ApprovalsInfectious Disease July 17, 2023 FDA grants approval for Veklury use in Covid-19 patients By PBR Staff Writer This therapy is intended for use in patients with severe renal impairment including those on dialysis. The latest announcement comes after the decision from European Commission to extend
Marketing & Sales July 14, 2023 TheracosBio’s commercialises type 2 diabetes oral tablet By PBR Staff Writer The FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor Brenzavvy is available as 20 mg tablet and is recommended once daily in the morning with or without food. It
Marketing & Sales July 13, 2023 Astellas Pharma completes acquisition of Iveric Bio By PBR Staff Writer In April this year, Astellas Pharma’s subsidiary agreed to buy 100% of the outstanding shares of Iveric Bio for $40 per share in cash for a total equity value of about
NeurologyApprovals July 12, 2023 TGA grants provisional approval to Hansa’s Idefirix as desensitisation treatment By PBR Staff Writer The provisional approval comes with a duration of two years. It is based on the data from Phase II studies that enrolled highly sensitised patients who received imlifidase
Approvals July 11, 2023 FDA approves label update of Novartis’ Leqvio to treat high LDL-C By PBR Staff Writer The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Leqvio was initially approved by the FDA
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