Find Approved Drugs for Infections and Infectious Diseases in Clinical Development in UNITED STATES

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            Lead Product(s): Remdesivir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Gilead Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement August 07, 2020

            Details:

            Under the terms of the agreement, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to manufacture and supply remdesivir for Gilead.

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            Lead Product(s): Peramivir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Rapivab

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: U.S. Government

            Deal Size: $7.0 million Upfront Cash: Undisclosed

            Deal Type: Agreement September 03, 2020

            Details:

            U.S. Department of Health and Human Services (HHS) has exercised its option to purchase an additional 10,000 doses of BioCryst’s approved antiviral influenza therapy, RAPIVAB® (peramivir injection).

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            Lead Product(s): Taurolidine,Citric Acid,Heparin Sodium

            Therapeutic Area: Infections and Infectious Diseases Product Name: Defencath

            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 August 31, 2020

            Details:

            U.S. FDA has accepted for filing the Company’s submitted New Drug Application (NDA) for Defencath™, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI).

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            Lead Product(s): Third-generation hepatitis B vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sci-B-Vac

            Highest Development Status: Approved Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2020

            Details:

            Abstracts will feature data from the Phase 3 program evaluating Sci-B-Vac®, the company’s tri-antigenic prophylactic hepatitis B vaccine, in a late-breaker oral presentation and a poster presentation at The Digital International Liver CongressTM 2020 (ILC).

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            Lead Product(s): Eravacycline

            Therapeutic Area: Infections and Infectious Diseases Product Name: Xerava

            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 August 28, 2020

            Details:

            Everest Medicines ompleted patient enrollment for its Phase 3 clinical trial of eravacycline (marketed as Xerava™ in the US and EU) for the treatment of complicated intra-abdominal infections (cIAI) in patients in China.

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            Lead Product(s): Remdesivir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury

            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 August 28, 2020

            Details:

            U.S. FDA expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury® (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.

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            Lead Product(s): Third-generation hepatitis B vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sci-B-Vac

            Highest Development Status: Approved Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 20, 2020

            Details:

            Company is going present two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac®, the company’s tri-antigenic prophylactic hepatitis B (HBV) vaccine, have been accepted for presentation at The Digital International Liver CongressTM 2020 (ILC).

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            Lead Product(s): Obiltoxaximab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Anthim

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 12, 2020

            Details:

            Health Canada has approved the company's New Drug Submission (NDS) for Anthim (obiltoxaximab for injection), the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax.

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            Lead Product(s): Emtricitabine,Tenofovir Disoproxil Fumarate

            Therapeutic Area: Infections and Infectious Diseases Product Name: Truvada

            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 August 11, 2020

            Details:

            China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF).

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            Lead Product(s): Remdesivir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Veklury

            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 August 10, 2020

            Details:

            Filing based on Phase 3 clinical studies of Veklury which demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement.

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