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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.

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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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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.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

OPQ is engaged in various steps to develop QMM, including a quality rating system; activities such as stakeholder meetings and a white paper released in April on the importance of QMM and an upcoming advisory committee meeting are further steps toward that goal.

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