New drug nods for J&J, Lilly/BI, and Shire

Between FDA and European regulators, we've had three new drug approvals in 24 hours. That should give drug-launch aficionados plenty to contemplate over the weekend, even if they're trapped inside by hurricane-induced weather. Here's the list.

  • The European Commission gave the nod to Trajenta, the Boehringer Ingelheim and Eli Lilly diabetes remedy set to compete with other drugs in the DPP-4 inhibitor class: namely Merck's ($MRK) Januvia, AstraZeneca ($AZN) and Bristol-Myers Squibb's ($BMY) Onglyza and Novartis' ($NVS) Galvus. The drug is the first to come out of a diabetes partnership between Lilly and BI, launched with a $423.3 million upfront payment in January. BI-Lilly release | Report

  • Shire got the FDA nod for its Firazyr drug for hereditary angioedema, a rare genetic disease. And the company can sell it as a self-injected product to boot. This aspect is convenient, considering it's intended for acute attacks--and its competitors have to be administered by a doctor or by IV. Analysts said they're looking for $171 million in sales by 2016, up to $199 million by 2017. "They will get market share," Matrix analyst Navid Malik told Bloomberg. "This will give them really good, strong differentiation." FDA release | News | Report

  • Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals won FDA approval for its oral pain drug Nucynta ER. It's an extended-release version of the company's opioid drug Nucynta. Because it's an opioid, it's no surprise the approval came with a risk evaluation and mitigation strategy (REMS). Janssen release | Report

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