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.
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.
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 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.
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.
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.
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.
Johnson & Johnson taking its network of biopharma incubators to Texas in an expansion of its Janssen Labs initiative.
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.
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 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 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.
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.
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 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.
The saga is familiar: An aging blockbuster loses steam to competing meds, and its maker gets out the cost-cutting ax to compensate.
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.
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.
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.
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.