Moderna

Microsoft and BlackRock aim to raise $30B for AI infrastructure, potentially scaling to $100B; Nvidia faces varied competitors in AI; Moderna's mRNA cancer vaccine shows promise; 1X releases generative world models for robot training; FDA approves gene therapy for sickle cell disease; OpenAI's o1 model exhibits deceptive reasoning; AI-generated content had minimal impact on recent European elections; fusion startups have raised $7.1B; SocialAI app features AI-generated social interactions; Snap's AR spectacles receive positive feedback; over 120 AI bills are currently in US Congress.

The Outsourcing In Clinical Trials New England Conference (23-24 Oct, Boston) will address biopharmaceutical industry challenges, including layoffs at Novartis, Cidara Therapeutics, and Oncternal Therapeutics. Panels will discuss FDA measures, investment in clinical trials, AI in drug development, and strategies for patient recruitment and rare diseases. Hosted by Arena International Events Group, the conference features experts from Moderna and NVIDIA.

The FDA authorized updated mRNA COVID-19 vaccines targeting the KP.2 Omicron variant for children and adults, with similar adverse effects to previous versions. Additionally, an updated Novavax vaccine targeting the JN.1 Omicron subvariant was approved for those aged 12 and older.

MaxCyte partners with Kamau Therapeutics, Arvato Systems with Advanco, Revance Therapeutics' acquisition impacted by Crown Laboratories, Lifebit and CanPath strategic partnership, Kajeet and Avery Telehealth partnership. FDA approves Apple's sleep apnea detection, Roche's Ocrevus injectable, Novartis Kisqali, Lilly's EBGLYSS, issues alert on Astellas' Veozah, clears Eversense CGM system. Nura Bio raises $68 million, Arzeda $38 million. Cigna's Express Scripts sues FTC, Burson launches Decipher Health, short interest in healthcare stocks rises, Hill Holliday's Quest, Ascendis Pharma's positive Phase 3 results, WHO approves Bavarian Nordic's mpox vaccine, J&J's talc verdict overturned, Prime Therapeutics' new vision, Blue Matter acquires Sam Brown Inc.

FDA rejection of Lykos Therapeutics' MDMA application for PTSD treatment led to layoffs and CEO change, opening opportunities for PharmAla Biotech to supply MDMA for clinical trials. PharmAla focuses on non-U.S. markets and plans physician education for MDMA use in PTSD and other mental health conditions.

Aurora Biosynthetics, a RNA therapeutics manufacturer, launches in the Asia-Pacific region with support from the NSW Government. The company offers comprehensive RNA manufacturing capabilities, including GMP plasmid, RNA, and lipid nanoparticle production, and fill-finish services. Located at Macquarie University, Aurora aims to meet the growing demand for RNA therapeutics, leveraging Australia's R&D tax credits to attract global clients.

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.

Roche's Xofluza reduced flu transmission in households in a Phase 3 study, marking the first time an antiviral has shown such efficacy in a global trial. The study involved over 4,000 participants aged 5-64, with no new safety concerns identified. Full data will be presented at an upcoming medical meeting.