Europe

Scotland's NICE dislikes GSK's Anoro

The Scottish Medicines Consortium gave a thumb's down to GSK's drug and a Boehringer COPD drug.

EU mulls new Prevnar 13 indication

A greenlight could garner Pfizer $1B in sales.

Britain's NICE sidelines Kadcyla

Britain's NICE sidelines Kadcyla

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Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

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Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

Biogen CEO cautions on Tecfidera EU launch

Biogen CEO cautions on Tecfidera EU launch

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The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.

Business briefs: Sanofi, GlaxoSmithKline, AllTrials

Sanofi named in China corruption probe; GlaxoSmithKline starts a venture capital fund; and European non-profit AllTrials outlines its transparency goals

Business briefs: GSK, Otsuka, Roche and Gilead

GSK seeks a new ovarian cancer indication for Votrient; a bill that would extend exclusivity for some combination drugs is introduced in Congress; Otsuka's tolvaptan gets a thumbs-down from an FDA advisory committee; NICE rejects Roche's Perjeta; India tosses Herceptin patents; and China revokes Gilead's patent on Viread

Regeneron seeks to edge Roche out of DME space

Regeneron seeks to edge Roche out of DME space

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Regeneron says it will seek a diabetes macular edema indication for Eylea this year, potentially encroaching on yet another Lucentis market.

The complexity of cracking open the data door

The complexity of cracking open the data door

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Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.

EU backs Remicade biosimilars; anti-TNFs at risk

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CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.

Breakup, Xeljanz plans dominate Pfizer earnings call

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Sales slipped 9% during the quarter, compared to the same period last year, but analysts zeroed in on if and when the company will split and how arthritis pill Xeljanz will tackle Europe.

Why SGLT-2s may put some spring into pharma spending

Why SGLT-2s may put some spring into pharma spending

Should the FDA give the thumbs-up to J&J diabetes pill Invokana tomorrow, expect a blockbuster US marketing push, says CSD's Jerry Maynor.

European regulators to publish clinical trials data

European regulators to publish clinical trials data

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The head of the European Medicines Agency has said it's a matter of how, not if, the body will mandate publication of clinical trials data—and that has pharmas on both sides of the Atlantic sweating the potential implications for global competitiveness.

Boehringer: Pradaxa, Tradjenta launches face 'economic headwind'

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The family-owned pharma cautioned that early 2012 success doesn't mean the second half will be a breeze.

UK's drug promotion umpire issues internet guidance

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The UK's Prescription Medicines Code of Practice Authority (PMCPA), which arbitrates drug industry self-regulation there, last week issued "informal guidance" on digital communications, and while it's more than FDA has offered, it's not much to go on.

PhRMA sweats Witty's EU samples cap

PhRMA sweats Witty's EU samples cap

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PhRMA said the reasoning behind a sharp cap on samples mandated by its European counterpart doesn't apply in the US.

Wyeth taps Jane Seymour for European RA campaign

Wyeth taps Jane Seymour for European RA campaign

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Wyeth enlisted actress and artist Jane Seymour for an unbranded rheumatoid arthritis campaign in Europe.


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