GlaxoSmithKline

Study on MM treatment decision-making highlights QoL, duration of response, and side effects as top attributes for patients, care partners, and physicians. Differences in preferences and trade-offs underscore the importance of shared decision-making (SDM) to align treatment plans with patient values and improve outcomes.

Supernus Pharmaceuticals' SPN-820 showed rapid and substantial effects in a Phase IIa trial for major depressive disorder, with a clinically meaningful improvement on the HAM-D6 scale and a significant reduction in suicidal ideation. SPN-820 is designed as a rapid-acting treatment, contrasting with the slower effects of SSRIs, and is well-tolerated with common AEs like headache and nausea. A Phase IIb study is ongoing, with results expected in H1 2025.

FDA grants Priority Review to GSK’s gepotidacin NDA for uncomplicated uUTIs in females and adolescents, supported by Phase III EAGLE-2 and EAGLE-3 trials showing non-inferiority to nitrofurantoin. Gepotidacin demonstrated therapeutic success rates of 58.5% and 50.6% in EAGLE-3 and EAGLE-2, respectively, compared to 43.6% and 47% for nitrofurantoin. Safety and tolerability consistent with previous trials, with common AEs being gastrointestinal.

GSK's gepotidacin, an oral antibiotic for uncomplicated urinary tract infections, has been accepted for priority review by the FDA, with a decision expected by 26 March 2025. The drug targets drug-resistant bacteria and is supported by positive EAGLE-2 and EAGLE-3 trial results.

Early-phase oncology trials now focus on efficacy with novel immunotherapeutic agents like bispecific antibodies and CAR T-cell therapy, necessitating refined trial designs, patient selection strategies, pharmacodynamics markers, and adverse event management. Submissions on exceptional toxicities, progress reviews, and early-stage clinical trials are welcomed.

Wave Life Sciences' WVE-006, an RNA editing oligonucleotide for alpha-1 antitrypsin deficiency (AATD), showed successful RNA editing in 2 Pi*ZZ AATD patients, producing wild-type M-AAT protein and increasing neutrophil elastase inhibition. No serious adverse events were reported, and the therapy is considered well-tolerated. This marks the first clinical demonstration of therapeutic RNA editing in humans.

GSK and ViiV's Apretude shows over 99% effectiveness in preventing HIV in real-world studies, with high adherence and no HIV diagnoses in Trio Health cohort. Apretude, the first long-acting PrEP, aims to extend dosing intervals beyond two months, while Gilead's lenacapavir shows 100% efficacy in women and 96% in diverse populations, targeting a twice-yearly injection.

DIA's Canada Annual Meeting on Nov. 14-15 will discuss precision regulation, AI integration, and Canada's clinical trial advancements, with Health Canada modernizing frameworks for innovations like AI and personalized medicine, and collaborating with international agencies like Brazil's ANVISA.

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