The biotech industry's rapid response to COVID-19, a pivot of global scope, is driving a broad array of approaches to tackling the infection. On Monday, the first day of BIO's virtual convention, the trade group gathered some of the effort's leading voices to take stock of how those efforts are shaping up. It put a spotlight on work underway at Athersys Inc., Regeneron Inc., SAB Biotherapeutics Inc., Takeda Pharmaceutical Co. Ltd. and Vir Biotechnology Inc. Read More
When BIO 2019 closed its doors in Philadelphia last June, none of the delegates of the industry’s largest event would have predicted that the next meeting, scheduled for San Diego, would be canceled and the event would be transformed into a virtual version. In just a few months, the COVID-19 pandemic has decimated our normal way of life and, until effective therapeutics and vaccines become available, how we conduct the business of biotechnology will remain radically different. This will be one of the many themes explored during BIO Digital Week that kicked off today. Read More
DUBLIN – Alnylam Pharmaceuticals Inc. is on track to secure its third FDA approval in successive years, as its siRNA drug, lumasiran, hit all its marks in a phase III trial in patients with primary hyperoxaluria type 1 (PH1). The drug is already undergoing regulatory review and has a Dec. 3 PDUFA action date. It is undergoing accelerated assessment in Europe as well. Read More
In a big day of setting up IPOs for launch, the charge is being led by Royalty Pharma, a buyer of biopharmaceutical royalties and an industry funder, which is aiming at a $2 billion offering. That massive number is more than half of the total biotech offerings brought in through May. Read More
PERTH, Australia – Aussie biotech CSL Ltd. and the University of Queensland (UQ) have entered a development agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate development, manufacture and distribution of a COVID-19 vaccine candidate developed by the University of Queensland. Read More
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA). Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Arch, Cassi, Cytodyn, Enochian, Heat, Helsinn, Insmed, Kiniksa, Lupin, Sound, Taiho. Read More
