Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

The last word starts right now with Ally Veli. Uh once again in for Lawrence. Hey Ally. Uh Jen, I I often jokingly say that your your work keeps me from doing mine as I prep for the show, but uh your show was something else tonight. U I hope everybody saw it. Uh I will be playing some of your monologue in this show just to to remind people how they need to think about these things because you and I in different roles have have seen too much of this and and and been involved in too many of them. And you're r ...

Pharmaceutical Industry Trends & Future Directions - The pharmaceutical field is dynamic, with innovations like hydrogels for prolonged drug effects and biodegradable implants for long-term drug delivery [20] - Micro needles, similar to nicotine patches, offer a less invasive drug delivery method [21] - Personalized medicine, driven by AI, is an upcoming trend, tailoring therapies based on individual genetic codes [21] - Nanoparticles are being explored for targeted cancer treatment, aiming for better therapeuticity and reduced harm to normal cells [19] - Lipid nanoparticles are crucial for mRNA vaccines, delivering RNA to help the body battle diseases [17] Drug Development & Treatment Advancements - The development of anti-retroviral therapy (ART) for the first pandemic (likely referring to HIV/AIDS) took 15 years [16] - The development of mRNA vaccines for the COVID-19 pandemic took less than a year [16] - Nanoparticles can be functionalized in various shapes to reach inaccessible parts of the body, potentially revolutionizing medicine [18] Personal Journey & Passion in Pharmaceutics - Passion is defined as being fascinated by something to the point of losing track of time [3] - The speaker's initial plan was not pharmaceutics, but a desire to help people and save lives, influenced by family experiences with breast cancer, led to this path [5][6] - The speaker shifted from wanting to be in corporate to wanting to be in the lab, focusing on the scientific aspects of drug creation [8] - Pursuing a master's in the US was chosen due to better funding and infrastructure compared to India [9]

Funding & Policy Changes - HHS (美国卫生与公众服务部) 决定 mRNA 技术对呼吸道病毒的风险大于收益，因此 BARTA (生物医学高级研究与发展管理局) 已开始终止总额近 5 亿美元（约合 5 亿美金）的 22 份合同 [2] - 美国卫生部长 Robert F Kennedy Jr 宣布撤回 5 亿美元（约合 5 亿美金）的联邦资金，这些资金原本用于 mRNA 疫苗的研究和开发 [1] - Kennedy 采取了一系列措施，包括解雇数千名公共卫生部门的员工，在 HHS (美国卫生与公众服务部) 安排反疫苗盟友，削减州和地方卫生部门数十亿美元的资金，取消数十亿美元的疫苗研究资金，解散联邦疫苗咨询小组，并退出一项拯救了数百万儿童生命的全球疫苗计划 [6] Scientific & Public Health Concerns - 科学家和医生谴责了这一举动，指出 Kennedy 错误地认为 mRNA 疫苗不能预防呼吸道疾病 [2] - 公共卫生专家警告说，现在停止资助将使美国在未来面临更大的健康威胁 [4] - mRNA 疫苗在疫情期间拯救了数百万人的生命，降低了 COVID 的严重程度，并防止了住院 [3] - Kennedy 散布关于 COVID 疫苗的谎言，声称它们无效，会改变 DNA，导致不孕，并导致广泛的伤害和死亡 [5] Organizational Impact - Kennedy 成立的美国最大的反疫苗组织 Children's Health Defense 正在庆祝 Kennedy 的最新举动 [7] - HHS (美国卫生与公众服务部) 内部的科学家和研究人员对 Kennedy 的最新举动感到震惊 [6]

The health department is pulling the plug on a half a billion dollars in funding specifically for mRNA vaccine development. Health Secretary Robert F. Kennedy Jr.. calling the technology behind current COVID and RSV vaccines quote ineffective. mRNA vaccines don't perform well against viruses that infect the upper respiratory tract. mRNA only codes for a small part of the viral proteins, usually a single antigen.one mutation and the vaccine becomes ineffective. Scientists and vaccine experts are now coming o ...

Vaccine Development - RFK Jr 取消了在美国的 5 亿美金 mRNA 疫苗开发项目 [1]

Core Insights - Moderna's experimental mRNA-based flu vaccine has shown a stronger immune response compared to the currently available vaccine in late-stage trials, paving the way for further development of both the flu vaccine and a combination flu and Covid jab [1][3]. Company Developments - In May, Moderna voluntarily withdrew its application for the combination vaccine targeting Covid-19 and influenza, planning to resubmit it with efficacy data from the phase three trial of its standalone flu vaccine [2]. - The company intends to resubmit the application for the combination vaccine and seek approval for its standalone flu shot later this year, with expectations for regulatory approvals for both products next year [3]. Market Position - Moderna is currently a frontrunner against competitors Pfizer and Novavax in the race to market a combination vaccine, with the potential for significant revenue from the multi-billion-dollar markets of Covid, flu, and respiratory syncytial virus [4][5]. Efficacy Data - The phase three trial involved over 40,000 adults aged 50 and above, showing that Moderna's mRNA-1010 vaccine was 26.6% more effective than the standard competitor vaccine [5]. - The mRNA-1010 vaccine demonstrated strong efficacy against major influenza strains, with a 27.4% higher effectiveness in adults aged 65 and older compared to the standard flu vaccine [6]. Public Health Context - Moderna's CEO highlighted the importance of effective vaccines, especially given that flu-related hospitalizations reached a 15-year high during the 2024 to 2025 season, with over 600,000 hospitalizations reported [7]. Safety and Regulatory Engagement - The safety data for the mRNA-1010 vaccine aligns with previous phase three study results, indicating a consistent safety profile [8]. - Moderna is actively engaging with the FDA to clarify regulatory requirements and believes it has a clear path regarding flu vaccine approval [9].