Results from two clin­i­cal trials (ELOQUENT-2 & CA204-009), each combining Empliciti with a dif­fer­en­t standard of care regi­men in­cluded in the sub­mission

Empliciti is poised to be the first-in-class SLAMF7-directed immunostimulatory anti­body

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the Euro­pean Medicines Agency (EMA) val­i­dated for review the Marketing Authori­za­tion Appli­ca­tion (MAA) for Empliciti, an inves­ti­ga­tional Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory anti­body, for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy in adult patients who have re­ceived one or more prior ther­a­pies. The appli­ca­tion was granted ac­cel­er­ated assess­ment by the EMA’s Com­mit­tee for Medicinal Products for Human Use (CHMP).

“We be­lieve the CHMP’s ac­ceptance for an ac­cel­er­ated assess­ment reflects the need for a new treat­ment op­tion for …

Submission of rolling BLA to US FDA for dara­tu­mu­mab in multiple myeloma com­pleted by Janssen Biotech, Inc.

Completion of sub­mission triggers USD 15 million mile­stone pay­ment to Genmab

Copenhagen, Denmark (Press Release) — Genmab A/S (OMX: GEN) announced its licensing partner Janssen Biotech, Inc. has com­pleted the rolling sub­mission of the Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple mye­lo­ma who have received at least three prior lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a PI and an IMiD. In May, 2013, dara­tu­mu­mab was granted a Break­through Therapy …

Janssen Biotech, Inc. ini­ti­ates rolling sub­mission of BLA to U.S. FDA for dara­tu­mu­mab in double refractory multiple myeloma

Submission based on data from Phase II study (Sirius MMY2002)

Copenhagen (Press Release) – Genmab A/S (OMX: GEN) announced today its licensing partner Janssen Biotech, Inc. has ini­ti­ated a rolling sub­mission of a Biologics License Application (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for dara­tu­mu­mab. The sub­mission is for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­tea­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­tea­some inhibitor and an IMiD. A rolling sub­mission allows com­pleted portions of the …

Marks a critical step for­ward for the inves­ti­ga­tional human mono­clonal anti­body (mAb)

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) has ini­ti­ated the rolling sub­mission of its Biologic License Application (BLA) for dara­tu­mu­mab to the U.S. Food and Drug Admin­is­tra­tion (FDA) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are double refractory to a PI and an IMiD. Dara­tu­mu­mab – an inves­ti­ga­tional human anti-CD38 mono­clonal anti­body – received Break­through Therapy Desig­na­tion by the FDA for this set of patients …

MorphoSys Regains Rights to MOR202 Antibody Against CD38 and
Updates its Financial Guidance for 2015
Conference call on Friday, March 27, 2015, at 1:00pm CET (12:00pm GMT/8:00am EST)

Martinsried / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that it has regained rights to MOR202 from Celgene Corpo­ra­tion. The com­pa­nies have mutually agreed to terminate their co-development and co-promotion agree­ment for MOR202. Clinical devel­op­ment of MOR202, which cur­rently involves a MorphoSys-sponsored phase 1/2a trial in re­lapsed or refractory multiple myeloma patients, will con­tinue as planned. This trial in­cludes combi­na­tion cohorts with lena­lido­mide and poma­lido­mide which will be provided to MorphoSys by …

• First study of dara­tu­mu­mab in smoldering multiple myeloma
• Study expected to start in  2015

Copenhagen, Denmark (Press Release) - Genmab A/S (OMX: GEN) announced today that its col­lab­o­ra­tion partner, Janssen Biotech, Inc. (Janssen) plans to start a Phase II study of dara­tu­mu­mab in smol­der­ing multiple myeloma.  The study (SMM2001) will eval­u­ate three dif­fer­en­t dose schedules of dara­tu­mu­mab for the treat­ment of smol­der­ing multiple myeloma.  The study is ex­pec­ted to start enrolling patients in 2015.

"We are pleased to announce this study, which illustrates that the devel­op­ment plan for dara­tu­mu­mab encompasses all stages of multiple myeloma. …

• This Phase I trial will test the safety and tolerability of lirilumab (BMS-986015) in combination with elotuzumab (BMS-901608) in patients with multiple myeloma
• This new Phase I initiated by Bristol-Myers Squibb is the first combination trial of lirilumab in a hematological tumor type

Marseille, France (Press Release) - Innate Pharma SA (the "company" -  euronext paris:FR0010331421 - IPH), the innate immunity com­pany devel­op­ing first-in-class thera­peutic anti­bodies for cancer and in­flam­ma­tory dis­eases, to­day an­nounced that a new Phase I com­bi­na­tion trial with lirilumab, a …