Patents asserted against Janssen Biotech, Inc. & Genmab in the United States have been declared invalid by summary judg­ment

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s col­lab­o­ration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judg­ment. The patent infringement lawsuit was ini­ti­ated by MorphoSys against Genmab and Janssen in April 2016 asserting that activ­i­ties with DARZALEX (dara­tu­mu­mab) in the United States infringe its U.S. patents, and the case has been pend­ing before the U.S. District Court of Delaware. The …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Seg­ment, MDAX & TecDAX; NASDAQ: MOR) announces that it was informed today that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held No­vem­ber 27, 2018, has ruled in a Court Order on Jan­u­ary­ 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746; 9,200,061 and 9,758,590 are invalid. The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech …

• First part of regu­la­tory package submitted to the U.S. FDA for label expansion of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• The U.S. FDA plan to review the sub­mission under their Real-Time Oncology Review Pilot Program
• Application based on data from Phase III MAIA (MMY3008) study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc. (Janssen), has submitted the first part of a regu­la­tory sub­mission to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for a label expansion to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT).  The U.S. FDA plans to …

Shanghai, China and New York, NY (Press Release) – Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a bio­pharma­ceu­tical firm engaged in the devel­op­ment of immuno­therapies for cancer and stem cell ther­a­pies for degenerative diseases, today announces the initiation of patient recruitment to sup­port the study of anti-BCMA CAR-T ther­apy targeting re­lapsed and refractory multiple myeloma in China.

"China has seen a sub­stan­tial in­­crease in the in­ci­dence of multiple myeloma. As a drug devel­op­ment com­pany, BCMA is the first of multiple assets that CBMG is ad­vanc­ing amongst our on­col­ogy pipe­line beyond our col­lab­o­ration with a …

Selinexor Marketing Authori­za­tion Appli­ca­tion to be Reviewed Under Accelerated Assessment

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, to­day an­nounced that it has sub­mitted a Mar­ket­ing Authori­za­tion Appli­ca­tion (MAA) to the Euro­pean Medicines Agency (EMA) for selinexor, the Com­pany’s first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, re­quest­ing con­di­tional ap­prov­al for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM) who have re­ceived at least three prior lines of ther­apy and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor (PI), one immuno­modu­la­tory agent (IMiD), and one anti-CD38 mono­clonal anti­body (mAb), and to their …

Median over­all sur­vival of 22.0 months observed in Cohorts 1-4

Florham Park, NJ (Press Release) – Cellectar Biosciences (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced median over­all sur­vival (mOS) in Cohorts 1-4 of the com­pany’s on­go­ing Phase 1 clin­i­cal trial eval­u­ating CLR 131 for the treat­ment of re­lapsed / re­frac­tory (R/R) mul­ti­ple myeloma (MM). The results showed mOS of 22.0 months among 15 patients, all of whom were heavily pre­treated, averaging five prior lines of sys­temic ther­apy. Each patient in Cohorts 1-4 of this dose-escalation study re­ceived a …

• Highly Complementary Portfolios with Leading Franchises in Oncology, Immunology and In­flam­ma­tion and Cardiovascular Disease
• Significantly Expands Phase III Assets with Six Expected Near-Term Product Launches, Rep­re­sent­ing Greater Than $15 Billion in Revenue Potential
• Registrational Trial Opportunities and Early-Stage Pipeline Position Combined Company for Sus­tained Leadership Underpinned by Cutting-Edge Technologies and Discovery Platforms
• Strong Combined Cash Flows, Enhanced Margins and EPS Accretion of Greater Than 40% in First Full Year
• Approximately $2.5 Billion of Expected Run-Rate Cost Synergies to Be Achieved by 2022

New York, NY and Summit, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that they have entered into a definitive merger agree­ment under which Bristol-Myers Squibb will acquire Celgene in a cash and stock trans­­action with an equity value of approx­i­mately $74 billion. Under the terms of the agree­ment, Celgene share­holders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share …