Immunology

Astria Therapeutics’ navenibart gains orphan medicinal status from EC

Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart (STAR-0215) to treat hereditary angioedema (HAE).

Johnson & Johnson seeks FDA approval for generalised myasthenia gravis therapy

Johnson & Johnson has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the approval of nipocalimab, aimed at treating individuals with generalied myasthenia gravis (gMG).

Q32 Bio concludes merger deal with Homology Medicines

Clinical stage biotechnology company Q32 Bio has announced the conclusion of its merger with Homology Medicines, for an undisclosed sum.

Precision receives payments from TG Therapeutics for azer-cel

Precision BioSciences has received upfront cash payment and equity investment totalling $17.5m from TG Therapeutics for an exclusive licence to develop Azercabtagene Zapreleucel (azer-cel).

Kymera receives FDA fast track designation for KT-333

Kymera Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for KT-333 to treat Relapsed/Refractory (R/R) Cutaneous T-Cell Lymphoma (CTCL) and Peripheral T-Cell Lymphoma (PTCL).

EC grants CMA to Janssen’s Talvey for multiple myeloma

The European Commission (EC) has granted conditional marketing authorisation (CMA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey (talquetamab) for the treatment of relapsed and refractory multiple myeloma (RRMM) in adult patients who received a minimum of three prior lines of therapies.

Emergent BioSolutions announces approval from FDA for CYFENDUS vaccine

Emergent BioSolutions has announced receipt of the US Food and Drug Administration’s (FDA) approval for CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted), for post-exposure prophylaxis of disease after suspected or confirmed exposure to Bacillus anthracis in persons aged 18 through 65 years when administered along with recommended antibacterial drugs.

Eli Lilly and Company agrees to acquire DICE Therapeutics

Eli Lilly and Company has signed a definitive agreement to acquire a biopharmaceutical company DICE Therapeutics.

EMA accepts application for Alvotech’s monoclonal antibody AVT04

Alvotech and global pharmaceutical company STADA Arzneimittel (STADA) announced that their Marketing Authorization Application for AVT04, the former’s proposed biosimilar to Stelara (ustekinumab), has been accepted by the European Medicines Agency (EMA).