Moderna

The Outsourcing In Clinical Trials New England Conference, held on 23–24 October in Boston, will address biotech layoffs, regulatory changes, and AI advancements in drug development. Panels will discuss layoffs, economic shifts, FDA measures, and AI's impact on clinical trials, including patient recruitment and drug discovery.

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.

WHO declared mpox a PHEIC in 2024, emphasizing the need for more vaccines, especially in Africa. Ongoing trials include Moderna's mRNA-1769 and BioNTech's BNT166a, both in Phase I/II. Bavarian Nordic's Jynneos is also being tested in pediatric patients in the Democratic Republic of Congo.

Precision medicine uses genetic, environmental, and lifestyle data to tailor treatments, with AI, CRISPR-Cas9, and mRNA as key trends. AI accelerates genomic analysis and drug discovery, CRISPR-Cas9 offers precise gene editing, and mRNA vaccines expand beyond COVID-19, driving personalized healthcare.

Lack of funding and understanding of long COVID's mechanisms hinder drug development, frustrating patients and researchers. Despite initial positive results with Ampligen, Aim ImmunoTech faced funding challenges. The NIH's RECOVER initiative focuses on observational studies rather than new compounds, and private investors avoid long COVID due to perceived risk. Small biotech companies struggle to sustain research efforts, with some shifting focus or shutting down. Public-private partnerships and increased federal funding are suggested as solutions to advance long COVID treatment research.

AllClinicalTrials.com unifies US clinical trial data, simplifying access for patients and researchers. Features include a pre-screener survey, advanced search filters, and real-time notifications for new trials. Successfully supported Moderna's Phase 3 COVID-19 vaccine trial recruitment.