Aradigm Corporation
3929 Point Eden Way
Hayward
California
94545
United States
Tel: 510-265-9000
Fax: 510-265-0277
Website: http://www.aradigm.com/
213 articles about Aradigm Corporation
-
Aradigm Announces Sale of Assets to Grifols, S.A.
4/3/2020
Aradigm Corporation announced on March 30, 2020, the Bankruptcy Court entered an order approving the sale by Aradigm Corporation to Grifols, S.A. of the Company's assets and intellectual property that pertain to Lipoquin, Free Ciprofloxacin, Apulmiq and any derivatives thereof.
-
Aradigm Announces Entering into an Asset Purchase Agreement with Grifols, S.A.
2/21/2020
Feb. 21, 2020 13:00 UTC NEWARK, Calif.--( BUSINESS WIRE )-- Aradigm Corporation (OTC PINK: ARDM) (“Aradigm” or the “Company”) today announced that the Company has entered into an Asset Purchase Agreement pursuant to which Grifols, S.A. (the “Buyer”) will acquire the Company’s assets and intellectual property that pertain to Lipoquin, Free Ciprofloxacin, Apulmiq and any derivatives thereof. The sale is subject to the approval of the Bankruptcy Court, and is subject to the results o
-
Aradigm Announces Withdrawal of European Marketing Authorization Application (MAA) for Linhaliq
10/30/2019
Aradigm Corporation announced that following a recent Oral Explanation, it has withdrawn its Marketing Authorization Application (MAA) for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).
-
Aradigm Receives Feedback Following an Oral Explanation With the European Medicines Agency
10/21/2019
Aradigm Corporation announced that following a recent Oral Explanation, it has received feedback that a negative opinion is likely to be received in November 2019 from the CHMP, a committee of the European Medicines Agency, for the centralized marketing authorization application for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa
-
Aradigm Announces Receipt of Final FDA Minutes for the Type B Meeting on January 25, 2019
2/22/2019
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.
-
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 Announces Plans for Reorganization Under Chapter 11 of the U.S. Bankruptcy Code
2/16/2019
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 Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA
1/30/2019
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 Announces Detailed Third Party Evaluation Results for Apulmiq (FDA)/Linhaliq (EMA)
1/16/2019
Aradigm Corporation announced specific, detailed results of an independent third party evaluation (TPE) of the Phase 3 clinical trial results for Apulmiq.
-
Aradigm Announces Results of Third Party Verification for Apulmiq (formerly Linhaliq)
12/20/2018
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.
-
Aradigm Announces Third Quarter 2018 Financial Results
11/15/2018
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 Announces Second Quarter 2018 Financial Results
8/14/2018
Aradigm Corporation announced financial results for the second quarter and six months ended June 30, 2018.
-
Aradigm Announces the Appointment of Dr. Theresa Matkovits to the Board of Directors
7/6/2018
Dr. Matkovits is Chief Operating Officer of ContraVir Pharmaceuticals
-
Aradigm Announces First Quarter 2018 Financial Results
5/15/2018
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.
-
Aradigm Announces the EMA Has Completed Its Validation of the MAA Submission
4/5/2018
The completion of the MAA validation is commensurate with the start date of the review procedure on March 29, 2018.
-
Aradigm Announces Fourth Quarter 2017 and Full Year Financial Results
3/23/2018
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
3/9/2018
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).
-
FDA Formally Rejects Aradigm's Linhaliq, Requests a New Phase III Trial for Reconsideration
1/29/2018
the 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 Announces FDA Advisory Committee Meeting for Linhaliq
12/1/2017
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.