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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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J&J gets first approval for multiple myeloma bispecific Tecvayli

pharmaphorum

Both bispecifics have arisen out of J&J’s longstanding alliance with Genmab, which also generated anti-CD38 blockbuster Darzalex (daratumumab). Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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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. billion in sales in 2028.

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CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

The new drug is one of two bispecifics for multiple myeloma in the late-stage pipeline of J&J’s Janssen division stemming from its longstanding and fertile collaboration with Danish biotech Genmab, along with talquetamab which binds to CD3 and GPRC5D.

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