The U.S. FDA has approved Actelion Pharmaceuticals US Inc.’s Aurlumyn (iloprost) for treating severe frostbite. The vasodilator, which opens blood vessels and stops blood from clotting, is 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 had the FDA’s priority review and orphan drug designations for treating severe frostbite. Johnson & Johnson acquired Allschwil, Switzerland-based Actelion for about $30 billion in cash in 2017, making Actelion part of J&J’s Janssen Pharmaceutical Cos. Actelion bought Cotherix Inc. for $420 million in 2006, giving Actelion a second marketed product in pulmonary arterial hypertension. That was Ventavis (iloprost), an inhaled, synthetic prostacyclin analogue that gained FDA approval in late 2004.

US FDA slaps companies for unapproved weight-loss drugs

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 warning letters this week to two companies for marketing unapproved semaglutide and tirzepatide, also a GLP-1 drug, on their websites, along with therapeutic benefit claims – even though both companies have labeled the products for “research use only” and “not for human consumption.”

Latigo emerges with $135M for non-opioid pain program

Though it was founded in 2020, Latigo Biotherapeutics Inc. has just emerged from stealth, disclosing a $135 million series A financing led by Westlake Village Biopartners, and plans to advance an early stage candidate targeting acute and chronic pain. Its lead program, LTG-001, is an oral, selective inhibitor of NaV1.8, a sodium channel identified for its role in pain signaling. Funds from the series A will be used to advance that program, currently in phase I testing, as well as to further develop a discovery-stage pipeline of small molecules against other genetically identified targets.

Appeals court: Diabetes drug causation claims don’t stand up

The U.S. Court of Appeals for the Sixth Circuit delivered good news this week to Astrazeneca plc and Bristol Myers Squibb Co. when it affirmed a lower court’s dismissal of multi-district litigation in which plaintiffs claimed that diabetes drugs containing saxagliptin caused their heart failure. The summary judgment on behalf of the pharma companies stemmed from the lower court’s exclusion of the plaintiff’s only causation expert. On appeal, the plaintiffs argued that the jury, not the judge, “must evaluate and weigh conflicting expert testimony.” Not so, the Sixth Circuit said, adding that “district courts may allow juries to evaluate and weigh only relevant and reliable expert testimony.” In this case, the appellate court found that the plaintiffs’ expert cherry-picked the data in a way that undermined the scientific method and that serves as “a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”

Phase III data positive for GNT's neuroprotective stroke drug 

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. Results from the phase III Rodin trial presented at the International Stroke Conference 2024 showed timely treatment with both revascularization and nelonemdaz significantly improved the rate of patients reaching a modified Rankin scale of 0 by 4.93-fold compared to placebo. However, nelonemdaz seemingly failed to outdo placebo for the secondary endpoint of functional independence. The latest findings justify a second, larger multinational phase III study of nelonemdaz to further confirm drug efficacy, the company said.

Lianbio shuttering operations, after rejecting Concentra 

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. That news likely won’t come as a surprise to top executives who resigned after shareholders turned down the Concentra offer. Lianbio founder and CEO Yizhe Wang and Chief Financial Officer Yi Larson both resigned at the time, with Lianbio shelling out $2.4 million in severance pay to Larson and $1.52 million to Wang. In the Feb. 14 announcement, Lianbio said it would “wind down” its operations, sell off remaining pipeline assets, delist its American depositary shares from Nasdaq, and reduce its workforce by 50% in the first quarter of 2024, with additional reductions following the transition of assets to partners.

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