• Amgen to Acquire 20.5% Stake in BeiGene for Approximately $2.7 Billion in Cash
• BeiGene to Commercialize XGEVA® (denosumab), KYPROLIS® (car­filz­o­mib) and BLINCYTO® (blinatumomab) in China
• Companies to Collaborate on Advancing Amgen's Innovative Oncology Pipeline in China
• Amgen Will Continue to Commercialize its Non-Oncology Product Portfolio in China
• Amgen to Host Call for Investors Today at 2 p.m. PT

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) announced today that it has entered into a stra­te­gic col­lab­o­ration with BeiGene that will sig­nif­i­cantly accelerate Amgen's plans to ex­pand its on­col­ogy presence in China, the world's second-largest pharma­ceu­tical mar­ket. BeiGene is a research-based, on­col­ogy-focused bio­tech­nology com­pany with an estab­lish­ed and highly ex­peri­enced team in China, in­clud­ing a 700-person commercial or­ga­ni­za­tion and a 600-person clin­i­cal devel­op­ment or­ga­ni­za­tion.

"This stra­te­gic col­lab­o­ration with BeiGene will enable Amgen …

This DARZALEX® com­bi­na­tion regi­men reduced the risk of dis­ease pro­gres­sion or death by 44% in newly diag­nosed patients who are trans­plant in­eli­gible

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced that Health Canada recently approved under Priority Review DARZALEX® (dara­tu­mu­mab), in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd), for newly diag­nosed patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The approval is based on results from the Phase 3 MAIA clin­i­cal study published in the New England Journal of Medicine, which showed the DARZALEX®-Rd com­bi­na­tion reduced the risk of dis­ease pro­gres­sion or death by 44 per cent com­pared to treat­ment with Rd alone.¹

Multiple …

Cellectis’ UCARTCS1 MELANI-01 Trial Commenced at MD Anderson Cancer Center

New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited off-the-shelf CAR T-cells (UCART), to­day an­nounced the Com­pany has dosed the first patient in its UCARTCS1 clin­i­cal trial, MELANI-01, the first allo­geneic off-the-shelf CAR-T prod­uct can­di­date the U.S. Food and Drug Admin­istra­tion (FDA) has cleared to enter into clin­i­cal devel­op­ment for re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM). The UCARTCS1 clin­i­cal trial is a Phase 1 dose-escalation study to eval­u­ate the safety, ex­pan­sion, persistence and clin­i­cal ac­­tiv­ity of UCARTCS1 cells …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co. Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany to­day an­nounced that the United States Food and Drug Admin­istra­tion (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) desig­na­tion to its inves­ti­ga­tional CT053 CAR-T cell ther­apy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cell ther­apy for the treat­ment of re­lapsed and/or re­frac­tory mul­ti­ple myeloma (rrMM).

RMAT desig­na­tion was based on clin­i­cal data from an on­go­ing CT053 phase 1 study in heavily pre-treated mul­ti­ple myeloma patients in China. Updated data from CT053 …

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) to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) for patients with newly diag­nosed multiple myeloma (NDMM) who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“As multiple myeloma can be­come more complex with each relapse, it is im­por­tant that patients receive the latest treat­ment options with the …

• CHMP issued a pos­i­tive opinion for DARZALEX® in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III MAIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for newly diag­nosed adult patients with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Type …

Geneva, Switzerland and Newark, California (Press Release) – Selexis SA and Teneobio, Inc. announced today that they have signed three commercial license agree­ments (CLAs) for the devel­op­ment of Teneobio’s Human Heavy-Chain Antibodies (UniAbs™), a new class of multi-specific biologics, for the treat­ment of multiple myeloma, lym­phoma and prostate cancer. The CLAs ex­pand the com­pa­nies’ pre­vi­ously estab­lish­ed rela­tion­ship, in­clud­ing a service agree­ment signed be­tween Teneobio and Selexis in De­cem­ber 2018.

Through each new CLA, Selexis will provide Teneobio with access to high per­for­mance research cell banks (RCBs) devel­oped using the Selexis SUREtechnology Platform™, with …