Approvals July 10, 2023 FDA clears 280Bio’s IND to start Phase I trial of YL-17231 By PBR Staff Writer The study will be carried out at several US-based clinical cancer research centers including the MD Anderson Cancer Center in Houston, Texas. 280Bio intends to enroll patients for
Approvals July 7, 2023 European Commission grants full MA to Novavax’s Covid-19 vaccine By PBR Staff Writer The full MA is based on positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use, and replaces the conditional Marketing Authorization. As
Regulation July 6, 2023 NMPA grants approval to Toray’s antipruritus medication By PBR Staff Writer The approval was based on an import approval application filed by Toray and its partner 3SBio in November 2021 for alleviating pruritus in people with chronic liver disease.
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,
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
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