Mereo BioPharma and Zydus Lifesciences subsidiary Sentynl Therapeutics have signed an option and licence agreement related to the US commercial and worldwide manufacturing rights to alvelestat, a potential oral treatment for Alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD).
Harbour BioMed and Kelun-Biotech have received approval from China’s National Medical Products Administration (NMPA) for their investigational new drug (IND) application for the HBM7575/SKB575 bispecific antibody intended to treat asthma.
The US Food and Drug Administration (FDA) has granted priority review for MSD’s supplemental biologics license application (sBLA) for Winrevair (sotatercept-csrk).
The US Food and Drug Administration (FDA) has granted fast track designation to Zai Lab’s delta-like ligand (DLL3) antibody-drug conjugate (ADC), ZL-1310, for treating extensive-stage small cell lung cancer (ES-SCLC).
Apnimed has acquired the intellectual property and exclusive worldwide rights from European pharma company Desitin Arzneimittel for developing and commercialising a differentiated carbonic anhydrase inhibitor, sulthiame, targeting sleep apnoea and sleep-related breathing conditions.
The Ministry of Health, Labour and Welfare (MHLW) in Japan has authorised Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating chronic obstructive pulmonary disease (COPD) in adults.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.
The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
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 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.
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