Remove tag leukaemia
article thumbnail

Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. Other DTxs are aimed at people being treated for breast and lung cancers.

article thumbnail

A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

In contrast to ICIs, which are utilised against solid tumours, cell therapies and bispecifics have been transformational in the haematological cancer settings, with approvals across a range of leukaemias and lymphomas. Cost-related unmet needs also scored highly.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Epigenetics discovery could lead to new class of cancer drugs

Drug Discovery World

New understanding of epigenetics It has been known for more than 20 years that the enzymes placing H3K4me3, a chemical tag added to DNA, are crucial for normal cell development, as well as being linked to leukaemia, breast, bowel and pancreatic cancers.

article thumbnail

NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. Novartis took ownership of the drug in 2015.

Sales 109
article thumbnail

Zynteglo halt re-ignites viral vector safety concerns; analysts

pharmaphorum

Last week, Bluebird said it was pausing its Zynteglo (betibeglogene autotemcel) programme in Europe after a phase 1/2 trial in patients with sickle cell disease (SCD) – another red blood cell disorder – turned up two cases of blood cancers, one of acute myeloid leukaemia (AML) and another of myelodysplastic syndrome (MDS). million in Europe.

article thumbnail

No sign of stopping: The rise of cell and gene therapy

Drug Discovery World

But are these price tags a barrier to access? Patient access A study on the socioeconomic backgrounds of CAR-T patients showed that children from across the spectrum of treatment for acute lymphoblastic leukaemia received similar results. million per dose.

article thumbnail

TG Therapeutics challenges Roche with FDA filing for CLL drug

pharmaphorum

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon.

Drugs 52