News

Pfizer turns back Mylan's patent challenge to Sutent

Pfizer execs can sigh with relief now that a federal court has backed the company's patents on kidney cancer drug Sutent. The med has become increasingly important to Pfizer as sales of off-patent drugs have faded, and so it was alarming to the U.S. drugmaker when generics maker Mylan challenged the patent in 2010 and filed to make its own copy.

Yervoy, Sprycel, Eliquis jumps help Bristol-Myers beat Q3 estimates

The patent cliff may still be taking a toll on Bristol-Myers Squibb, but the company's Q3 sales haul was enough to impress analysts thanks to star performances from a few key new products.

EMA favors AstraZeneca's ovarian cancer drug Lynparza that FDA committee dissed

An FDA committee of experts this summer voted overwhelmingly against approval of AstraZeneca's new ovarian cancer treatment. But reviewers for the EMA gave it a nod for use on patients with platinum-sensitive ovarian cancer and BRCA mutations, FierceBiotech reports.

Shire poised to succeed as solo act post-AbbVie with solid Q3 earnings

Shire is riding solo after AbbVie called it quits on its proposed $52 billion acquisition, but the company isn't shedding too many tears. The Dublin-based drugmaker announced third-quarter earnings that beat analysts' expectations, leaving the door open for success post-AbbVie.

What does Pfizer's $11B buyback mean for the chances of an AstraZeneca bid?

Pfizer's $11 billion share buyback, announced late Thursday, gave investors something to focus on, rather than fretting about whether the company would renew its pursuit of AstraZeneca once the required cooling off period lapses in November. But some of them immediately started worrying about whether the buyback meant it was less likely Pfizer would do a big deal.

Actavis primed for another deal, or two, or maybe three

Allergan, Salix and Omega are all reportedly in Actavis' dealmaking sights, but which will the drugmaker go after? With an active M&A track record and deal veteran Brent Saunders at the helm, some analysts think the company could lock down more than one--but it won't necessarily be easy.

U.K. watchdogs back Bayer's Xarelto for heart attack patients

Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome--an indication the FDA has denied it on three separate occasions. But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.

J&J Innovation taps Texas for its latest biotech startup incubator

Johnson & Johnson taking its network of biopharma incubators to Texas in an expansion of its Janssen Labs initiative.

Leaping Soliris sales send Alexion's bottom line soaring

Alexion has had a win-some, lose-some year, what with a pricing challenge in the U.K. and a series of recalls for its only marketed drug. But that drug, Soliris, just keeps on surging. Sales grew 39% for the third quarter, hitting $555 million, and profits amounted to $177 million of that.

Medicines Company sues lawyers for busting Angiomax patent filing deadline

The Angiomax patent saga has a new chapter. Medicines Co. has now sued its law firms, Ropes & Gray and Fish & Neave, saying lawyers busted deadline for a key patent filing, risking premature generic competition for its best-selling anticoagulant.

Eli Lilly continues downward spiral in Q3 as generics slam Cymbalta, Evista sales

Eli Lilly found itself standing at the bottom of a steep slope this year, beleaguered by slumping sales and patent losses for two of its bestselling drugs. The Indianapolis, IN-based company is continuing on its downward spiral, reporting a 16% dip in revenue due to exclusivity losses on anti-depressant Cymbalta and osteoporosis drug Evista.

Celgene's powerhouse Revlimid gets a little Q3 help from new friends Pomalyst, Otezla

Celgene's growth engine Revlimid came through again this quarter. The blood cancer drug's $1.3 billion in Q3 sales--a 19% increase--helped the company hit sales estimates and beat profit expectations. And if a new first-line indication wins FDA approval, expected soon, the drug could take another leap next year.

Cancer survivor's petition pleads with Roche for lower Kadcyla price

Drugmakers are accustomed to grappling with government payers and PBMs over prices. But a pricing fight directly with patients? That's not your everyday occurrence.

New tax rules won't spook Mylan out of Abbott generics buy

A few potential deals have already caved under the weight of new U.S. tax rules that discourage inversion deals. Not Mylan's. The Pittsburgh-based company is pushing ahead with a $5.3 billion plan to buy a piece of Abbott Laboratories' overseas generics business--with a few edits, of course.

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.