothing. The Osaka-based drugmaker, still faltering in the wake of its patent loss on diabetes champ Actos, was looking for a shake-up. And now, as promised, the blueprints for a new, reorganized company structure are here.

UPDATED: With FDA confab looming, Chantix experts can't persuade court to unseal Pfizer records

Next month, the FDA's expert advisers will take another look at Pfizer's stop-smoking drug Chantix. The official agenda: Weigh new data on Chantix's links to psychiatric side effects, and consider changing the black-box warning about those risks.

Allergan, Valeant agree on meeting date. Now, the fight for shareholder votes

After months of battling between Allergan and its pursuers, Valeant and Pershing Square Capital Management, the two sides have reached a truce--at least when it comes to an upcoming shareholder meeting.