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209 articles with Aradigm Corporation
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.
The season surrounding Valentine’s Day brings out the love in many people, but for two pharma companies, this year was a year of heartbreak. California-based Aradigm Corporation and New Jersey-based Immune Pharmaceuticals both filed Chapter 11.
Aradigm Corporation 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.
Aradigm Corporation (OTCQB: ARDM) (“Aradigm” or the “Company”) submitted responses to the European Medicines Agency (EMA) Day 120 questions on 23 January 2019. The due date for response to the questions was 25 January.
Aradigm Corporation announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.
The CRL stated that an independent third party would need to verify the results of the ORBIT-3 and ORBIT-4 Phase 3 trials before the FDA could draw any conclusions regarding the safety and efficacy of Apulmiq from these trials.
The Company recorded $282,000 in revenue in the third quarter of 2018 compared with $2.7 million in revenue in the third quarter of 2017.
Aradigm Corporation announced financial results for the second quarter and six months ended June 30, 2018.
Dr. Matkovits is Chief Operating Officer of ContraVir Pharmaceuticals
Company recorded $1.5 million in revenue in the first quarter of 2018 compared with $1.7 million in revenue in the first quarter of 2017.
The completion of the MAA validation is commensurate with the start date of the review procedure on March 29, 2018.
Cash and cash equivalents of $7.1 million expected to be sufficient to fund operations for Q1 2018; temporary measures implemented to preserve cash resources.
Aradigm Submits Marketing Authorisation Application (MAA) to EMA for EU Marketing Approval of Linhaliq in Non-Cystic Fibrosis Bronchiectasis
Aradigm Corporation announced it has submitted its Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Linhaliq™ for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa).
1/29/2018the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission.
From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year.
Aradigm Corporation announced that a meeting of the Antimicrobial Drugs Advisory Committee of the FDA has been scheduled for January 11, 2018 to review the Company’s New Drug Application (NDA) for Linhaliq.
Aradigm announced today that it will host a Key Opinion Leader (KOL) Breakfast on the topic of Non-Cystic Fibrosis Bronchiectasis (NCFBE) on Thursday, November 9, 2017 from 8:00-9:30 am Eastern Time in New York, NY.
The Company recorded $2.7 million in revenue in the third quarter of 2017 compared with $50,000 in revenue in the third quarter of 2016.