Respiratory

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.

CHMP recommends AstraZeneca’s Tezspire for approval to treat severe asthma

AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency as an add-on therapy in patients aged 12 years and above suffering with severe asthma.

Chinese biotech firm Therorna closes $42m Series A financing round

China-based biotech company Therorna has secured $42m in a Series A financing round to support its growth and fuel product pipeline development.