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The regulatory decision represents the first new drug application (NDA) approval secured by the speciality pharmaceutical manufacturer. Cosette expects the therapy to be commercially accessible in the US

The partnership focuses on biologics quality control as well as viral and release testing under current good manufacturing practice (cGMP) standards. Magellan recently completed Phase I/II clinical studies

Under the terms of the agreement, the two companies will direct qualified customer opportunities to the other across the development pipeline. A joint governance structure will oversee the

The initiative represents the first time 10x Genomics has widened its clinical research scope past solid tumours to include haematologic malignancies. Under the partnership, the organisations will carry

The therapy is indicated to improve functional capacity and symptoms. The regulatory decision was supported by findings from the double-blind, randomised Phase III SCOUT-HCM trial, which assessed the

The initiative is supported by the Government of Canada through the Federal Economic Development Agency for Southern Ontario. It is designed to help post-seed health science enterprises secure

The agreement grants Tolerance Bio exclusive commercialisation rights outside Japan, whilst Tanabe Pharma retains marketing rights within Japan. The terms also include equity consideration and tiered royalties on

The preclinical T-cell engagers will be developed using Amberstone’s Tumor Microenvironment Activated ThErapeutics (T-MATE) platform. Henlius will select up to two targets under the agreement. The company will

The authorisation allows both treatments to be used for patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial forms or mixed dyslipidaemia. This is said to