Janssen’s first-in-class CD38-directed mono­clonal anti­body now rec­om­mended for approval earlier in the treat­ment path­way in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rec­om­mended broadening the existing mar­ket­ing authori­sa­tion for DARZALEX®▼ (dara­tu­mu­mab).¹ If approved by the European Com­mis­sion, dara­tu­mu­mab can be used in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone; or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at …

• Oral REVLIMID® is the first and only medicine licensed in Europe for use as post-autologous stem cell trans­plan­ta­tion main­te­nance ther­apy in multiple myeloma
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of multiple myeloma

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that the European Com­mis­sion (EC) has approved REVLIMID® (lena­lido­mide) as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). REVLIMID® is the first and only licensed main­te­nance treat­ment avail­able to these patients.

The REVLIMID® Marketing Authorisation has been updated to in­clude this new indi­ca­tion, which expands on the existing multiple myeloma indi­ca­tions as …

• REVLIMID is the first and only treat­ment approved for main­te­nance fol­low­ing auto-HSCT
• Updated data from two large, ran­domized, controlled studies dem­onstrated median pro­gres­sion-free survival (PFS) advantages of 3.8 and 1.9 years, re­spec­tive­ly, in favor of patients receiving REVLIMID compared to no main­te­nance
• Median over­all survival (OS) for patients receiving REVLIMID in each study was 9.3 years and 8.8 years, re­spec­tive­ly, compared to 7 and 7.3 years for no main­te­nance in a descriptive analysis (studies not powered for OS)
• Approval enables Celgene to provide patients with treat­ment options across the multiple myeloma spectrum

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has expanded the existing indi­ca­tion for REVLIMID (lena­lido­mide) 10 mg capsules to in­clude use for patients with multiple myeloma as main­te­nance ther­apy fol­low­ing au­tol­o­gous hema­to­poietic stem cell trans­plant (auto-HSCT). The expanded indi­ca­tion makes REVLIMID the first and only treat­ment to receive FDA approval for main­te­nance use fol­low­ing auto-HSCT.

“Autologous stem cell trans­plant after induction ther­apy is …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that it has added a second patent with US Patent Number 9,200,061 to its lawsuit against Janssen Biotech, and Genmab, A/S. This patent claims methods of treating hema­to­logic cancer asso­ci­ated with the undesired presence of CD38-positive cells by admin­istering anti­bodies that bind to a specific region of the target molecule, CD38. In a hearing that took place on Feb­ru­ary 6, 2017 the District Court granted MorphoSys's request to add the 9,200,061 patent to the …

• Phase 1 trial will eval­u­ate Actimab-M in treating patients with multiple myeloma who are unresponsive to cur­rently avail­able ther­a­pies
• Clinical trial ini­ti­ated at Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, TX to be conducted by Principal Investigator and Trial Sponsor, Dr. Yair Levy
• Clinical pipe­line now in­cludes Iomab-B pivotal Phase 3 trial, Actimab-A Phase 2 trial and Actimab-M  Phase 1 trial

New York, NY (Press Release) -- Actinium Pharma­ceu­ticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a bio­pharma­ceu­tical …

St. Louis, MO (Press Release) – A com­pound found in green tea could have lifesaving poten­tial for patients with multiple myeloma and amyloidosis, who face often-fatal medical com­pli­ca­tions asso­ci­ated with bone-marrow disorders, according to a team of engi­neers at Washington University in St. Louis and their German col­lab­o­rators.

Jan Bieschke, assistant professor of biomedical engi­neer­ing at the School of Engineering & Applied Science, studies how proteins fold and shape themselves, and how these processes can con­trib­ute to a variety of diseases. He says the com­pound epigallocatechine-3-gallate (EGCG), a polyphenol found in green …

• REVLIMID® is the first and only medicine granted positive CHMP opinion for post-Autologous Stem Cell Transplantation (ASCT) main­te­nance ther­apy in MM
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of MM

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID® as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma (MM) who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). Once approved by the European Com­mis­sion, REVLIMID® will be the first and only licensed main­te­nance treat­ment avail­able to …