Page 31 - Bio Developments News Today

The company makes available its Process Manager software, which digitizes the end-to-end risk-based cleaning validation lifecycle.

The company secures a positive opinion from the EMA, making it likely that its RSV vaccine will gain approval in Europe by July 2023.

Janssen Biotech has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies.

The FDA has granted accelerated approval for Biogen’s Qalsody (tofersen): making it the first treatment to target a genetic cause of ALS.

The microbiome therapeutic developer Vedanta Biosciences has raked in $106.5m to bankroll the launch of a phase 3 trial of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI).

The US-Chinese company Adcentrx Therapeutics has raised $38m in a Series A+ round to begin a phase 1 trial of its lead candidate antibody-drug conjugate (ADC) later this year.

The new €350m ($386m) biotechnology research center will help power Boehringer Ingelheim’s development of biopharmaceuticals, which account for around 50% of the company’s research pipeline.

The two companies will enter a strategic license agreement to develop ADCs, which gives BMS rights to Tubulis’ technology.

More than a year after imposing a clinical hold on MaaT Pharma’s lead microbiome therapeutic in 2021, the US Food and Drug Administration (FDA) has given clearance for the French firm to begin a phase 3 trial in the US.

Moderna will explore next generation technologies - including quantum computing and artificial intelligence - to advance and accelerate mRNA research via a new partnership with IBM.