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CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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Multiple myeloma
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MHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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Non-viral CRISPR could overcome cell and gene therapy bottlenecks
A new approach leveraging high-yield CRISPR could make it easier to re-engineer massive quantities of cells for therapeutic applications.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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Advancing cell therapies – γδ T cells and the combination factor
In this Q&A, Bryan Kobel, Chief Executive Officer of TC Biopharm, discusses innovations in cell therapies, introducing the company’s work in gamma delta (γδ) T-cell technologies and his predictions for the future of cell therapy development.
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Early phase CGT trials: key design elements correlating to distinctive biological characteristics
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
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Adding Sarclisa® provides “unprecedented” multiple myeloma survival, finds trial
Combining Sarclisa® (isatuximab) with carfilzomib and dexamethasone (Kd) resulted in more than three years of progression free survival for relapsed multiple myeloma patients.
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EMA human medicines committee (CHMP) meeting highlights, March 2022
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
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Sanofi and Blackstone €300 million collaboration to advance multiple myeloma treatment
The investment will advance the development of a subcutaneous Sarclisa (isatuximab) formulation for multiple myeloma (MM) treatment.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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New year, new cell and gene therapy collaborations
Here we run down four new research collaborations in the cell and gene therapy sector, announced by Bayer, BMS, Pfizer and Moderna.
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Cilta-cel achieves progression-free survival in multiple myeloma patients
In the Phase Ib/II trial, cilta-cel achieved minimal residual disease negativity in 92 percent of patients and improved survival.
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Five marketing strategies for novel therapeutics
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
