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...
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...
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...
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...
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...
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...
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....
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...
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...
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...