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Search results for "EU ORPHAN DRUG|Positive" in comments (approximate match)
Status:
Designated
Source:
EU-Orphan Drug:EU/3/15/1536
Source URL:
Class:
PROTEIN
Status:
Designated
Source:
EU-Orphan Drug:EU/3/18/2040
Source URL:
Class:
PROTEIN
Status:
Designated
Source:
EU-Orphan Drug:EU/3/17/1951
Source URL:
Class:
PROTEIN
Status:
Designated
Source:
EU-Orphan Drug:EU/3/14/1423
Source URL:
Class:
PROTEIN
ImMucin is a 21-mer long peptide therapeutic vaccine encoding the entire signal peptide (SP) domain of the MUC1 tumor-associated antigen, which is over expressed by most hematological tumors including multiple myeloma (MM). Preclinical studies of ImMucin and its internal epitopes in multiple myeloma suggested superior immunological and anti-tumor properties compared to other MUC1 TRA‐derived epitopes. ImMucin demonstrated encouraging short and long-term safety profile. Vaccination induced a remarkable anti-MM immune response. However, immunity was transient suggesting a need for boosting. Interestingly, durable disease stabilization was achieved in the third of the patients, continuing despite the loss of immune response in peripheral blood. Moreover, the encouraging responses to subsequent therapies employed at clinical progression, suggest this novel approach to be potentially valuable in the setting of maintenance and/or early biochemical progression.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(8)(ii) digestive aid stem bromelain
Source URL:
First approved in 2021
Source:
21 CFR 333D
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
SURFAXIN
(2012)
Source URL:
First approved in 2012
Source:
SURFAXIN
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Sinapultide is a synthetic peptide used to mimic human lung surfactant protein B, the most important surfactant protein for a proper functioning of the respiratory system. Protein B lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in respiratory distress syndrome. Sinapultide compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants. Sinapultide was originally developed in the Scripps Research Institute and then licensed to Windtree Therapeutics (formerly Discovery Laboratories, Inc.). Sinapultide is the active ingredient of Lucinactant, a liquid medication to treat infant respiratory distress syndrome. Lucinactant was approved by the FDA in 2012 and sold under the trademark Surfaxin, but in 2015 it was discontinued by Discovery Laboratories, Inc in favor of Aerosurf, another drug containing Sinapultide.
Status:
US Previously Marketed
Source:
Xigris
(2001)
Source URL:
First approved in 2001
Source:
Xigris
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
BLA125795
(2023)
Source URL:
First approved in 2023
Source:
BLA125795
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
BLA125659
(2021)
Source URL:
First approved in 2021
Source:
BLA125659
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class:
PROTEIN