Moderna

The FDA has lifted the clinical hold on Novavax's COVID-19 and influenza combination vaccine trials, allowing Phase 3 testing to resume after addressing concerns. The hold was due to a serious adverse event initially classified as motor neuropathy, later determined to be ALS, unrelated to the vaccine. Novavax aims to capitalize on a protein-based alternative to mRNA vaccines, despite market challenges.

Moderna's mRNA RSV vaccine mRESVIA approved by Health Canada for individuals aged 60 and over, marking the first mRNA RSV vaccine in Canada. The approval is based on the ConquerRSV Phase III study showing 83.7% efficacy in preventing RSV lower respiratory tract disease. mRESVIA is expected to be available in Canada in early 2025 and is currently the only vaccine in a single-dose prefilled syringe format.

Ruchika Sharma, B.Com from Delhi University and M.Com postgraduate, joined Medical Dialogue in 2019 as a Business Section Correspondent, covering Pharmaceutical updates, Policy, Insurance, Business Healthcare, Medical News, Pharma News, Healthcare, and Investment.

Arcturus Therapeutics reported a net loss of $6.9 million in Q3 2024 but remains optimistic with a cash runway into Q1 2027. The company launched its first commercial product, KOSTAIVE, in Japan, receiving a $25 million milestone payment. Arcturus plans to file a BLA for KOSTAIVE in the U.S. in H1 2025 and anticipates interim Phase 2 data for ARCT-032 and ARCT-810 in early 2025. The company's cash reserves are $294.1 million, and it secured $462.1 million in upfront payments and milestones from CSL.

Moderna announces Health Canada approval of mRESVIA, an mRNA vaccine for preventing RSV-related lower respiratory tract disease in adults 60 and older.

The Asia Pacific mRNA therapeutics contract development & manufacturing market is rapidly growing due to increased R&D investments, disease prevalence, and technological advancements. Infectious diseases dominate the market, with mRNA technology expected to be a 'game-changer' in vaccine manufacturing. Key markets include Japan, Singapore, Australia, Indonesia, China, South Korea, and India. Horizon Databook offers comprehensive data, insights, and customizable reports to aid informed decision-making and strategic advantage.

Recent RSV vaccine developments include FDA approvals for Moderna's mRNA-1345, GSK's Arexvy, and Pfizer's Abrysvo, with expanded age groups. CDC's ACIP updated recommendations for RSV vaccination in adults. Maternal RSV vaccines showed no increased risk of preterm birth but had a modest risk of maternal hypertensive disorders. Nirsevimab and clesrovimab demonstrated effectiveness in preventing RSV hospitalizations in infants. Reports of Guillain-Barré syndrome following RSV vaccination were rare but higher than expected, though benefits of vaccination are deemed to outweigh the risk.

Robert F. Kennedy Jr. may lead health policies under Trump, focusing on 'clean up corruption,' returning agencies to 'gold standard' of science, and 'Make America Healthy Again.' Kennedy supports capping drug prices, opposes vaccine mandates, and aims to shift NIH funding towards preventive health. He also seeks to reform drug ads and address obesity and chronic disease, though his anti-vaccine stance and criticism of pharma profit from chronic illness have raised concerns.

Moderna's Q3 COVID-19 vaccine sales exceeded expectations at $1.8B, but full-year guidance remains unchanged, suggesting a potential decline in Q4. mResvia, Moderna's RSV vaccine, generated $10M in revenue, significantly below projections. Moderna plans to cut R&D expenses by 20% and prioritize investments in new vaccines and rare disease drugs.

Arbutus Biopharma Corp reported $131M in cash, cash equivalents, and investments, with a cash burn of $63-67M expected for 2024, funding operations into Q4 2026. Phase two trials showed significant surface antigen loss in chronic hepatitis B patients. Litigation with Moderna and Pfizer Biontech over LNP intellectual property is ongoing, with trial dates set for 2025.