News

Biogen MS superstar Tecfidera misses estimates; hit with first confirmed PML case

Biogen Idec's new multiple sclerosis pill Tecfidera has been on a roll since its launch last year, with more than $1 billion in sales to its credit already. Today, however, the drug hit a couple of speed bumps: Third-quarter sales missed analyst estimates, and the company announced a patient had died after developing a rare brain infection previously linked to MS drugs.

GlaxoSmithKline sets $1.6B in new cost cuts, thanks in part to Advair's U.S. formulary discounts

The saga is familiar: An aging blockbuster loses steam to competing meds, and its maker gets out the cost-cutting ax to compensate.

Spinoff fervor grows: GSK looks at ViiV spinoff and investor tells Amgen to break things up

GlaxoSmithKline said today it is considering a spinoff of ViiV, the successful HIV-centric business it shares with Pfizer and Shionogi. Its talk of unlocking the "intrinsic" value of the business mirrored the language a hedge fund investor used hours earlier to suggest that Amgen do much the same thing, breaking into two companies, one for legacy drugs and one for new launches.

GSK dealmaking spawns management shake-up, putting Slaoui and Hussain in top slots

With a three-part, multibillion-dollar transaction with Novartis set to close next year, changes are on the way for GlaxoSmithKline--and, fittingly, for its top management ranks, too.

Roche plots $3.2B overhaul at Basel HQ, joining parade of Big Pharma building projects

Following the lead of other Big Pharma heavyweights, Roche is giving its corporate headquarters a facelift. The drugmaker will funnel 3 billion Swiss francs into a renovation project to upgrade its existing facilities and to add new buildings to its Basel, Switzerland-based site.

UPDATED: Vertex's Kalydeco scores FDA panel rec in R117H. Are bigger nods next?

Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.

Novartis hopes to rev up Theraflu relaunch with TV celeb Nick Cannon

Novartis has the face to launch a Theraflu comeback: entertainer Nick Cannon, who's advising Americans to get ready for flu season by getting vaccinated and stocking up on the over-the-counter remedy.

Can't stop gambling or shopping? Parkinson's meds may be to blame, JAMA study finds

When Parkinson's disease patients start taking new meds, doctors go on the lookout for the usual side effects: dizziness, nausea, and the like. But according to a new study, they need to think weird, too. The risk of compulsive behavior--gambling, shopping, sex--is much higher than previously thought.

Actavis, Sanofi, Boehringer jockey bids for OTC specialist Omega Pharma

Actavis seems to have a finger in every pie lately when it comes to pharma M&A, and rumor has it Omega Pharma's sales process is no exception.

Top investor bails on Valeant bid, backing Allergan-Shire combo instead

Valeant's takeover partner, Bill Ackman, is not slowing down in his pursuit to land a deal for Allergan. But a key investor may no longer be quite so gung-ho.

AbbVie faces stumbling blocks after cutting cord on $55B Shire deal

Days after AbbVie recommended that shareholders vote against its proposed $55 billion deal for Shire, the company officially cut the cord and terminated its pending merger. And while Shire has big plans to succeed solo, AbbVie could face a few stumbling blocks without the Dublin-based company by its side.

It's back to basics in M&A, and that's a good thing, Actelion CEO says

At least one potential tax-inversion buyout target is pretty happy about the new deal-quashing rules: Actelion CEO Jean-Paul Clozel. In fact, he says, the slap at inversions is not just good for him and Actelion, but for the whole pharma industry.

Will Pfizer rebid for AstraZeneca? Keep an eye on U.S. midterm election for clues

Will Pfizer come back at AstraZeneca? That's been the question of the summer, especially since the U.S. Treasury Department rolled out new rules for tax-inversion deals.

Regeneron's Eylea bests Lucentis, Avastin in diabetic eye disease, NIH study finds

Regeneron and Bayer's Eylea has been racking up sales that have consistently topped analyst expectations since its U.S. rollout in late 2011. Now, new data may help it potentially top them in a market Novartis and Roche got to first.

PhRMA hits back at payers with new site highlighting coverage shortfalls

U.S. payers have generated a lot of ink protesting against high drug prices. After all, headlines about expensive meds--and patients who can't get them--are catnip for readers.

Shire CFO jumps ship as post-AbbVie deal talk heats up

Shire is casting off on its own after AbbVie pulled the plug on its $55 billion proposed deal. But the Dublin-based company is losing more than just a merger, as one of its top dogs is jumping ship and joining a U.K. water firm.

Addiction-riddled Kentucky out for blood in $1B suit against OxyContin-maker Purdue

To settle or not to settle? That's always the question in drugmaker lawsuits, but Purdue Pharma faces a more dramatic choice than most in a Kentucky lawsuit. As Bloomberg reports, the state accuses the OxyContin maker of Medicaid fraud, false advertising, and 10 other claims--but the addiction epidemic is the crux of the matter.

UPDATED: Thumbing its nose at critics, Valeant touts Q3 growth, hikes forecasts

Valeant may have upped its Q3 revenue by 33% and beat analysts' bottom-line expectations--not to mention hiked its forecast for this year and next. But takeover target Allergan still isn't impressed. On the other hand, shareholders might be if Valeant hikes its hostile bid again, as its CEO now suggests.

Kalydeco in R117H patients? As AdComm nears, Vertex drug faces doubts

Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.

Bristol-Myers catches a break as Indian agency delays Sprycel patent decision

Prime Minister Narendra Modi got an ear full from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.