CSBio CSBio

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and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CHINA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"Yisheng Biopharma"},{"orgOrder":0,"company":"Zenshine Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zenshine Pharmaceuticals' ZX-7101A Met the Primary Endpoint of the Phase 2 Study for the Treatment of Acute Uncomplicated Influenza in Adults","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Zenshine Pharmaceuticals"},{"orgOrder":0,"company":"Zenshine Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Dosed in a Phase 3 Clinical Study of ZX-7101A for the Treatment of Uncomplicated Influenza","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Zenshine Pharmaceuticals"},{"orgOrder":0,"company":"Gennova Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Drug Panel May Review Gennova's mrna Omicron Booster Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"INDIA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"Gennova Biopharmaceuticals"},{"orgOrder":0,"company":"Cantex Pharmaceuticals","sponsor":"Michigan Medicine","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2\/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Cantex Pharmaceuticals"},{"orgOrder":0,"company":"HilleVax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HilleVax Announces Completion of Enrollment of NEST-IN1 Phase 2b Clinical Study of HIL-214 Norovirus Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"HilleVax"},{"orgOrder":0,"company":"Memo Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Memo Therapeutics AG Receives FDA Fast Track Designation for AntiBKV as Treatment of BKV Infection in Renal Transplant Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Memo Therapeutics"},{"orgOrder":0,"company":"Biophytis","sponsor":"Intsel Chimos","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biophytis has Filed with the French National Authority for Health (HAS) an Application for Early Access Authorisation (EAA) for Sarconeos (BIO101) in the Treatment of Severe Forms of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biophytis"},{"orgOrder":0,"company":"Memo Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Memo Therapeutics AG Starts U.S. Pivotal Phase II\/III Clinical Trial with AntiBKV for Treatment of BKV Infection in Renal Transplant Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Memo Therapeutics"},{"orgOrder":0,"company":"Seqens","sponsor":"Biophytis","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Biophytis and SEQENS Sign a Partnership to Produce Sarconeos (BIO101) Active Compound","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Seqens"},{"orgOrder":0,"company":"Biophytis","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$3.8 million","upfrontCash":"Undisclosed","newsHeadline":"Biophytis Announces $3.8 Million Registered Direct Offering","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biophytis"},{"orgOrder":0,"company":"Biophytis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biophytis has Requested a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biophytis"},{"orgOrder":0,"company":"RedHill Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RedHill's RHB-107 Included in U.S. Government-Supported COVID-19 Platform Trial and Cleared for Initiation by FDA","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"RedHill Biopharma"},{"orgOrder":0,"company":"Laurent Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Laurent Pharmaceuticals Receives Health Canada\u2019s Approval to Initiate Phase 2\/3 Clinical Trial in Long COVID","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Laurent Pharmaceuticals"},{"orgOrder":0,"company":"Arcturus Therapeutics","sponsor":"CSL","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Arcturus Therapeutics and CSL Announce European Medicines Agency Validates Marketing Authorization Application for ARCT-154 Vaccine to Prevent COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"Arcturus Therapeutics"},{"orgOrder":0,"company":"Moderna Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Moderna Clinical Trial Data Confirm its Updated Covid-19 Vaccine Generates Strong Immune Response In Humans Against Ba.2.86","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"Moderna Therapeutics"},{"orgOrder":0,"company":"AN2 Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AN2 Therapeutics Commences Phase 3 Part of Phase 2\/3 Clinical Trial Evaluating Epetraborole for Treatment-Refractory Mycobacterium Avium Complex (MAC) Lung Disease","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AN2 Therapeutics"},{"orgOrder":0,"company":"HilleVax","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"HilleVax Announces Pricing of Public Offering of Common Stock","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Vaccine","graph2":"HilleVax"},{"orgOrder":0,"company":"Skyepharma","sponsor":"Biophytis","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Biophytis and Skyepharma Sign a Partnership Agreement for The Production of Sarconeos (BIO101)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Skyepharma"},{"orgOrder":0,"company":"Biophytis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biophytis Provides an Update on its Early Access Programs for Sarconeos (BIO101) in the Treatment of Severe Forms Of Covid-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biophytis"},{"orgOrder":0,"company":"Lumen Bioscience","sponsor":"U.S. Department of Defense","pharmaFlowCategory":"D","amount":"$16.2 million","upfrontCash":"Undisclosed","newsHeadline":"Lumen Bioscience Awarded $16.2 Million in DoD Funding to Advance LMN-201 through Late-Stage Trials","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Lumen Bioscience"},{"orgOrder":0,"company":"CytoDyn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"CytoDyn"}]

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            Details:

            Under the partnership, Skyepharma will develop finished product batches meeting the GMP standards of Sarconeos (20-hydroxyecdysone), an orally administered small molecule, for severe forms of Covid-19.

            Lead Product(s): 20-Hydroxyecdysone

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Biophytis

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership September 25, 2023

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            The agreement aims for the production of the active compound in Sarconeos (20-hydroxyecdysone), Biophytis' main drug candidate developed for three indications, severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy.

            Lead Product(s): 20-Hydroxyecdysone

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Biophytis

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 18, 2023

            Details:

            Acoziborole, a potentially transformative investigational treatment for sleeping sickness, has a favourable safety profile, with no significant drug-related safety signals reported.

            Lead Product(s): Acoziborole

            Therapeutic Area: Infections and Infectious Diseases Product Name: SCYX-7158

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: DNDi

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 30, 2022

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            With this agreement, the active pharmaceutical ingredient nirmatrelvir can be fully manufactured in Brazil by Nortec, ensuring safety and adherence to treatment for countries such as: South Africa, Tanzania, Venezuela, Bolivia, Ethiopia, Haiti, Honduras, among others.

            Lead Product(s): Nirmatrelvir,Ritonavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Nirmatrelvir-Generic

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: The Medicines Patent Pool

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement March 22, 2022

            Details:

            After obtaining the requisite clearance from the Central Drugs Laboratory, Dr. Reddy's Laboratories and RDIF have begun adaptive phase 2/3 clinical trials for the Sputnik V vaccine in India. The trial is a multicenter and randomised controlled safety and immunogenicity study.

            Lead Product(s): Gam-COVID-Vac

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sputnik V

            Highest Development Status: Phase II/ Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Russian Direct Investment Fund

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 01, 2020

            Details:

            The US based trial will begin at medical centers in New York and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo.

            Lead Product(s): Sarilumab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 16, 2020

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            PRO 140 (leronlimab) is a CCR5 antagonist with the potential for multiple therapeutic indications. It is being evaluated in phase 2 clinical trials for the treatment of HIV infection.

            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2024

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            The funding will be used to advance LMN-201, an investigational, orally delivered biologic drug to treat and prevent C. difficile infection, through late-stage trials.

            Lead Product(s): LMN-201

            Therapeutic Area: Infections and Infectious Diseases Product Name: LMN-201

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $16.2 million Upfront Cash: Undisclosed

            Deal Type: Funding October 17, 2023

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            HilleVax intends to use the net proceeds from the offering to fund the clinical development of HIL-214, a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis caused by norovirus infection.

            Lead Product(s): HIL-214

            Therapeutic Area: Infections and Infectious Diseases Product Name: HIL-214

            Highest Development Status: Phase II/ Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 19, 2023

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            Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models. It is being developed for treating severe forms of COVID-19.

            Lead Product(s): 20-Hydroxyecdysone

            Therapeutic Area: Infections and Infectious Diseases Product Name: Sarconeos

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 19, 2023

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