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Aradigm Announces Receipt of Final FDA Minutes for the Type B Meeting on January 25, 2019
Posted on Thursday February 21, 2019
At the Type B meeting, Aradigm presented the results of the Third Party Evaluation (TPE) completed in December 2019 that addressed the clinical issue raised by the FDA in the complete response letter (CRL) received in January 2018. As previously announced, the TPE results confirm the primary and secondary pulmonary exacerbation (PE) endpoint analyses of the ORBIT-3 and ORBIT-4 trials as submitted in the NDA in July 2017. Based on the Orphan Drug Designation in bronchiectasis for Apulmiq, Aradigm asked the FDA to exercise its flexibility and allow a resubmission of the NDA.
Aradigm Announces Plans for Reorganization Under Chapter 11 of the U.S. Bankruptcy Code
Posted on Friday February 15, 2019
Aradigm Corporation (ARDM) (“Aradigm” or the “Company”) has filed for protection under Chapter 11 of the U.S. Bankruptcy Code in the Alameda County Court District to facilitate the sale of its assets. On February 11, 2019, Aradigm determined that without confirmation of funding from their primary investor and partner, the Company would not have enough funds to meet all of their future financial obligations. As a result, Aradigm’s Board of Directors issued a unanimous consent authorizing Aradigm Corporation to file for protection under Chapter 11 of the U.S. Bankruptcy Code.
Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA
Posted on Wednesday January 30, 2019
As part of the EMA regulatory review calendar for marketing authorization application submissions to the EMA for approval, Aradigm will expect a Day 180 List of Outstanding Issues in late March. The clock will stop again until Aradigm responds to those issues, usually within thirty to sixty days. One month later, Aradigm could expect an opinion by the Committee for Medicinal Products for Human Use (CHMP) to our request for approval or a presentation to the CHMP during a formal hearing, which will be followed by the CHMP opinion a month later.
Aradigm Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA)
Posted on Wednesday January 16, 2019
Aradigm Corporation (ARDM) ("Aradigm" or the "Company") today announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq. As previously reported, Aradigm received a Complete Response Letter (CRL) on 26 January 2018, from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Apulmiq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa). The CRL identified issues related to a manual re-review of patient-level pulmonary exacerbation (PE) data conducted by Aradigm after errors were discovered in the analyses performed by a contract research organization.