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
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
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
Drug Manufacturing June 8, 2023 Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing By PBR Staff Writer Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more
Drug Discovery April 28, 2023 Hansa Biopharma enters into collaboration with Genethon By PBR Staff Writer The partnership, in a clinical trial, will assess the efficacy and safety of imlifidase, Hansa Biopharma’s antibody cleaving enzyme, as a pre-treatment prior to the administration of Genethon’s
Research & Development April 26, 2023 Stablix, Vertex partner to develop targeted protein stabilisation therapies By PBR Staff Writer Under the terms of the deal, Stablix will use its platform to discover new heterobifunctional small molecule drug candidates (RESTORACs) against specified targets which are involved in several
RegulationOphthalmology April 4, 2023 FDA grants orphan drug designation to HuidaGene gene therapy for blindness By PBR Staff Writer The gene therapy is used for the treatment of inherited retinal disease (IRDs) caused by RPE65 mutations. Retina is impacted in patients who suffer from RPE65 mutation-associated IRDs and
Drug DiscoveryResearch & Development March 23, 2023 Dewpoint, Novo Nordisk to identify drug candidates for diabetic complications By PBR Staff Writer Dewpoint’s discovery platform related to biomolecular condensates will be used to identify the drug candidates. The collaboration will enable combination of Novo Nordisk’s expertise in treating diabetes and
Ophthalmology March 7, 2023 Selagine, Grifols agree to develop, commercialise immunoglobulin eye drops By PBR Staff Writer Selagine is a spin-out company from the University of Illinois at Chicago (UIC), while Grifols is a provider of plasma-derived medicines. A biologic drug, an immunoglobulin eye drop
Drug DiscoveryResearch & Development March 1, 2023 Tempus, Pfizer partner for cancer drug development By PBR Staff Writer Under the collaboration, both the companies will work together for further AI and machine learning-driven efforts in therapeutic development. The partnership aims to gather insights more precisely that