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  • POWDER;INTRAVENOUS - EQ 1.25GM BASE/VIAL
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  • POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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Details:

VT-X7 (vancomycin hydrochloride and tobramycin sulfate) for irrigation is a novel drug/device combination product which is delivers broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat periprosthetic joint infection (PJI).


Lead Product(s): Vancomycin Hydrochloride,Tobramycin Sulfate

Therapeutic Area: Infections and Infectious Diseases Product Name: VT-X7

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 05, 2023

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VE202 is a first-in-class, orally administered, investigational live biotherapeutic product (LBP) consortium consisting of 16 strains of bacteria, which is investigated for the treatment of ulcerative colitis.


Lead Product(s): VE202,Vancomycin Hydrochloride

Therapeutic Area: Gastroenterology Product Name: VE202

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Vedanta Biosciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2023

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The proceeds will support NDA submission and preparation for commercial launch of company's VT-X7, a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin hydrochloride and tobramycin, for periprosthetic joint infection.


Lead Product(s): Vancomycin Hydrochloride,Tobramycin Sulfate

Therapeutic Area: Infections and Infectious Diseases Product Name: VT-X7

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Asteroid Partners

Deal Size: $23.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing September 21, 2023

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SER-155 composition aims to decrease the colonization and abundance of bacterial pathogens, and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections.


Lead Product(s): SER-155,Vancomycin Hydrochloride

Therapeutic Area: Immunology Product Name: SER-155

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 08, 2023

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VT-X7 (vancomycin hydrochloride and tobramycin sulfate) for irrigation is a novel drug/device combination product which is delivers broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat periprosthetic joint infection (PJI).


Lead Product(s): Vancomycin Hydrochloride,Tobramycin Sulfate

Therapeutic Area: Musculoskeletal Product Name: VT-X7

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2023

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VT-X7, (Vancomycin Hydrochloride), a drug/device combination product that locally delivers, via irrigation, highly targeted antibiotic therapy to the hip or knee during an accelerated seven-day interstage period of a two-stage exchange arthroplasty.


Lead Product(s): Vancomycin Hydrochloride,Tobramycin

Therapeutic Area: Musculoskeletal Product Name: VT-X7

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 04, 2022

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SER-155, an oral consortium of cultivated bacteria, is a microbiome therapeutic candidate in clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models.


Lead Product(s): SER-155,Vancomycin Hydrochloride

Therapeutic Area: Immunology Product Name: SER-155

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2022

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The proceeds will enable Osteal to continue development of its integrated technologies, advance the clinical development of its lead candidate, VT-X7 for treatment of periprosthetic joint infection and fund new research programs.


Lead Product(s): Vancomycin Hydrochloride,Tobramycin

Therapeutic Area: Infections and Infectious Diseases Product Name: VT-X7

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: HM Capital

Deal Size: $30.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing March 08, 2022

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The study results demonstrated that SER-287 administration was associated with positive impacts on clinical remission, endoscopic improvement, modulation of the gastrointestinal microbiome, and a favorable tolerability profile.


Lead Product(s): SER-287,Vancomycin Hydrochloride

Therapeutic Area: Gastroenterology Product Name: SER-287

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2021

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The Company announced that the Phase 3 trial of AeroVanc (vancomycin hydrochloride inhalation powder) in people living with cystic fibrosis (CF) who have Methicillin-resistant Staphylococcus aureus (MRSA) lung infection did not meet the primary endpoint.


Lead Product(s): Vancomycin Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Product Name: AeroVanc

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 10, 2020

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Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.


Lead Product(s): Vancomycin Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Product Name: Vanco Ready

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 02, 2020

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Sonoran's lead product SBG003 (tobramycin and vancomycin hydrogel) has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food & Drug Administration (FDA) for prevention of post-abdominal surgical site infection.


Lead Product(s): Tobramycin,Vancomycin Hydrochloride

Therapeutic Area: Infections and Infectious Diseases Product Name: SBG003

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 03, 2020

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Edge Pharma has signed an agreement with ANI Pharmaceuticals to market the company's FDA approved Vancomycin Hydrochloride for Oral Solution USP, a generic equivalent to Vancocin®.


Lead Product(s): Vancomycin Hydrochloride

Therapeutic Area: Gastroenterology Product Name: Vancomycin Hydrochloride-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: ANI Pharmaceuticals Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 25, 2020

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