Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function.
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 28, 2022
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Taiba Healthcare
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the terms of the agreement, taiba will be responsible for the named patient supply program with intent to commercialize ARIKAYCE in the region following receipt of marketing authorization(s) in the territory.
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 14, 2021
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Taiba Healthcare
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The approval by the MHLW is based on results from the Phase 3 CONVERT study, which demonstrated that once-daily ARIKAYCE, with MDR, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared to MDR therap...
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 23, 2021
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Nitric Oxide,Amikacin,Azithromycin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Undisclosed
Sponsor : Cystic Fibrosis Foundation
Deal Size : $2.1 million
Deal Type : Funding
CF Foundation Awards Up to $2.17 Million to Beyond Air® to Develop Portable NTM Treatment
Details : The funding will support a clinical trial to determine whether high doses of inhaled nitric oxide are safe and effective when used in conjunction with current standard-of-care therapies, including amikacin and azithromycin.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 16, 2021
Lead Product(s) : Nitric Oxide,Amikacin,Azithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Sponsor : Cystic Fibrosis Foundation
Deal Size : $2.1 million
Deal Type : Funding
Lead Product(s) : Amikacin
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : First patient was dosed in late December, 2020, in the frontline clinical trial program of ARIKAYCE® (amikacin liposome inhalation suspension) in patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC).
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 04, 2021
Lead Product(s) : Amikacin
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Valeo Pharma Announces Amikacin Approval in CANADA and U.S. Launch of Ethacrynate Sodium
Details : Valeo Pharma has recently received a Notice of Compliance from Health Canada granting market authorization for Amikacin, an antibiotic used within the hospital setting. Valeo also announced that shipments of Ethacrynate Sodium have commenced in the U.S. ...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 12, 2020
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The CHMP opinion is based on results from the Ph 3 CONVERT study, which showed that once-daily ARIKAYCE, when combined with multi-drug regimen, improved sputum culture conversion rates in patients with refractory NTM lung disease caused by MAC compared t...
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 24, 2020
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The evidence-based guidelines recommend the use of ARIKAYCE for the treatment of refractory NTM lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treat...
Brand Name : Arikayce
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 07, 2020
Lead Product(s) : Amikacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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