BI/Pfizer’s Spiriva Shows Bronchodilator Effect, Not Dyspnea, Cmte. Says
Executive Summary
Boehringer Ingelheim/Pfizer's Spiriva demonstrates a clinically meaningful bronchodilator effect when used to treat chronic COPD patients, FDA's Pulmonary-Allergy Drugs Advisory Committee unanimously agreed Sept. 6
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From The Year-End Conference Calls....
Lilly GMP issues: Lilly will be "inspection-ready" at the Cymbalta dry products facility in the first quarter, with the Zyprexa IM parental facility FDA-ready "some time later," Exec Director-Investor Relations Simon Harford tells Jan. 23 conference call. "Whether they will have a date specified up-front or whether they will just arrive, which they have the right to do, is still yet to be determined." Although Lilly acknowledged that "significant dialogue" with FDA remains, "as time goes on, I think we feel a bit more positive about our situation on the manufacturing side," CFO Charles Golden says. "We've had no discussions whatsoever about a consent decree with them"...