pharmaphorum

JUNE 12, 2022

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8

FDA 59

FDA 59

pharmaphorum

JANUARY 11, 2021

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. Meanwhile the as-yet unnamed oncology company will spin off under the leadership of bluebird’s current chief executive Nick Leschly. million price tag.

FDA 66

FDA 66

pharmaphorum

AUGUST 18, 2022

bluebird bio’s Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require regular blood transfusions. bluebird has opted to launch it at a cost of $2.8 The post bluebird unveils $2.8m

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FDA Insurance 52

Pharmaceutical Technology

NOVEMBER 9, 2022

Reimbursement has been a major obstacle in the EU for expensive gene therapies, including bluebird bio’s beta-thalassemia therapy Zynteglo. The European Commission withdrew the marketing authorisation of Zynteglo, at the request of bluebird bio, in March 2022. million price tag. million ($1.8 million at the time).

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FDA 111

pharmaphorum

AUGUST 25, 2022

It joins a number of other BCMA-directed therapies for multiple myeloma, including GSK’s first-to-market antibody-drug conjugate Blenrep (belantamab mafodotin), Bristol-Myers Squibb/bluebird bio’s CAR-T therapy Abecma (idecabtagene vicleucel) and J&J/Legend Biotech’s CAR-T Carvykti (ciltacabtagene autoleucel).

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FDA Immunization 98

pharmaphorum

JULY 25, 2022

.” GSK’s antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) was the first BCMA-targeting drug to reach the market in 2020, and has since been joined by Carvykti as well as Bristol-Myers Squibb and bluebird bio rival CAR-T therapy Abecma (idecabtagene vicleucel).

FDA 52

FDA 52

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

FEBRUARY 16, 2021

It’s back to the drawing board for bluebird bio and its discussions with NICE, which has rejected its beta thalassaemia gene therapy Zynteglo for regular NHS use in first draft guidance. The post bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy appeared first on. million in Europe.

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pharmaphorum

AUGUST 26, 2022

BioMarin will no doubt have an eye on the earlier experience of bluebird bio, which secured EU approval for rare disease gene therapy Zynteglo (betibeglogene autotemcel) in 2019 for beta thalassaemia with a price tag of around €1.6 million spread over five years.

FDA 111

FDA 111

pharmaphorum

MARCH 27, 2022

The decision comes less than a month after Carvykti was approved by the FDA as a fifth-line therapy for multiple myeloma, teeing up a tussle in the market with Bristol-Myers Squibb and bluebird bio spinout 2seventy’s Abecma (idecabtagene autoleucel) which was approved for a similar indication last year.

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Labelling Immunization FDA 98

STAT

DECEMBER 15, 2023

But Bluebird’s $3.1 million price tag is nearly $1 million higher than its rivals’, even though its own treatment has a serious safety warning about a blood cancer risk. Although time is running out, you could plan an end-of-year getaway. Or you could make a point of reaching out to someone special. But be safe.

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Insurance FDA 97