Tus neeg foob Bristol Myers Squibb Company (BMS) tau foob tus neeg raug foob Xspray Pharma AB hauv New Jersey County rau hnub Wednesday. Daim ntawv foob txog kev ua txhaum cai patent no nrhiav kev tiv thaiv cov neeg raug foob kom tsis txhob ua thiab muag cov tshuaj generic ntawm tus neeg foob cov tshuaj Sprycel.
Sprycel yog siv rau kev kho cov neeg laus thiab cov menyuam yaus uas tau kuaj pom tias muaj ntau hom kab mob leukemia. Cov neeg foob muaj ob daim ntawv pov thawj, daim ntawv pov thawj '725 thiab daim ntawv pov thawj '103 (daim ntawv pov thawj hauv kev foob), hu ua "Txoj kev rau kev npaj 2-aminothiazole-5-aromatic carboxamides ua cov tshuaj kinase inhibitors." Cov ntawv pov thawj tau muab rau xyoo 2009 thiab 2014. Ntxiv rau daim ntawv pov thawj uas tau hais txog, cov neeg foob kuj muaj daim ntawv thov tshuaj tshiab (NDA) rau cov tshuaj noj.
Raws li daim ntawv foob, Xspray tau xa daim ntawv cog lus tsis pub qhia tawm rau FDA uas lawv thov kev tso cai los tsim thiab muag cov tshuaj Sprycel generic. Ntawm lwm yam, Xspray tau tiv tauj cov neeg foob thiab qhia rau lawv tias cov lus thov patent tsis sib haum xeeb tsis raug cai lossis tsis raug ua txhaum los ntawm cov neeg raug foob cov khoom lag luam yav tom ntej.
Tsab ntawv Xspray rau cov neeg foob tau muab kev nkag mus rau qee qhov ntawm Xspray NDA zais cia, tab sis tsis tau muab kev nkag mus rau cov ntaub ntawv tshuaj tseem ceeb rau cov neeg foob. Cov neeg foob tsis muaj kev nkag mus rau cov ntaub ntawv tshuaj tseem ceeb, uas cuam tshuam lawv "lub peev xwm los tshuaj xyuas cov ntaub ntawv cuam tshuam nrog lawv qhov kev tshuaj xyuas kev ua txhaum cai," daim ntawv foob hais.
Daim ntawv foob hais tias Xspray ua txhaum tsawg kawg ib qho kev thov ntawm txhua daim ntawv pov thawj uas muaj lus nug. Tsis tas li ntawd, cov neeg foob piav qhia tias cov neeg raug foob tau tshaj tawm lawv lub hom phiaj los tsim thiab muag lawv cov khoom NDA tam sim ntawd tom qab FDA pom zoo, uas cov neeg foob sib cav tias yuav suav tias yog kev ua txhaum ntxiv ntawm cov ntawv pov thawj uas tau hais los saum toj no.
BMS tau sib cav hais tias yog tias cov neeg raug foob tsis raug tiv thaiv kom tsis txhob ua txhaum ntxiv rau cov ntawv pov thawj uas muaj lus nug, lawv yuav raug "kev puas tsuaj loj heev thiab tsis tuaj yeem kho tau". Daim ntawv foob teev ob qhov kev ua txhaum cai ntawm daim ntawv pov thawj. Cov neeg foob tab tom nrhiav kev txiav txim siab zoo rau txhua qhov kev foob, kev txwv tsis pub ua txhaum ntxiv, kev txiav txim kom ntseeg tau tias cov khoom lag luam NDA ntawm cov neeg raug foob yuav tsis raug tsim ua ntej daim ntawv pov thawj uas muaj lus nug tas sij hawm, kev pab nyiaj txiag yog tias cov neeg raug foob txhawb nqa lawv cov khoom lag luam NDA, thiab ntau ntxiv.
Lub sijhawm tshaj tawm: Plaub Hlis-12-2023