RegulationClinical Trials July 5, 2023 Taiho’s LYTGOBI tablets receive European Commission marketing authorisation By PBR Staff Writer The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy,
Clinical TrialsRegulation July 4, 2023 FDA grants IND clearance for Phase I/IIa trial of Skyline’s SKG0106 By PBR Staff Writer A single-time, recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease, SKG0106 is administered intravitreally. The global Phase I trial will begin shortly. SKG0106 consists of a new AAV
Inflammation July 3, 2023 Sandoz makes available biosimilar of Humira in US By PBR Staff Writer The treatment is indicated for usage in areas that are not covered by the reference medicine Humira’s regulatory exclusivity. The indications include inflammatory ailments namely juvenile idiopathic arthritis,
Respiratory June 30, 2023 GSK acquires pharma firm Bellus Health for $2bn By PBR Staff Writer Bellus focuses on improving the lives of individuals suffering from persistent cough. In April this year, GSK reached an agreement for the acquisition of Bellus Health. The takeover comprises the
RegulationOphthalmology June 29, 2023 Regeneron receives FDA response letter for aflibercept’s BLA By PBR Staff Writer The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical
HaematologyRegulation June 28, 2023 FDA accepts BLA for Pfizer’s haemophilia B gene therapy By PBR Staff Writer Intended to treat adult patients, fidanacogene elaparvovec is an investigational therapy that comprises a bio-engineered adeno-associated virus (AAV) capsid and a human coagulation Factor IX (FIX) gene variant.
Regulation June 27, 2023 GSK’s daprodustat obtains positive opinion from EMA CHMP By PBR Staff Writer An oral inhibitor of hypoxia-inducible factor prolyl hydroxylase, daprodustat is intended for usage in adult patients who are on chronic maintenance dialysis. The company is developing the therapy
Infectious Disease June 26, 2023 MPP signs sublicence agreements for Shionogi’s Ensitrelvir By PBR Staff Writer Ensitrelvir is a COVID antiviral presently approved in Japan and being analysed in clinical trials outside of the country. The sublicence agreements were inked with three generic manufacturing
Central Nervous SystemNeurology June 23, 2023 Biotech AltPep scores around $53m in Series B funding round By PBR Staff Writer Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new
Anaemia/ Vitamins June 22, 2023 FDA grants priority review to bluebird bio’s BLA for SCD gene therapy By PBR Staff Writer Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events. A modified form of