101 documents

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03:32 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
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22:05 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Duaklir Genuair meets in Phase III to treat COPD

In September, AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from the Phase III AMPLIFY trial in about 1,595 patients with chronic obstructive pulmonary disease (COPD) showing that Duaklir Genuair aclidinium bromide/formoterol (Brimica, KRP-AB1102F, LAS40464) met the...
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21:20 , Apr 28, 2017 |  BioCentury  |  Finance

A different animal?

For the second time, macro factors will make it hard to divine how much impact, if any, a clinical failure at Circassia Pharmaceuticals plc will have on investor sentiment in the U.K. But at least...
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20:34 , Apr 21, 2017 |  BC Week In Review  |  Clinical News

HDM-SPIRE: Ph IIb data

Top-line data from a double-blind, international Phase IIb trial in 714 house dust mite allergic patients with moderate or severe allergy symptoms showed that 12 and 20 nmol HDM-SPIRE every 4 weeks for 12 weeks...
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20:35 , Apr 18, 2017 |  BC Extra  |  Clinical News

Circassia abandoning allergy field after Phase IIb miss

Circassia Pharmaceuticals plc (LSE:CIR) said it will no longer develop allergy therapeutics following the failure of dust mite program HDM-SPIRE in a Phase IIb trial. The company plans to focus on its respiratory business, including...
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20:52 , Mar 23, 2017 |  BC Week In Review  |  Company News

AZ, Circassia deal

AstraZeneca agreed to share rights to two chronic obstructive pulmonary disease therapies with Circassia. Circassia will lead promotion of AZ's Tudorza Pressair aclidinium bromide in the U.S., and may opt to acquire full U.S. rights....
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22:25 , Mar 17, 2017 |  BC Extra  |  Company News

AZ, Circassia to share rights to two COPD therapies

AstraZeneca plc (LSE:AZN; NYSE:AZN) agreed to share rights to two chronic obstructive pulmonary disease therapies with Circassia Pharmaceuticals plc (LSE:CIR). Circassia is to lead promotion of AZ's Tudorza Pressair aclidinium bromide in the U.S., and...
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08:00 , Feb 15, 2016 |  BC Week In Review  |  Company News

Almirall, Kyorin, AstraZeneca deal

AstraZeneca and Kyorin terminated part of a 2011 deal granting Kyorin rights to develop aclidinium bromide in Japan as monotherapy or in combination with formoterol fumarate. Rights to the combination product, KRP-AB1102F , will revert...
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08:00 , Feb 1, 2016 |  BC Week In Review  |  Company News

AstraZeneca sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment reexamining Bretaris/ Eklira Genuair aclidinium bromide from AstraZeneca that the drug had “considerable added benefit” to treat grade III chronic...
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07:00 , Jul 13, 2015 |  BC Week In Review  |  Company News

Kyorin sales and marketing update

Kyorin launched Eklira Genuair aclidinium bromide in Japan to treat chronic obstructive pulmonary disease (COPD). The recommended dosage is one inhalation twice per day. The Japanese National Health Insurance (NHI) list price for the long-acting...
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