The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS). The news is “bittersweet” said Hilary Evans-Newton, chief executive of the research charity Alzheimer’s Research UK. “It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s. … However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs,” she said.

Innovent wins nod for China’s first KRAS G12C lung cancer drug

The National Medical Products Administration (NMPA) has approved Innovent Biologics Inc.’s Dupert (fulzerasib) as the first KRAS G12C inhibitor in China to treat select patients with non-small-cell lung cancer (NSCLC). Shanghai-based Innovent said Aug. 21 that fulzerasib was domestically approved as a novel, oral second-line therapy to treat adult patients with KRAS G12C-mutated NSCLC who have received at least one systemic therapy. Hui Zhou, senior vice president of Innovent remarked that Dupert’s approval is “the beginning of a new era in targeted therapy for KRAS mutations” in China, considering the patient population historically had limited treatment options and minimal benefits from traditional chemotherapy.

Borealis from Novartis is born from the remains of Chinook

Rising from the shadow of Chinook Therapeutics Inc., Novartis AG and Versant Ventures have launched Borealis Biosciences to develop RNA therapies for treating kidney disease. Novartis said it moved some employees and Chinook’s Vancouver, British Columbia, site to newly created Borealis. A $150 million series A financing from Novartis is part of the deal, as is the option Novartis has to acquire two future development-ready programs from Borealis. Through the $3.5 billion acquisition of Versant-created Chinook in June 2023, Novartis bolstered its renal diseases pipeline by gaining access to atrasentan, an oral endothelin A receptor antagonist, and zigakibart, a subcutaneously administered anti-APRIL antibody. Both are in clinical trials for treating immunoglobulin A nephropathy.

Vandria’s series A funds spur development of mitophagy inducer

After sparking further interest from investors after the close of its series A, Vandria SA has extended the round and now has the means to advance its lead mitophagy inducer program as far as phase Ib/IIa development in the treatment of mild cognitive impairment. In preclinical research, VNA-318, an orally available small molecule, was seen to have a dual mode of action, prompting an immediate improvement in memory and having a long term disease-modifying effect. Before treatment, only 30% of elderly rodents passed a memory test; after receiving VNA-318 70% did so. “It’s very exciting data,” Klaus Dugi, Vandria CEO, told BioWorld.

A Bridgebio not far: PDUFA looms for acoramidis, firm keeps busy

As Bridgebio Pharma Inc. awaits word from the U.S. FDA regarding the small-molecule transthyretin (TTR) stabilizer acoramidis for TTR-mediated amyloidosis cardiomyopathy, its spin out of a new firm called Gondolabio LLC continues to advance work in rare diseases.

Also in the news

Aadi, Aditxt, Appili, Axsome, Bio-Path, Bioxodes, Bristol Myers Squibb, Dr. Reddy’s, Innovo, Kainomyx, Lexicon, Pharmazz, Regeneron, Retention, Reviva, Sandoz, Scinai, Sun, Timber, Vaxil