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Hospital Universitario and Josep Carreras develop cell therapy for leukaemia

Pharmaceutical Technology

It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

They state that newer drugs like monoclonal antibodies and kinase inhibitors may benefit from a drug optimisation approach due to their different dose escalation profiles, compared to the cytotoxic chemotherapy drugs.

Dosage 115
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EC grants marketing authorization for Atara’s EBV+ PTLD therapy

Pharmaceutical Technology

Atara Biotherapeutics stated that the prior therapy for solid organ transplant patients includes chemotherapy unless chemotherapy is not suitable. The regulatory approval follows the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency’s (EMA) positive opinion on Ebvallo in October.

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Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to Action

Quality Matters

The center recently issued a white paper on the topic. The impact of such shortages on oncology clinics and their patients can be widespread, touching hundreds of thousands of individuals, affirmed summit presenter Julie Gralow, Executive Vice President and Chief Medical Officer, American Society of Clinical Oncology (ASCO).

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CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

The ADC is already approved in the metastatic setting after chemotherapy or in the case of disease recurrence during or in six months after adjuvant chemotherapy. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging.