I-Bluebird Bio News: Izindaba Ezinhle ezivela ku-FDA

Ingabe ulandela izindaba ze-Bluebird Bio? Uma ungekho, yisikhathi sokwazi futhi uvule izaziso zakho kuzo zonke izibuyekezo zakamuva mayelana nale nkampani. Ngoba ihloselwe ukufinyelela ezindaweni eziphakeme nganoma isiphi isikhathi.

Kulindeleke ukuthi amasheya ale nkampani anyuke kakhulu njengoba ikomiti elilulekayo le-Food and Drug Administration (FDA) lincome ukuhlolwa okubili kokwelashwa kwezakhi zofuzo zokuhlola zale nkampani ye-biotech.

Ngakho-ke kungenzeka ukuthi ubonile izitoko zenkampani zikhuphuka zikhuphuka kuphela. Ngolwazi lwakho, ithikha ethi 'BLUE' okungenzeka ukuthi uyibonile ezikrinini ngeyale nkampani ethile. Ngakho-ke ngaphandle kwesimo semakethe sisonke, abaninimasheya bale nkampani bathola ukuphumula okudingeka kakhulu.

I-Essential Bluebird Bio News

Isithombe se-Bluebird bio izindaba

Lena yinkampani yaseCambridge, eMassachusetts ezinze kwi-biotechnology egxile ekuthuthukiseni izindlela zokwelapha ngezakhi zofuzo ezinzima kanye nomdlavuza. Ngaphambilini, okuwukuphela kwesidakamizwa esivunyiwe esivela ku-European Union (EU) kwakuyi-Betigeglogene autotemcel evamise ukubizwa ngegama (Zynteglo).

Ukukukhumbuza, lesi umuthi wesibili obiza kakhulu emhlabeni obiza u-$1.8 million. Ngamathuba amaningi inkampani yabona amasheya ayo enyuka kodwa abelokhu ehla njalo kuze kube manje. Ngokugunyazwa kwezindlela zokwelapha ezimbili, kulindeleke ukuthi ibuyise ithemba elilahlekile ngekusasa layo kubatshalizimali.

Eminye imisebenzi yamapayipi enkampani ihlanganisa ukwelapha ngofuzo iLentiGlobin yeSickle cell disease kanye neCerebral Adrenoleukodystrophy. Iphinde futhi isebenzele ukwelapha i-Acute Myeloid leukemia, i-Merkel-cell carcinoma, i- MAGEA4 solid tumors, kanye ne-Diffuse B-cell lymphoma enkulu.

Iqala uhambo lwayo njengeGenetix Pharmaceuticals ngo-1992 ubuchopho bamalungu obuhlakani be-MIT u-Irving London kanye noPhilippe Leboulch, le nhlangano ye-biotechnology yabona amasheya ayo enyuka afinyelela ku-$178.29 ngo-2018 futhi ngemva kwalokho, base besesimweni sokuwa.

Kodwa ngalezi zindaba, amasheya akhuphuke cishe ngo-28.7% aya ku-4.80 ngoMsombuluko mhla ziyi-14 kuJuni 2022. Amasheya asendleleni yokukhuphuka kwamaphesenti amakhulu kakhulu kule minyaka eyisishiyagalombili edlule, ngokusho kwedatha evela ku-Dow Jones Market Data. Kubalulekile ukwazi ukuthi amasheya ehle ngaphezu kwama-46% kulo nyaka.

Ukweqa kwenani kulindeleke kusukela esincomweni semithi yokwelapha yofuzo ye-biotech yi-Food and Drug Administration. Ngomhla ziyisi-9 kuJuni iKomidi Lokweluleka ngeCellular, Tissue, kanye neGene Therapies le-FDA lancoma i-elivadogene autotmcel noma i-Eli-CEL gene therapy.

Lokhu kwelashwa kuyasebenza ekwelapheni isifo esixhunyaniswe ne-X chromosome, i-cerebral active adrenoleukodystrophy yokuqala. NgoLwesihlanu, indikimba kahulumeni efanayo yancoma i-Betibeglogene autotemcel noma i-beti-cel, lena indlela yokwelapha yesikhathi esisodwa eklanyelwe ukwelapha iziguli ze-beta-thalassemia.

Ngemva kokwelashwa, ngeke kube nesidingo sokumpontshelwa kwamangqamuzana abomvu egazi ezigulini ezithintekile zalesi sifo, ezidinga njalo. I-FDA kulindeleke ukuthi yenze isinqumo esisemthethweni nge-beti-cel ngomhlaka-19 Agasti futhi usuku lwe-Eli-CEL lungomhla ziyi-16 kuSepthemba kulo nyaka.

Isiphetho

Ngalezi zindaba ezinhle, abantu sebeqalile ukuba nesithakazelo kumasheya enkampani futhi yingakho izindaba ze-Bluebird Bio zenza imijikelezo ezindaweni zezimali kuzo zonke izimakethe. Kungakhathaliseki ukuthi intengo iya kuphi, i-bluebird kulindeleke ukuthi izuze kakhulu kulezi zincomo.

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