New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing im­mu­no­ther­apies based on gene-edited allo­geneic CAR T-cells (UCART), to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the clin­i­cal hold on the Phase 1 MELANI-01 trial eval­u­ating the UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency’s re­quests, which in­clude ad­just­ments to the MELANI-01 clin­i­cal protocol de­signed to en­hance patient safety. …

Berlin, CT (Press Release) – Breckenridge Pharma­ceu­tical, Inc. an­nounced to­day that the U.S. Food and Drug Admin­istra­tion has ap­prov­ed Breckenridge's Abbreviated New Drug Appli­ca­tion for Poma­lido­mide Capsules (generic for Pomalyst®).

Breckenridge has part­nered with Natco Pharma Limited for the de­vel­op­ment and manu­fac­ture of this prod­uct. According to in­dus­try sales data, Pomalyst had annual sales of $957 mil­lion during the twelve months ending Sep­tem­ber 2020. Celgene, Breckenridge and Natco have set­tled the U.S. district court lit­i­ga­tion with respect to this prod­uct.

About Breckenridge

Breckenridge Pharma­ceu­tical, Inc., a sub­sid­i­ary of Towa Pharma­ceu­tical (Osaka, Japan), part­ners …

Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

Stockholm, Sweden (Press Release) – XNK Thera­peutics AB ("XNK") to­day an­nounced it has re­ceived Orphan Drug Desig­na­tion (ODD) from the U.S. Food and Drug Admin­istra­tion (FDA) for its lead­ing inves­ti­ga­tional drug can­di­date in the treat­ment of mul­ti­ple myeloma (MM).

Receiving ODD status from the FDA for the treat­ment of mul­ti­ple myeloma is a crit­i­cal next step for the de­vel­op­ment of XNK's lead­ing inves­ti­ga­tional drug can­di­date. XNK has already re­ceived ODD status in the EU.

"Obtaining an ODD by the FDA is a sig­nif­i­cant mile­stone for XNK and our goal of taking the present …

Adds pro­pri­e­tary next gen­er­a­tion nat­u­ral killer (K-NK) cell plat­form and pipe­line of cell-based can­cer im­mune-therapeutics and infectious dis­ease ther­a­pies

Paris, France and Amsterdam, Netherlands (Press Release) – Sanofi and Kiadis, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive ‘off the shelf’ nat­u­ral killer (NK) cell based med­i­cines for the treat­ment of life-threatening dis­eases, entered into a definitive agree­ment under which Sanofi will make a pub­lic offer (sub­ject to satisfaction of cer­tain customary con­di­tions) to acquire the entire share capital of Kiadis for EUR 5.45 per share, rep­re­senting an aggregate adjusted equity value of €308m¹.

“We be­lieve the Kiadis ‘off the shelf’ K-NK cell tech­nology plat­form will have broad appli­ca­tion against liquid and solid tumors, …

Enrollment to cease im­medi­ately; top­line data antic­i­pated in H1 2021

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced pos­i­tive re­sults from a planned interim analysis of the on­go­ing GENESIS Phase 3 trial of motix­a­fortide for stem cell mo­bi­li­za­tion (SCM) in mul­ti­ple myeloma patients.

At a meeting of the study's in­de­pen­dent Data Monitoring Com­mit­tee (DMC), a planned interim analysis of the study's pri­mary end­point was con­ducted in­de­pen­dent­ly by the DMC. Based on the statistically sig­nif­i­cant evi­dence favoring treat­ment with motix­a­fortide, the DMC issued a recom­men­da­tion to the Com­pany that patient …

• Second part of the Phase 3 CASSI­O­PEIA study of dara­tu­mu­mab as main­te­nance treat­ment for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant met the pri­mary end­point of pro­gres­sion-free sur­vival at a pre-planned interim analysis
• Independent Data Mon­i­tor­ing Com­mit­tee rec­om­mends unblinding the study re­sults
• Based on the data, Janssen plans to discuss the po­ten­tial for a regu­la­tory sub­mission with health author­i­ties

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day pos­i­tive top­line re­sults from the sec­ond part of the Phase 3 CASSI­O­PEIA (MMY3006) study of dara­tu­mu­mab mono­therapy as main­te­nance treat­ment versus observation (no treat­ment) for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sec­ond part of the study, which is being con­ducted by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for He­ma­tol­ogy On­col­ogy (HOVON) and …