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Novartis plots 'innovative' payment models for pricey Luxturna's EU launch biospectrumasia
December 10, 2018
It’s been almost a year since Spark Therapeutics won a groundbreaking gene therapy approval in the U.S. for Luxturna, and now its marketing partner Novartis has done the same across the pond.
Novartis’ SMA therapy gets US priority review pharmatimes
December 06, 2018
US regulators have accepted for review Novartis’ Biologics License Application for Zolgensma, an investigational gene replacement therapy for the treatment of spinal muscular atrophy (SMA) Type 1.
Novartis takes Xolair follow-up into phase III hives trial pharmaphorum
December 06, 2018
Novartis says it intends to move a drug for chronic spontaneous urticaria (CSU), a severe form of hives, into a phase III programme on the strength of a mid-stage study......
Astellas’ Xospata wins FDA nod in AML, with Daiichi competition looming fiercepharma
December 06, 2018
On an acute myeloid leukemia (AML) roll, the FDA has green-lighted Astellas’ Xospata, also known as gilteritinib. For Astellas, it marks the first step toward challenging Novartis’ Rydapt and likely just a slim head start against Daiichi Sankyo.
Astellas’ Xospata wins AML approval, with Daiichi close behind fiercepharma
December 05, 2018
On an acute myeloid leukemia (AML) roll, the FDA has green-lighted Astellas’ Xospata, also known as gilteritinib. For Astellas, it marks the first step toward challenging Novartis’ Rydapt and likely just a slim head start against Daiichi Sankyo.
Novartis CEO Narasimhan says he was ‘completely blindsided’ by Cohen deal revelation fiercepharma
December 05, 2018
Novartis CEO Vas Narasimhan has repeatedly distanced himself from the dubious $1.2 million in payments the company made to President Donald Trump’s former personal lawyer Michael Cohen as the new administration got rolling.
Novartis unveils strong longer-term Kymriah data at ASH 2018 pharmafile
December 04, 2018
Novartis has lifted the curtain on longer-term analysis data for its CAR-T therapy Kymriah (tisagenlecleucel) at the American Society of Hematology (ASH) Annual Meeting 2018, showing that the treatment demonstrated
Novartis’ Kymriah shows ‘strong efficacy’, ‘durable response’ in new analysis pharmatimes
December 04, 2018
Novartis has released longer-term analyses of data from the ELIANA and JULIET trials showing that its CAR-T cell therapy Kymriah demonstrated “strong efficacy” and “durable responses” in certain blood cancer patients.
FDA accepts Novartis application for Zolgensma to treat SMA pharmaceutical-technology
December 04, 2018
The US Food and Drug Administration (FDA) has agreed to review a biologics licence application (BLA) by Novartis seeking approval for Zolgensma (AVXS-101) for treating spinal muscular atrophy (SMA) Type 1......
Gilead's CAR-T therapy Yescarta shows two-year response duration in large B-cell lymphoma pharmafile
December 04, 2018
Gilead has gone head to head with Novartis at the American Society of Hematology (ASH) Annual Meeting 2018, meeting the latter’s reveal of data on rival Kymriah with study findings of its own CAR-T therapy Yescarta (Axicabtagene Ciloleucel).

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