• sBLA & Type II Variation submitted to U.S. FDA and the EMA re­spec­tive­ly, seeking approval of split dosing regi­men for DARZALEX
• Applications seek to update Prescribing Information and Summary of Product Characteristics
• Submissions sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regi­men for DARZALEX^® (dara­tu­mu­mab). The appli­ca­tions request to update the Prescribing Information and Summary of Product Characteristics in order to provide health care professionals the option of splitting …

Raritan, NJ and Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regi­men for DARZALEX^® (dara­tu­mu­mab). The appli­ca­tions seek to update the Prescribing Information and Summary of Product Characteristics to provide health care professionals with the option to split the first in­fusion of DARZALEX^® over two consecutive days. The sub­missions are sup­ported by …

Shanghai, China (Press Release) – On August 8, 2018 Beijing time I-Mab Bio­pharma ("I-Mab"), a Shanghai-based bio­tech com­pany focused on inno­va­tive biologics in on­col­ogy and auto­immune dis­ease, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX;NASDAQ: MOR) an­nounced to­day that I-Mab has Submitted an inves­ti­ga­tional new drug (IND) appli­ca­tion to China National Drug Admin­istra­tion (CNDA) for TJ202 / MOR202, a human mono­clonal anti­body directed against CD38 for the treat­ment of multiple myeloma.

Multiple myeloma is the sec­ond most common blood cancer world­wide. The patient number has gradually in­­creased in China in …

Data from first lead-in patient cohort prompts Data Monitoring Com­mit­tee to rec­om­mend early con­tin­u­a­tion to ran­dom­ized placebo-controlled part 2 of trial

Tel Aviv, Israel (Press Release) – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy and immunology, an­nounced to­day pos­i­tive re­sults from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial com­par­ing BL-8040 in com­bi­na­tion with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobili­za­tion of hema­to­poietic stem cells (HSCs) used for au­tol­o­gous trans­plan­ta­tion in mul­ti­ple myeloma patients.

The open-label, single-arm, lead-in period of the study was de­signed to in­clude up to 30 patients, with Data Monitoring Com­mit­tee (DMC) re­view after com­ple­tion of …

Company to Host Conference Call to Discuss Second Quarter 2018 Financial Results and Recent Business Developments on Tuesday, August 7, 2018 at 8:30 a.m. ET

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced the completion of the rolling sub­mission of a New Drug Application (NDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking accelerated approval for selinexor, its novel, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have pre­vi­ously received the two pro­te­a­some inhibitors (PIs), Velcade® (bor­tez­o­mib) and Kyprolis® (car­filz­o­mib), the two immuno­modu­la­tory drugs (IMiDs), Revlimid® (lena­lido­mide) and Pomalyst® (poma­lido­mide), and the anti-CD38 mono­clonal anti­body Darzalex® (dara­tu­mu­mab) as …

Cambridge, MA (Press Release) – Surface Oncology (NASDAQ: SURF), a clin­i­cal-stage immuno-oncology com­pany devel­op­ing next-generation immuno­therapies that target the tumor micro­en­viron­ment, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to the com­pany’s lead inves­ti­ga­tional can­di­date SRF231 for the treat­ment of patients with multiple myeloma. SRF231 is a fully human anti­body that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells which prevents them from being engulfed and elim­i­nated by macrophages.

“While the poten­tial appli­ca­tions for SRF231 in on­col­ogy are quite broad, …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced 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) for use as frontline (initial) ther­apy.¹ The recom­men­da­tion is for the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone, for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).¹

“Multiple myeloma be­comes harder to treat each time it returns, so …