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 …

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 …

• 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

 …

• 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 …

• 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

 …

• 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

 …

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, …