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Business News, In Brief

Executive Summary

Quintiles files IPO; Forest sees LAMA/LABA combo product, slated for a 2014 NDA, as filling out a suite of COPD drugs to cover the full range of disease severity. Plus news from a host of biopharma quarterly earnings calls.

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New COPD Candidates Could Get Hung Up On Safety Concerns

FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.

Newly Appointed Head of Regenerative Medicine At Shire Plans Rapid Growth For The Division

Jeff Jonas takes over Shire’s newly formed Regenerative Medicine business with plans for rapid growth, replacing Advanced BioHealing’s Kevin Rakin in the role.

GSK/Theravance Breathing Easy: Once-Daily COPD Combo Expected To Meet Regulatory Standards

With largely positive results from four of seven Phase III studies, GlaxoSmithKline and Theravance say they are on track for filing their LABA/LAMA combination UMEC/VI at the end of 2012. But some analysts are wary about regulatory prospects for any LABA-containing drugs and say concerns about dosing could trip up U.S. filing.

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