102 documents

Read All
19:52 , Jan 17, 2019 |  BioCentury  |  Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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....
Read More
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...
Read More
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...
Read More
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...
Read More