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
Immunology June 21, 2023 Eli Lilly and Company agrees to acquire DICE Therapeutics By PBR Staff Writer Under the deal terms, Lilly will begin a tender offer to purchase all outstanding shares of DICE for an acquisition price of $48 per share in cash, which translates to a total
Regulation June 20, 2023 F2G receives Complete Response Letter for olorofim NDA By PBR Staff Writer The NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023. As per the CRL, the regulatory body
Production & Sales June 19, 2023 Rosemont Pharmaceuticals acquires Lucis Pharma By PBR Staff Writer With the acquisition, Rosemont will expand its existing portfolio and gain access to the new pipeline of products, providing lifesaving pharmaceuticals across the UK and within overseas markets.
Drug Discovery June 16, 2023 Sandoz launches action plan to improve access to biosimilar medicines By PBR Staff Writer Dubbed Act4Biosimilars Action Plan, the new roadmap has been designed to boost the adoption of global biosimilar products by at least 30% points in more than 30 countries