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News
Regeneron???s Pasatru wins FDA approval in ultra-rare???stone man disease???
24+ min ago (211+ words) Pasatru demonstrated strong efficacy in a Phase III trial, helping patients reduce lesions and flare-ups. Regeneron has won US Food and Drug Administration (FDA) approval for Pasatru (garetosmab-grts) in a rare connective tissue disorder, placing it in direct competition with…...
FDA grants accelerated approval to Ultragenyx's Genglycos gene therapy
1+ hour, 29+ min ago (432+ words) The FDA granted the approval for Genglycos based on a 48-week Phase III study involving 46 participants. Ultragenyx Pharmaceutical has received accelerated approval from the US Food and Drug Administration (FDA) for its gene therapy, Genglycos (pariglasgene brecaparvovec-opnr), to treat glycogen…...
SandboxAQ introduces AQPotency for virtual drug screening
2+ hour, 18+ min ago (348+ words) AQPotency enables drug discovery teams to assess and rank candidate molecules’ likely interactions with specific disease targets. US-based SandboxAQ has introduced AQPotency, a Large Quantitative Model (LQM) designed to virtually screen and predict the potential of drug candidates without the…...
BioMarin spends up to $490m for Alesta???s bone disease candidate
21+ hour, 14+ min ago (463+ words) The deal provides BioMarin with a potential rival to AstraZeneca’s blockbuster Strensiq in hypophosphatasia. BioMarin Pharmaceutical has outlaid $490m to acquire rare disease drug developer Alesta Therapeutics, though it plans to keep only one asset from the biotech’s pipeline. BioMarin has…...
Andelyn Biosciences to develop GM2 gangliosidosis therapy
1+ day, 2+ hour ago (302+ words) Andelyn Biosciences is set to develop and manufacture a gene therapy known as AAV9-GM2, for Queen’s University to treat GM2 gangliosidoses, including Tay-Sachs and Sandhoff diseases. The partnership aims to progress this gene therapy using Andelyn’s AAV Curator Platform. GM2 gangliosidosis is a…...
Reformed pharmaceutical regulation across India???s drug landscape
1+ day, 20+ hour ago (69+ words) Reformed pharmaceutical regulation across India’s drug landscape pharmaceutical-technology.com Unlock FREE Access to Premium Content Discover exclusive forecasts, analyst insights, and in-depth pharmaceutical industry analysis spanning drug development, manufacturing, regulation, and global healthcare trends. With a free Pharmaceutical Technology profile,…...
Updated UK guidance for finerenone introduces new treatment for HF patients
2+ day, 40+ min ago (73+ words) pharmaceutical-technology.com Unlock FREE Access to Premium Content Discover exclusive forecasts, analyst insights, and in-depth pharmaceutical industry analysis spanning drug development, manufacturing, regulation, and global healthcare trends. With a free Pharmaceutical Technology profile, you can: - View premium forecasts and data-driven…...
Faeth’s PIKTOR plus paclitaxel combo gains FDA fast track status
2+ day, 1+ hour ago (277+ words) The designation applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor. Faeth Therapeutics has received the US Food and Drug Administration’s (FDA) fast track designation for the sapanisertib and serabelisib (PIKTOR) with paclitaxel combination to…...
EMA validates Pfizer and Valneva’s Lyme disease vaccine
3+ day, 1+ hour ago (323+ words) The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial. The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405. With…...
Immunology specialist Khartis Therapeutics emerges from stealth with $95m
6+ day, 1+ hour ago (218+ words) Khartis was co-founded two years ago by the team at XinThera, a biotech acquired by Gilead. Armed with $95m in funding and a former Pfizer drug discovery specialist, Khartis Therapeutics has emerged with the aim of bringing a new treatment for…...