• DARZALEX split dosing regi­men approved by U.S. FDA
• Provides health­care professionals with option to split first DARZALEX in­fusion over two consecutive days
• Approval sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved a split dosing regi­men for DARZALEX® (dara­tu­mu­mab). The approval will be in­cluded in an update to the Prescribing Infor­ma­tion in order to provide health­care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The supple­mental Biologics License Application (sBLA) was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in July, 2018. The split dosing …

North Chicago, IL and Menlo Park, CA (Press Release) – AbbVie (NYSE: ABBV), Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that they have entered a global strategic trans­­action to develop and com­mer­cial­ize TNB-383B, a BCMA-targeting immuno­therapeutic for the poten­tial treat­ment of multiple myeloma.

B-cell maturation an­ti­gen (BCMA) has emerged as an attractive target for multiple myeloma thera­peutics. TNB-383B is a bispecific anti­body that simultaneously targets BCMA and CD3, utilizing Teneobio's unique anti-CD3 plat­form. Through this dual targeting mech­a­nism, TNB-383B is designed to direct the body's own immune system to target and …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Admin­istra­tion (FDA) is scheduled to review data sup­porting the Company’s New Drug Application (NDA) requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­pound, at a meeting on February 26, 2019 at 12:30 p.m. ET. The proposed indi­ca­tion to be discussed at this upcoming ODAC meeting is for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with refractory …

• FT516 off-the-shelf NK cell cancer immuno­therapy cleared for clin­i­cal in­ves­ti­ga­tion by FDA
• Product can­di­date derived from clonal master iPSC line engi­neered with novel CD16 Fc re­cep­tor
• Clinical trial to eval­u­ate multi-dose cycles of FT516 for treat­ment of hema­to­logic malig­nancies, in­clud­ing in combi­nation with targeted anti­body ther­apy

San Diego, CA (Press Release) – Fate Thera­peutics, Inc. (NASDAQ: FATE), a clin­i­cal-stage bio­pharma­ceu­tical com­pany ded­i­cated to the devel­op­ment of pro­grammed cellular immuno­therapies for cancer and immune disorders, an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has allowed its Inves­ti­ga­tional New Drug (IND) appli­ca­tion for FT516, the Com­pany’s off-the-shelf natural killer (NK) cell prod­uct can­di­date derived from a clonal master induced pluripotent stem cell (iPSC) line engi­neered to express a novel CD16 Fc re­cep­tor. FT516 is the first-ever cell …

• Study eval­u­ated the benefit of isatuximab in com­bi­na­tion with standard of care in prolonging pro­gres­sion free sur­vival as com­pared to standard of care in patients with re­lapsed / re­frac­tory multiple myeloma
• First ran­dom­ized Phase 3 trial to eval­u­ate the benefit of adding a mono­clonal anti­body to poma­lido­mide and dexa­meth­a­sone for treat­ment of re­lapsed / re­frac­tory multiple myeloma
• Multiple ongoing Phase 3 studies with isatuximab, an inves­ti­ga­tional agent, in com­bi­na­tion with standard of care ther­a­pies in newly diag­nosed and re­lapsed / re­frac­tory multiple myeloma

Paris, France (Press Release) – The pivotal Phase 3 trial of isatuximab in patients with re­lapsed / re­frac­tory multiple myeloma met the pri­mary end­point of prolonging pro­gres­sion free sur­vival in patients treated with isatuximab in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone alone (standard of care).

Results will be sub­mitted to an upcoming medical meeting and are antic­i­pated to form the basis of regu­la­tory sub­missions planned for later this year.

"We are ex­cited by these results, …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute. As a result of this, the parties to the dispute have agreed to drop the mutual claims related to this lit­i­ga­tion.

On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second …

• Genmab, Janssen and MorphoSys have agreed to end the patent infringement lawsuit launched by MorphoSys AG relating to DARZALEX
• On Jan­u­ary­ 25, 2019, a summary judge­ment de­ci­sion ruled that the three MorphoSys patents were invalid
• As a result of the agree­ment, MorphoSys will not appeal the summary judge­ment of invalidity and Genmab and Janssen will not pursue their inequitable conduct claim

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the patent infringement lawsuit launched by MorphoSys relating to DARZALEX® is finally over.

As pre­vi­ously reported, on Jan­u­ary­ 25, 2019, the U.S. District Court of the District of Delaware ruled that all three patents that MorphoSys had asserted against Genmab and Janssen Biotech, Inc. (Janssen) are invalid. As noted at that time, Genmab and Janssen’s alle­ga­tions that the patents were unenforceable for inequitable conduct remained to …