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Biotechnology Market is Expanding USD 3,995.22 Billion By 2032
https://www.biospace.com/article/releases/biotechnology-market-is-expanding-usd-3-995-22-billion-by-2032/
R&D Day and Business Updates at 1:00 p.m. ET on Wednesday, September 13, 2023
stay tuned$$$$$$$$
A Synthetic RNA Export System Reveals the Dynamic Lives of Cells and Suggests Direction for New Therapeutics
https://www.caltech.edu/about/news/a-synthetic-rna-export-system-reveals-the-dynamic-lives-of-cells-and-suggests-direction-for-new-therapeutics
CARsgen and Moderna have initiated a collaboration agreement to investigate CT041 in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.
Business Highlights
Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine.
CT041 has achieved IND clearance from the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer (PC).
CT041 Phase 2 clinical trial has been initiated in the U.S. for the treatment of Claudin18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of systemic therapies.
https://www.nasdaq.com/press-release/carsgen-announced-2023-interim-results-2023-08-22
welcome back!!!!! we have a winner MRNA
everything is possible$$$$$$$$$
go pick tomatoes.....
Moderna, CARsgen Join Forces Combining mRNA Cancer Vaccine with CAR T.......
https://www.biospace.com/article/moderna-carsgen-join-forces-combining-mrna-cancer-vaccine-with-car-t/
Last month, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. If approved, mRNA-1345 could be Moderna’s second product launch.
Earlier this month, Moderna announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses againstthe influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end. Given the company’s accelerated timetable for mRNA-1010, we expect mRNA-1010 to be the company’s third product launch, expected in the next year.
Data from the study showed that mRNA-4157combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Merck’s Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival.
the work continues$$$$$$$$$$
Moderna's updated COVID vaccine effective against 'Eris' variant in humans
https://finance.yahoo.com/news/moderna-clinical-trial-data-confirm-201500678.html
Revenue: Total revenue for the second quarter of 2023 was $344 million
https://investors.modernatx.com/news/news-details/2023/Moderna-Reports-Second-Quarter-2023-Financial-Results-and-Provides-Business-Updates/default.aspx
Moderna plots lung cancer trial for Merck-partnered vax, piggybacking on Keytruda's recent win
https://www.fiercebiotech.com/biotech/moderna-has-bold-ambitions-merck-partnered-cancer-vaccine-plans-launch-lung-cancer-trial
We expect Moderna MRNA to beat expectations when it releases second-quarter 2023 results on Aug 3, before the opening bell. In the last reported quarter, the company reported an earnings surprise of 110.73%.
The Zacks Consensus Estimate and our model estimate for second-quarter product sales is pegged at $233 million and $246 million, respectively.
Merck and Moderna Initiate Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.
https://www.biospace.com/article/releases/merck-and-moderna-initiate-phase-3-study-evaluating-v940-mrna-4157-in-combination-with-keytruda-pembrolizumab-for-adjuvant-treatment-of-patients-with-resected-high-risk-stage-iib-iv-melanoma/?keywords=pancreatic+cancer+phase+3
GSK’s Arexvy to lead new RSV vaccines sales race with Moderna a close second:
https://www.fiercepharma.com/marketing/gsks-arexvy-lead-new-rsv-vaccines-sales-race-moderna-close-second-report
Alex Tabarrok writes about how:
I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach-
So what might help me? MRNA tumor vaccines. Head and neck squamous cell carcinomas (HNSCC) are notoriously treatment resistant, and mRNA vaccines have shown huge promise. Why aren’t they happening faster? Because the FDA is slow. There are some trials underway (here is one from Moderna; here is another), and, although I’m trying to enroll, I may be too late, since my cancer moves so aggressively. The FDA was loathe to approve initial mRNA human trials, even when those trials would have been full of people like me: those who are facing death sentences anyway.
https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/
BAVARIAN NORDIC PROVIDES UPDATE ON RSV VACCINE PROGRAM
Phase 3 study failed to meet one of the success criteria of the primary objective
RSV program to be discontinued
https://www.bavarian-nordic.com/investor/news/news.aspx?news=6808
Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial..... "less competition"
https://www.biospace.com/article/vir-s-gsk-backed-flu-vaccine-candidate-fails-phase-ii-trial/
it is better to pick the flowers....-fast-
For more than a decade, we have been at the forefront of groundbreaking #mRNA research that holds immense potential to revolutionize healthcare. Hear more from @cleoabram about how we are studying mRNA to see if one day it can teach our bodies to make its own #medicine. pic.twitter.com/8emxT8yn2P
— Moderna (@moderna_tx) July 19, 2023
Moderna may become a biotech giant by 2030$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
https://www.fool.com/investing/2023/07/19/prediction-company-will-be-a-biotech-giant-by-2030/
we are here to make money!!!!!!!!
Flagship Pioneering and Pfizer Partner to Accelerate Development of Innovative Medicines Targeting Unmet Needs
Flagship Pioneering -He is also co-founder and Board Chairman of Moderna.:
Unity is strength$$$$$$$$$
https://www.pfizer.com/news/press-release/press-release-detail/flagship-pioneering-and-pfizer-partner-accelerate
in the end it will be a success---- cancer vaccine!
Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine
The vaccine is made by profiling each patient’s tumor mutational signature and is designed to induce an immune response against the corresponding antigens. If eventually successful, Merck and Moderna could open up an entirely new area of cancer treatment.
https://www.fiercebiotech.com/biotech/merck-moderna-post-phase-3-trial-closely-watched-mrna-cancer-vaccine
Moderna: Potential To Get Second Product To Market:
Moderna had $16.3 billion in total assets as of the quarter ending March 31, 2023.
The reason why I believe that its financial position should be strong in 2023 is because it still reiterates that its minimum sales for this period will be about $5 billion, thanks to previously announced Covid-19 vaccine Advanced Purchase Agreements. Not only that, but there is something else to consider as well, which is that it is expecting to negotiate new orders for its Covid-19 vaccine in the fall of 2023. Such negotiations that are taking place for this period are with the U.S., Japan, and Europe.
One thing to note is that should the RSV vaccine mRNA-1345 be approved, sales won't start until at least 2024. Still, this biotech is excellent to look into, because it is expecting six major vaccine launches from its respiratory franchise, with expected annual sales of $8 to $15 billion by 2027. The vaccine franchise that I'm talking about deals with Covid-19, RSV, Flu, and even possibly combinations thereof.
https://seekingalpha.com/article/4615604-moderna-potential-to-get-second-product-to-market
“Any medicines produced under this agreement will be exclusively for the Chinese people — who face many of the same health challenges that affect other communities around the world — and will not be exported,” it said.
The official Xinhua news agency reported that Moderna (MRNA) plans to set up its mRNA pipelines in Shanghai’s Minhang District, adding the pharmaceutical firm will build a production plant.
Moderna agrees deal in China with view to developing mRNA medicines
https://finance.yahoo.com/news/1-moderna-agrees-deal-china-095651433.htm
Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia
The Company has also initiated a rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for mRNA-1345
mRNA-1345 met primary efficacy endpoints, demonstrating vaccine efficacy of 83.7% against RSV lower respiratory tract disease in older adults in the Phase 3 pivotal efficacy trial, ConquerRSV
The Company plans further regulatory submissions for mRNA-1345 worldwide
https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Global-Regulatory-Submissions-For-Its-Respiratory-Syncytial-Virus-RSV-Vaccine-MRNA-1345/default.aspx
Moderna to Announce $1 Billion in China Investments, Yicai Says
https://www.bloomberg.com/news/articles/2023-07-04/moderna-to-announce-1-billion-in-china-investments-yicai-says
Revolutionizing Cancer Treatment: The Power of Personalized Vaccines
works in progress
https://scitechdaily.com/revolutionizing-cancer-treatment-the-power-of-personalized-vaccines/
One of the first to receive the ovarian cancer vaccine in a safety study 11 years ago was Jamie Crase of nearby Mercer Island. Diagnosed with advanced ovarian cancer when she was 34, Crase thought she would die young and had made a will that bequeathed a favorite necklace to her best friend. Now 50, she has no sign of cancer and she still wears the necklace.
She doesn't know for sure if the vaccine helped, "But I'm still here."
Vaccines could be the "next big thing" in cancer treatment, scientists say
https://www.cbsnews.com/news/vaccines-cancer-treatment-could-be-next-big-advancement/
Antara Capital LP ownership in NKLA / Nikola Corp
https://fintel.io/so/us/nkla/antara-capital
The next big advance in cancer treatment could be a vaccine
https://apnews.com/article/cancer-vaccines-research-immune-system-c35c8b3003fb75c1a848715a4b4f097f
2023 Anticipated Milestones and Catalysts
Overall response rate and progression-free survival data from phase 2 BRACELET-1 metastatic breast cancer study: Q2 2023
Preclinical data from the combination of pelareorep and CAR T cell therapy: Q2 2023
Updated data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) from the GOBLET study: H2 2023
Update on the metastatic colorectal and anal cancer cohorts from the GOBLET study: H2 2023
Guidance for the registration paths for HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC: H2 2023
MODERNA FILES FOR FDA AUTHORIZATION OF ITS UPDATED COVID-19 VACCINE
https://investors.modernatx.com/news/news-details/2023/Moderna-Files-for-FDA-Authorization-of-Its-Updated-COVID-19-Vaccine/default.aspx
Research and development expenses for the first quarter of 2023 increased by 104% to $1.1 billion, in comparison to the same quarter of 2022. The growth in spending was mainly due to an increase in clinical trial-related expenses, largely driven by increased clinical development activities, particularly with respect to the Company's RSV, seasonal flu and CMV programs. The growth was also driven by an increase in personnel-related costs, due to increased headcount to support research and development efforts, and the Company's recently announced collaboration agreements with Life Edit and Generation Bio....
this is called business...for the future!
Two-birds-one-stone approach to combine protein and mRNA vaccines for COVID-19
https://www.nature.com/articles/s41590-023-01539-5
$MRNA
Precision medicine meets cancer vaccines:
https://www.nature.com/articles/s41591-023-02432-2
Experimental vaccine shows promise in delaying the return of aggressive brain tumor...
John Wishman was diagnosed with the deadliest form of brain cancer, glioblastoma, in fall 2020.
Two and a half years later, he’s still traveling and enjoying life — a rarity for a cancer with an average survival time of just 12 to 18 months.
Wishman, 61, of Buffalo, New York, attributes that to an experimental vaccine that’s designed to delay the progression of the tumor
very nice....
https://www.nbcnews.com/health/health-news/brain-tumor-vaccine-experimental-shot-shows-promise-glioblastoma-rcna83362
Moderna’s
Oncology Trials
https://trials.modernatx.com/oncology/