Moderna

Moderna, a biotech company specializing in mRNA technology, developed one of the first COVID-19 vaccines and researches treatments for infectious diseases, cancer, and rare genetic disorders. Founded in 2010, it became publicly traded in 2018 and has since expanded its mRNA-based vaccine research to include RSV, HIV, and Zika fever, among others.

FDA experts call for more data on RSV vaccine safety in infants after Moderna trial pause. Panel seeks additional information before moving forward, emphasizing need for better understanding of immune response in different age groups.

The global medical writing market is projected to grow from US$3.44 billion in 2021 to US$9.09 billion by 2031, at a CAGR of 10.2%. This growth is driven by the expansion of pharmaceutical, biotechnology, and medical device industries, increased clinical trials, and stricter regulatory requirements. Key players include Cactus Communications, Certara, Covance, and others.

ChatGPT, launched in Nov 2022, has grown to 300M weekly users. In 2024, OpenAI partnered with Apple, released GPT-4o with voice/vision, and launched Sora video generator. OpenAI faced exec departures, lawsuits, and Musk's injunction. Product updates include real-time vision in Advanced Voice Mode, Canvas for writing/coding, and ChatGPT Pro at $200/month. OpenAI also announced '12 Days of OpenAI' with new product reveals.

COVID-19 treatment companies focus on vaccines, antivirals, monoclonal antibodies, and supportive care. Vaccines like Pfizer-BioNTech and Moderna reduce severe cases, while antivirals like Remdesivir and Paxlovid limit viral replication. Monoclonal antibodies like Bamlanivimab offer early intervention. Supportive care remains crucial. Market growth is driven by COVID-19 spread, new variants, and increased demand for effective therapies. Government investments and rapid vaccine advancements accelerate treatment availability. The global pulmonary drug delivery systems market is projected to reach USD 97.8 billion by 2033.

FDA halted RSV vaccine clinical studies in infants due to safety concerns from a Moderna trial, reporting severe RSV infections in vaccinated infants. Moderna paused enrollment, and the FDA placed a clinical hold on the trial. The FDA's VRBPAC will discuss safety data and implications for future pediatric RSV vaccine development.

FDA detected severe side effects in Moderna's mRNA-1345 and mRNA-1365 RSV vaccine candidates for infants, with blunted responses to prophylactic antibody Beyfortus. VRBPAC will discuss safety findings, implications for pediatric development, and potential interactions between RSV prophylactic antibodies and vaccines. mRNA-1345 is approved for adults aged 60+ and continues in high-risk adults and pediatric populations. mRNA-1365, a combination vaccine for RSV and human metapneumovirus, is in Phase I. Moderna paused mRNA-1365 study due to severe RSV LRTI cases.

2024 saw significant advancements in skin cancer treatment, including FDA approvals for lifileucel and IBI363, new clinical guidelines for nonmelanoma skin cancer, an updated PDUFA date for subcutaneous nivolumab, and 3-year data for mRNA-4157 combined with pembrolizumab.

Sanofi's two combination vaccine candidates, NCT06695117 and NCT06695130, received Fast Track designation from the FDA for preventing influenza and COVID-19 in people aged 50+. These candidates combine Sanofi's Fluzone High-Dose or Flublok with Novavax's NVXC19 vaccine. Sanofi and Novavax have a deal for co-marketing NVXC19 from 2025, with Sanofi having sole rights to develop and market the combination with its influenza vaccines. Novavax's NVXC19 shows better tolerability and high efficacy. Sanofi's Vaccines unit has strong sales growth, expecting over €10 billion in annual net sales by 2030.

Herpes simplex 1 and 2, which cause cold sores, remain incurable and can reactivate due to stress. Antiviral medications can manage outbreaks but not eliminate the virus. Researchers are exploring vaccines and gene therapy for prevention and treatment, with some promising early-stage trials.