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UPDATED: Germany gives an initial 'no additional benefit' on Biogen Idec's Tecfidera

Biogen Idec's multiple sclerosis blockbuster Tecfidera for a second time has hit a roadblock in its effort to replicate in Europe the kind of runaway success it has had in the U.S. Germany's price watchdog IQWIG says it has found "no additional benefit" for the treatment compared to existing options, a preliminary decision that could deny it premium pricing there.

Can Boehringer carve out space in a crowded COPD market with new approval?

The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.

Vertex scores 250 new Kalydeco patients with EMA approval

Vertex' patient pool for cystic fibrosis drug Kalydeco is getting wider--250 patients wider, to be specific. The European Medicines Agency has green-lighted the drug--originally approved for CF patients with at least one copy of the G551D mutation--for 8 additional mutations, spelling new revenue potential for the orphan drugmaker.

Teva gets more than half of U.S. Copaxone patients converted to long-lasting version

One of the key strategies being pursued by Teva Pharmaceutical Industries to protect itself against generic competition to Copaxone is to switch patients over to its new longer-lasting version of the drug. And in the U.S., the drugmaker is just over halfway there.

FDA comes around on Boehringer, Lilly's diabetes med Jardiance

The FDA is changing its tune on Jardiance, a Boehringer Ingelheim diabetes med it hasn't been so keen on in the past. After rejecting the drug in the face of a manufacturing issue, the agency Friday gave it approval to treat Type 2 diabetes.

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