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Details:
Tyenne (tocilizumab biosimilar) is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.
Lead Product(s): Tocilizumab
Therapeutic Area: Immunology Product Name: Tyenne
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Lead Product(s): Ganirelix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Antagonä-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Details:
Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Lead Product(s): Diazepam
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
Details:
Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.
Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Lacosamide-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
Idacio® (adalimumab), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Product Name: Idacio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2022
Details:
Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Lead Product(s): Pralatrexate
Therapeutic Area: Oncology Product Name: Pralatrexate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
U.S.FDA has approved its biosimilar, Stimufend® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Stimufend
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
Stimufend (pegfilgrastim) is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).
Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Stimufend
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
Microscopic and elemental analyses determined the presence of particulates in Maxivial (sodium acetate) injection that is composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Lead Product(s): Sodium Acetate
Therapeutic Area: Nephrology Product Name: Maxivial
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022