Bora CDMO Bora CDMO

X
[{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New NTM Treatment Guidelines Recommend Insmed's ARIKAYCE for Treatment of Patients with Refractory MAC Lung Disease","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Beyond Air","sponsor":"Cystic Fibrosis Foundation","pharmaFlowCategory":"D","amount":"$2.1 million","upfrontCash":"Undisclosed","newsHeadline":"CF Foundation Awards Up to $2.17 Million to Beyond Air\u00ae to Develop Portable NTM Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Valeo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Valeo Pharma Announces Amikacin Approval in CANADA and U.S. Launch of Ethacrynate Sodium","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Insmed","sponsor":"Taiba Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Taiba Middle East Announces a Commercialization and Distribution Agreement With Insmed for ARIKAYCE in the Countries of GCC","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Insmed Initiates Frontline Clinical Trial Program for ARIKAYCE\u00ae (amikacin liposome inhalation suspension) in Patients with MAC Lung Disease","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase IV"},{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Insmed's ARIKAYCE Approved by Japan's Ministry of Health, Labour and Welfare for the Treatment of Patients with NTM Lung Disease","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Insmed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Insmed to Showcase New Data Across Three Pillars at the American Thoracic Society 2022 International Conference","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]

Find Clinical Drug Pipeline Developments & Deals for Prestwick3_000395

Menu
Loading...
Filters Filter
×
FILTER:
filter Company
    filter Sponsor
      filter Country
        filter Therapeutic Area
          filter Study Phase

            Active Filter(s):

            Companies By Therapeutic Area

            Development Status

            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.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 28, 2022

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Taiba Healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 14, 2021

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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 therapy alone.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 23, 2021

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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.

            Lead Product(s): Nitric Oxide,Amikacin,Azithromycin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cystic Fibrosis Foundation

            Deal Size: $2.1 million Upfront Cash: Undisclosed

            Deal Type: Funding February 16, 2021

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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).

            Lead Product(s): Amikacin

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Arikayce

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 04, 2021

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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. market.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 12, 2020

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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 to MDR therapy alone.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 24, 2020

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity

            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 treatment options.

            Lead Product(s): Amikacin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Arikayce

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            ASK
            US
            PHARMACOMPASS
            Upload
            your Pipeline Activity
            Post Enquiry
            POST ENQUIRY