San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that its col­lab­o­rator Janssen Biotech, Inc. (Janssen) has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"Janssen's BLA sub­mission for sub­cu­tane­ous DAR­ZA­LEX® rep­re­sents an im­por­tant devel­op­ment for our ENHANZE® drug de­livery tech­nology business," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are delighted that an ap­­prov­al of the sub­cu­tane­ous for­mu­la­tion may soon …

• BLA sub­mitted to U.S. FDA for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Should this sub­mission lead to an ap­­prov­al, it would provide patients …

Genmab and BliNK Biomedical have entered into a commercial license agree­ment to develop novel bispecific thera­peutics based on BliNK Biomedical’s CD47 anti­bodies and Genmab’s DuoBody® Platform tech­nology.

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that it has entered into an agree­ment with BliNK Biomedical for an exclusive commercial license to certain anti­bodies targeting CD47, for poten­tial devel­op­ment and com­mer­cial­iza­tion into novel bispecific thera­peutics created via Genmab’s pro­pri­e­tary DuoBody Platform tech­nology. This agree­ment sup­ports Genmab’s estab­lish­ed prod­uct pipe­line strategy. Under the terms of the agree­ment, Genmab will pay BliNK Biomedical an up­front fee of USD 2.25 million. BliNK Biomedical is also eli­gible to receive up to approx­i­mately USD 200 million in devel­op­ment, regu­la­tory and commercial mile­stone pay­ments for …

POMALYST®, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, provides a new medication option for patients living with multiple myeloma

Toronto, ON (Press Release) – Celgene Inc. announced today that Health Canada has approved a POMALYST® (poma­lido­mide)-based triplet com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone. This is a new treat­ment option for patients with multiple myeloma (MM) who have received at least one prior treat­ment regi­men that in­cluded REVLIMID® (lena­lido­mide).

POMALYST® is an oral medication taken daily and is indicated, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with MM who have received at least one prior treat­ment regi­men that in­cluded lena­lido­mide.^1,2

"The treat­ment landscape for multiple myeloma has sig­nif­i­cantly changed …

Paris, France (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for review the Biologics License Application (BLA) for isatuximab for the treat­ment of patients with re­lapsed / re­frac­tory multiple myeloma (RRMM). The target action date for the FDA de­ci­sion is April 30, 2020. Isatuximab is an inves­ti­ga­tional mono­clonal anti­body that targets a specific epitope on the CD38 re­cep­tor of a plasma cell.

The BLA is based on pos­i­tive results from ICARIA-MM, an open-label pivotal Phase 3 clin­i­cal trial of isatuximab in patients with RRMM. ICARIA-MM is the first pos­i­tive ran­dom­ized …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

• XPOVIO is the First and Only Nuclear Export Inhibitor Approved by the FDA
• XPOVIO is the First and Only Prescription Medicine Approved by the FDA for the Treatment of Patients with Multiple Myeloma whose Disease is Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and an Anti-CD38 Monoclonal Antibody
• Karyopharm to Hold an Investor Conference Call and Webcast at 1:30 PM ET Today

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed or refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is refractory to at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body. This indi­ca­tion …