AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations
Posted on30 Sep 2020
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AbbVie announced that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an... Read More
Evox partnership with Takeda Pharmaceutical for rare disease
Evox Therapeutics Ltd, a leading exosome therapeutics company, announced the signing of a rare disease-focused partnership with Takeda Pharmaceutical Company Limited. The... Read More
Recordati received exclusive rights to commercialize Juxtapid in Japan from Aegerion Pharmaceuticals
Posted on07 Feb 2019
TagsAegerion, HoFH, Juxtapid, Novelion Therapeutics, orphan drug, orphan drug designation, rare disease
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Recordati announces the signing of a license agreement with Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics Inc., for the exclusive rights... Read More
EMA grants orphan drug designation to PIQUR’s lead compound PQR309 to treat patients with DLBCL
What is orphan drug designation? The EMA orphan drug designation is a status assigned to a medicine intended for use against a... Read More
ARMO BioSciences’ Immunotherapy AM0010 Receives Orphan Designation in Europe
Posted on24 Dec 2016
TagsEuropean Medicine Agency, Orphan Designation in Europe, orphan drug, orphan drug act, orphan drug designation
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ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the European Commission (EC) has granted the Company’s lead investigational immuno-oncology drug AM0010... Read More
USFDA approved new drug Rubraca, rucaparib
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian... Read More
FDA grants accelerated approval to Eteplirsen, first drug for Duchenne muscular dystrophy
Posted on23 Sep 2016
TagsDuchenne muscular dystrophy, Eteplirsen, Fast Track designation, orphan drug, orphan drug designation, priority review
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The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular... Read More
Zymeworks’ ZW25, ZW33 received Orphan Drug designation for ovarian cancer
Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of... Read More
Case Study: AstraZeneca’s Crestor evergreening strategy: Orphan Drug’ Designation To Extend Patent Life
Crestor is the Top selling brand of AstraZeneca. Crestor sale was $5 billion of its $23.6 billion total product sales of Astra... Read More
Takeda and Tigenix’s Licensing Agreement for Ex-U.S. Rights to Cx601
Takeda Pharmaceutical Company Limited and TiGenix NV today announced that the companies have entered into an exclusive ex-U.S. license, development and commercialization... Read More