API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
EU WC
Listed Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
The financing will advance the development of Osteal’s portfolio of therapies, including the submission of NDA and accelerated commercial launch of VT-X7 for treating PJI of the hip and knee.
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: Johnson & Johnson
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Series D Financing June 05, 2024
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
Details:
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
Details:
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
Details:
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
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: 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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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
Details:
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