EMA says Bayer’s Diane-35 has more benefit that risk

Eric Palmer France drug regulator in January yanked Bayer's contraceptive Diane-35 off the market and insisted the European Medicines Agency investigate its off-label use as an ...

Victoza weight-loss nod could rescue Novo from Tresiba delay, CEO says

Tracy Staton Novo Nordisk and its profit-growth plans hit a roadblock earlier this year when the FDA refused to approve its new diabetes drug, Tresiba, without a new safety study. But ...

Don’t confuse Kadcyla with Herceptin, FDA says

Tracy Staton The FDA is picky about drug names. It's been known to reject brand monikers because they're too similar to others already out there in the market, worried that ...

Amgen blood drugs may help humans survive nuclear attack, FDA says

Tracy Staton Here's a story that takes us back to our Cold War childhood. Two of Amgen's ($ AMGN) blockbuster blood drugs, Neulasta and Neupogen, may help victims survive ...

Drugmakers, get ready for bigger, faster dealmaking, Moody’s says

Tracy Staton Deal junkies, rejoice. Moody's Investors Service figures pharma M&A will pick up in 2013, after a not-so-exciting 2012. But even if the pace picks up, deal size ...

Merck kept mum on Fosamax’s fracture risks, trial lawyer says

Tracy Staton Image courtesy of NIH Did Merck know about increased fracture risk in Fosamax patients years before the osteoporosis treatment hit the market? A plaintiff’s ...

Vivus investor says FDA move on Qsymia isn’t enough

Tracy Staton At least one Vivus ($ VVUS) shareholder isn't convinced that loosening FDA restrictions on a new obesity pill will fuel sales in any significant way. First Manhattan, ...

Roche CEO says no need to buy out Japanese subsidiary Chugai

Eric Palmer When it comes to its investment in Japan's Chugai Pharmaceutical, Roche CEO Severin Schwan says he likes things just the way they are. "We don't see changes ...
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