The U.S. FDA has approved Eicos Sciences Inc.’s Aurlumyn (iloprost) for treating severe frostbite. The injectable vasodilator, which opens blood vessels and stops blood from clotting, is now approved for adults to reduce finger or toe amputations and is, according to the FDA, the first-ever treatment option for severe frostbite. The drug, also referred to as ES-2001, had the FDA’s priority review and orphan drug designations for treating severe frostbite. Read More
The demand for semaglutide, a GLP-1 drug, and other popular prescription weight-loss drugs is adding to the U.S. FDA’s regulatory load as more and more companies are offering unapproved knockoffs of the products directly to consumers. The FDA posted two warning letters Feb. 13 – to Miami-based US Chem Labs and a New-York company, Synthetix Inc. doing business as Helix Chemical Supply – citing the companies for misbranding unapproved semaglutide and tirzepatide, also a GLP-1 drug, by marketing them on the Internet, along with claims about their therapeutic benefits. Read More
When founders of Latigo Biotherapeutics Inc. first set out a few years ago to establish a biopharma firm focused in the area of pain, the plan had been to get a head start by in-licensing promising assets in the space. But that proved easier said than done. “With the exception of very early chemical matter” from the Lieber Institute for Brain Development, “we really couldn’t find anything else of quality to bring in, which I think is a testament to how little pain research and investment was ongoing in pharma and academia,” said Sean Harper, co-founding managing director at Westlake Village Biopartners, which founded Latigo in 2020 and led the firm’s $135 million series A round. Read More
The U.S. Court of Appeals for the Sixth Circuit made it clear that it’s the court’s purview, not a jury’s, to determine whether an expert’s testimony is “relevant and reliable” when it comes to issues such as causation. It gave that lesson Feb. 13 when it affirmed a lower court’s dismissal of multi-district litigation in which the plaintiffs claimed that Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin hydrochloride), developed by Astrazeneca plc and Bristol Myers Squibb Co., caused their heart failure. Read More
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke. Read More
After Lianbio Co. Ltd. turned away a $465 million acquisition offer from Concentra Biosciences LLC, the China and U.S.-based biotech announced it was selling off its assets and shutting down the company. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Artax, Eyebiotech, G1, Kalvista, Medicenna, Ocular, Olix, Otsuka, Protagenic, Puma, Transposon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brii, Concentra, Elsie, Erasca, GSK, Novartis, Numab, Ono, Shattuck, Theseus, Tilt, VBI. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicanna, Biogen, Calcimedica, Candel, Crispr, Edgewise, Krystal, Lineage, Lykos, Rocket, Trawsfynydd. Read More
