AstraZeneca has completed the transfer of its global rights to Eklira (aclidinium bromide), known as Tudorza in the US, and Duaklir (aclidinium bromide/formoterol) to Covis Pharma Group (Covis Pharma).
AstraZeneca will sell global rights to chronic obstructive pulmonary disease inhalers Tudorza and Duaklir to Covis Pharma for $270 million, the British pharma said Monday. The company expects to close the deal soon, by year-end.
Three decades ago, a scientist at the University of Texas named Bruce Beutler asked the U.S. government to grant him a patent for a new invention.
Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced the launch of DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). DUAKLIR will be available in the United States on October 21st and promoted through its dedicated COPD sales force, alongside established COPD treatment TUDORZA® (aclidinium), which is also administered twice-daily via PRESSAIR®. The US launch of DUAKLIR will happen simultaneously with the American College of Chest Physicians’ CHEST Annual Meeting 2019 in New Orleans, LA.
Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced that the US Food and Drug Administration has approved DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).1
MORRISVILLE, N.C.--(BUSINESS WIRE)--Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), announced today that the US Food and Drug Administration (FDA) added new data to the TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.1 TUDORZA PRESSAIR is indicated for the maintenance treatment of patients with COPD.2
AstraZeneca says top-line results from a post-marketing study show that Tudorza Pressair is effective in reducing chronic obstructive pulmonary disease (COPD) exacerbations in patients with cardiovascular issues.
AstraZeneca has announced positive top-line results of the phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 µg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
A stream of breaches of the Association of the British Pharmaceutical Industry's Code of Practice has seen five pharmaceutical companies - AstraZeneca, Gruenenthal, Janssen-Cilag, Boehringer Ingelheim and Eli Lilly - named and shamed in the British medical press.
US FDA Enforcement report- 30/Mar/2016