Factor XIa inhibitors milvexian and asundexian, hailed as the next-generation class of anticoagulants, earned mixed reviews on phase II data presented during the European Society of Cardiology Congress 2022. However, developers Bristol Myers Squibb Co./Janssen Pharmaceutical Co. and Bayer AG, respectively, are moving into late-stage testing, citing clear mechanisms of action that put the FXIa drugs at least on par with approved factor Xa drugs in terms of efficacy while offering potentially better safety profiles that could give physicians an option for patients with stroke or atrial fibrillation who are currently undertreated with anticoagulants due to bleeding risks.

Skin deep: Sirnaomics posts 100% complete responses in basal cell carcinoma phase II study

Sirnaomics Ltd. went five for five in its study of treating cutaneous basal cell carcinoma. Five of five patients in a cohort of the open-label, dose-escalation phase II study of STP-705, composed of two sIRNA oligonucleotides targeting transforming growth factor beta 1 and cyclooxygenase-2, had a 100% complete response. The cohort received a 180-mg dose. There were no adverse events and no significant cutaneous skin reactions. A full report on the data is expected in the first quarter of 2023. In January, Sirnaomics became the first RNA therapeutics company to list on the Hong Kong Stock Exchange with a $64 million IPO. Shares (HKEX:2277) ticked slightly higher Aug. 29, closing at HK$69.40 (US$8.84) each.

‘Skinny labels’ at forefront of possible Supreme Court biopharma cases

If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC (GSK), it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that's still an 'if.' Whether the patent infringement case, involving a so-called 'skinny label,' makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts. According to the way Teva and several amicus briefs interpreted a split Federal Circuit decision, the appellate court held that Teva’s FDA-approved generic label carving out a patented use for GSK’s heart drug, Coreg (carvedilol), induced infringement of viable patents. If that's the case and the appellate decision is allowed to stand, “no skinny label generic is safe,” the dissenting Federal Circuit judge said. But GSK poses the question differently: Is an approved skinny label enough to protect generic sponsors from infringement when there’s a “strong record [of] evidence of intent and inducing conduct”?

‘What’s old is new again’ with tweaks to drugs, patients, trials

Gate Neurosciences Inc., of Carmel, Ind., was founded in 2019. But the company officially launched last week with two clinical-stage assets and a bold goal: to develop better drugs for CNS disorders and identify better-suited patients for those drugs. The company’s first molecular target is the NMDA receptor. Gate has acquired the rights to two NMDA receptor modulators, zelquistinel and apimostinel, that are in phase II trials for the treatment of major depressive disorder and is pursuing the development of EEG biomarkers capable of predicting who will respond to NMDA-targeted drugs.

Antimicrobial evybactin selectively targets Mycobacterium tuberculosis

Scientists have discovered a new antibiotic called evybactin that is able to selectively target Mycobacterium tuberculosis, the bacteria that causes tuberculosis lung infections.

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89bio, Acorda, Aeterna Zentaris, Alvotech, Amarin, Asieris, Athos, Biocryst, Biomea, Biontech, Fibrogen, Galecto, Ideaya, Inhibikase, Nordic Nanovector, Novavax, ONK, Organicell, Pfizer, Sanyou, Timber, Vilya