Respiratory

China’s NMPA approves Innovent’s taletrectinib for NSCLC treatment

China's National Medical Products Administration (NMPA) has granted approval to the second new drug application (NDA) of Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI), DOVBLERON (taletrectinib adipate capsule) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Dyadic receives grant from Gates Foundation for RSV antibody development

Dyadic International has received a $3m grant from the Bill & Melinda Gates Foundation to develop monoclonal antibodies (mAbs) for the treatment of respiratory syncytial virus (RSV) and malaria.

AstraZeneca and Daiichi Sankyo submit BLA to FDA for lung cancer treatment

AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).

FDA approves Verona Pharma’s Ohtuvayre for COPD treatment

The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.

FDA grants orphan drug status to Agomab’s AGMB-447 for IPF treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Agomab Therapeutics’ AGMB-447, an inhaled small molecule ALK5-inhibitor, for treating idiopathic pulmonary fibrosis (IPF).

GSK acquires pharma firm Bellus Health for $2bn

GlaxoSmithKline (GSK) has acquired all outstanding shares of Canadian biopharmaceutical firm Bellus Health for a total equity price of $2bn or $14.75 for each share in cash.

China’s NMPA accepts GSK’s drug application review for Nucala to treat SEA

China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).

ReCode Therapeutics to receive strategic investment from Cystic Fibrosis Foundation

ReCode Therapeutics has announced that it will secure a strategic investment from the Cystic Fibrosis Foundation (CF Foundation) to develop its inhaled mRNA-based therapeutic for cystic fibrosis (CF).

UK’s MHRA approves Beyfortus (nirsevimab) to prevent RSV in infants

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given approval to Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.