Articles tagged with: Melphalan
Press Releases»

San Diego, CA (Press Release) – Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and accelerating the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, announces the official product launch of melphalan hydrochloride for injection (EVOMELA) in China which is the first commercial product launch for CASI. EVOMELA uses Ligand’s Captisol technology in its formulation.
Melphalan hydrochloride for injection (EVOMELA) received market approval by the China National Medical Products Administration (NMPA) for use as high-dose conditioning …
Press Releases»

Rockville, MD (Press Release) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, announces the product launch of EVOMELA® (melphalan for injection) in China which is the first commercial product for the Company.
EVOMELA® received market approval by the China National Medical Products Administration (NMPA) for use as high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplant in patients with multiple myeloma, and as a palliative treatment of patients with multiple myeloma for whom oral …
Press Releases»
- EVOMELA Received FDA Approval for Two Indications:
- High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT)
- Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy
- EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition to the 1 Hour Following Reconstitution
- EVOMELA Does Not Contain Propylene Glycol
- Company Plans to Launch EVOMELA with Existing Sales Force in a Market
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Press Releases»
- The FDA did not identify any clinical deficiency in the CRL
- Company plans to meet with FDA and seek clarification on the CRL
Henderson, NV (Press Release) – Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). A Complete Response Letter is a communication from the FDA that informs companies that an application …
Press Releases»
- PDUFA decision expected October 23, 2015, 10 months from NDA filing.
- Approval is being sought for use as a high-dose conditioning treatment prior to stem cell transplantation in multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
- Spectrum’s formulation is propylene-glycol free and is more stable with a longer use time, which could simplify clinical administration logistics.
- The Company plans to launch this drug with its existing
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Press Releases»
- Approval is being sought for use as a high-dose conditioning treatment prior to stem cell transplantation in multiple myeloma and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
- The Company expects FDA review to take approximately 10 months.
- The Company plans to launch this drug with its existing hematology/oncology sales force next year pending approval.
- Our formulation is free of propylene glycol and does not use a custom solvent
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News, Opinion»

The 2014 International Myeloma Working Group (IMWG) Annual Summit took place in Milan, Italy on June 9 and 10.
The summit is a special meeting organized by the International Myeloma Foundation in which leading myeloma researchers get to brainstorm collectively about the most pressing issues in the field, find ways to collaborate, and plan future laboratory and clinical studies.
The IMWG summit is hailed by most attendees as the most important meeting for myeloma researchers worldwide. It is a unique opportunity for investigators in the field to engage in lively debate but, …