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Targeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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Acute myeloid leukaemia (AML)
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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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Sanofi licenses Innate Pharma’s NK cell platform with €25m upfront payment
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
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France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
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FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
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Advanced Biodesign starts first-in-human clinical trial targeting AML
After receiving an approval from France's National Agency for Medicinal Safety and Health Products (ANSM), Advanced BioDesign announced the enrolment of the first patient in its first-in-human clinical trial in acute myeloid leukaemia.
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Gilead and MacroGenics to develop bispecific cancer antibodies
A collaboration agreement between Gilead and biopharma company MacroGenics aims to develop MGD024, a bispecific antibody for treatment of blood cancers.
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Oncolytic viruses: past and present
It is difficult to treat cancer effectively without causing adverse side effects. In this article, Dr Li, Clinical Assistant Professor at the State University of New York and Board Director of ExonanoRNA, describes how an old strategy that never got off the ground has finally been leveraged to deliver safe,…
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Actualising the power of antibody-drug conjugates as cancer therapeutics
Antibody-drug conjugates (ADCs) are designed to be highly-targeted therapies with the potential to maximise the potency of a treatment while reducing unwanted side effects on healthy tissues. Some 20 years after the first ADC product approval, Dominik Schumacher and Jonas Helma-Smets of Tubulis GmbH discuss how improved and optimised technologies…
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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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Teva recalls one lot of IDArubicin Hydrochloride Injection USP
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
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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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Genomic sequencing is a potential key to precision medicine for cancer
A new US study demonstrated that comprehensive genomic sequencing is crucial for the development of precision medicine for cancer patients.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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Highlights of the EMA’s human medicine committee meeting, April 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
