Specialty Pharma Journal Specialty, Precision & Technology
DARMSTADT, Germany, December 10, 2018 /PRNewswire/ — FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer First regulatory designation for M7824 following recent presentation of first clinical data in BTC BTC is a group of rare, aggressive gastrointestinal cancers associated with limited treatment options and …
Tag Archives: Orphan Drug Designation
December, 2018
November, 2018
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21 November
OBI Pharma’s Investigational Pancreatic Cancer Drug Granted Orphan Drug Designation by the FDA
TAIPEI, Taiwan, Nov. 21, 2018 /PRNewswire/ — OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-888 for the treatment of Pancreatic Cancer. OBI-888 is a first in class monoclonal antibody cancer immunotherapy targeting …
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20 November
FDA Grants Orphan Drug Designation to Pliant’s PLN-74809 for Treatment of Primary Sclerosing Cholangitis
SOUTH SAN FRANCISCO, Calif., Nov. 20, 2018 /PRNewswire/ — Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s anti-fibrotic lead compound, PLN-74809, for the treatment …
October, 2018
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24 October
FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin …
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16 October
FDA Grants Orphan Drug Designation to Lynparza for Treatment of Pancreatic Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated …
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11 October
FDA Grants Orphan Drug Designation to Synspira’s Investigational Cystic Fibrosis Therapy
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synspira, a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, today announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic …
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5 October
FDA Grants Orphan Drug Designation to MediciNova’s Investigational Glioblastoma Candidate
LA JOLLA, Calif., Oct. 04, 2018 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) as …
August, 2018
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16 August
Wave Life Sciences’ WVE-210201 Granted Orphan Drug and Rare Pediatric Disease Designations from the FDA for Treatment of DMD
CAMBRIDGE, Mass., Aug. 16, 2018 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both orphan drug designation and rare pediatric disease designation for …
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16 August
FDA Grants Orphan Drug Designation to Onspira’s Investigational Bronchiolitis Obliterans Therapy
WAYNE, Pa.–(BUSINESS WIRE)–Onspira Therapeutics, a privately-held clinical-stage biopharmaceutical company dedicated to developing therapies to treat rare, life threatening pulmonary diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101, for the treatment of Bronchiolitis Obliterans (BO). BO is a progressive …
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6 August
FDA Grants Orphan Drug Designation to Pliant’s Investigational Idiopathic Pulmonary Fibrosis Therapy
SOUTH SAN FRANCISCO, Calif., Aug. 6, 2018 /PRNewswire/ — Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company’s anti-fibrotic lead compound, PLN-74809, for the treatment …