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First gene therapy for haemophilia B gets go ahead in Europe

Drug Discovery World

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . Concerns about the high price tag have been raised in an article in Nature, particularly whether it will be affordable for low to middle-income countries. .

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CHMP backs J&Jā€™s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

The CHMP has backed approval of Tecvayli for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies ā€“ including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody ā€“ setting up a full approval in the coming weeks. .

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Deerfield/ Dana-Farberā€™s USD 130 Million Cancer Research Deal; FDA-Approval to BMSā€™ Breyanzi & TG Therapeuticsā€™ Ukoniq; EU Marketing Rights for ViiV Healthcareā€™s Rukobia

Delveinsight

Breyanzi will come with a price tag of USD 410,300 wholesale price, said the company, justifying it after taking into consideration several factors including medical and clinical value, patient value, and societal value. The nod came a few months after the CHMP opinionated positively for the same.

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CHMP backs J&Jā€™s myeloma CAR-T therapy Carvykti

pharmaphorum

The CHMP recommended conditional approval for Carvykti (ciltacabtagene autoleucel or cilta-cel) as a treatment for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer is worsening. The post CHMP backs J&J’s myeloma CAR-T therapy Carvykti appeared first on.

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

With the MAA acceptance, the formal review process by the EMAā€™s Committee for Medicinal Products for Human Use (CHMP) begins. The information contained on our website or any third-party website is not incorporated by reference into this earnings release. View source version on businesswire.com : [link]. Amy Rose 212.733.7410. Source link.