Moderna

Merck and Moderna initiate INTerpath-009 Phase 3 trial evaluating V940 (mRNA-4157) with KEYTRUDA for adjuvant treatment in resectable Stage II, IIIA, or IIIB NSCLC patients not achieving pCR after neoadjuvant therapy. Recruitment has begun in Canada.

The 'golden age' of medicine sees breakthroughs in mRNA, ADCs, and microbiome therapies, with Casgevy's approval marking a CRISPR milestone. Oncology and immunology dominate drug sales, while obesity, Alzheimer’s, and CVD treatments gain momentum. Precision medicine and cost optimization are priorities, leveraging AI, blockchain, and IoMT. Health system reforms in the U.S. and EU introduce stricter pricing regulations, challenging drug manufacturers.

Pharma companies like Merck and Moderna spend significantly more on R&D than medtech firms, but higher spending doesn’t always correlate with more innovation output. Medtronic, with 8.45% R&D intensity, generated 443 patents and 305 publications in 2023, while Moderna, spending 70.75% of revenue on R&D, produced only 27 patents and 245 publications. Medtech firms consistently show higher patent output per R&D dollar invested.

GSK's RSV vaccine Arexvy sales dropped 72% in Q3 due to narrower US recommendations and COVID-19 vaccination prioritization. Pfizer's Abrysvo sales declined only 5%, suggesting Pfizer's ascendency in the RSV vaccine market. GSK's overall vaccine sales fell 15%, leading to a revised forecast of low-single-digit percentage gains. Despite this, GSK's overall revenues increased 2% to $8 billion, supported by HIV drugs and specialty medicines.

ChatGPT, OpenAI's AI chatbot, has grown rapidly since 2022, used by 92% of Fortune 500 companies. OpenAI's partnership with Apple for Apple Intelligence boosts its AI race position. GPT-4o, with voice and vision capabilities, became the default free model but faced issues like mimicking Scarlett Johansson's voice. OpenAI faces internal drama, including co-founder Ilya Sutskever's exit, and lawsuits for copyright infringement. Recent updates include AI chip development, search history features, and integration with iOS 18.1.

Moderna and MSD initiated a Phase III trial to evaluate mRNA-4157 (V940) with Keytruda for non-small cell lung cancer, targeting patients who did not achieve a complete response after initial treatment.

Bavarian Nordic plans to expand MVA-BN mpox/smallpox vaccine approval to children aged 2-11, initiating a Phase II trial. The study, partially funded by CEPI, aims to compare safety and immunogenicity between children and adults. MVA-BN is marketed as Jynneos in the US and Imvanex in Europe, with recent label expansions by EMA and GAVI agreements.

Merck and Moderna initiate INTerpath-009, a phase 3 trial evaluating mRNA-4157 (V940) combined with Keytruda for adjuvant treatment in resectable Stage II, IIIA, IIIB (N2) NSCLC patients who did not achieve pCR after neoadjuvant Keytruda plus platinum-based chemotherapy. The trial aims to improve disease-free survival and overall survival rates for lung cancer patients.

Moderna officers and directors face shareholder derivative allegations for overstating the effectiveness of the company's RSV vaccine candidate during regulatory approval.