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PharmaShots Weekly Snapshots (January 23 - 27, 2023)

PharmaShots

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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PharmaShots Weekly Snapshots (May 22 - 26, 2023)

PharmaShots

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

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Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

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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.

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Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development” More than 20 years ago, the first ADC, Mylotarg, was approved for use in patients with relapsed or refractory acute myeloid leukaemia (AML). The culmination of two decades of learning.