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News Breaks
March 14, 2013
07:08 EDTLGND, SPPISpectrum gains rights to Capitsol-enabled Melphalan
Spectrum Pharmaceuticals (SPPI) has gained global development and commercialization rights to Ligand Pharmaceuticals’ (LGND) Captisol-enabled, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
News For SPPI;LGND From The Last 14 Days
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July 30, 2015
09:01 EDTLGNDLigand enters license, supply agreement with Sanofi
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July 24, 2015
12:44 EDTLGNDAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTLGNDFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
09:02 EDTLGNDLigand says Revolade recommended by CHMP for EU approval for SAA
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