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Canceling Moderna's bird flu contract is reckless and dangerous

Canceling Moderna's bird flu contract is reckless and dangerous

Boston Globe2 days ago

Bird flu — specifically the H5N1 strain of avian influenza — is deadly and unpredictable, and it continues to evolve in ways that have raised real concerns among virologists and public health experts. Historically, about half the people infected with the virus have died — and unlike other respiratory viruses, it doesn't spare the young or healthy. The virus, traditionally confined to birds (thus the name), is now spreading more broadly among mammals. There have been large-scale die-offs of seals. More recently, there have been infections among bears, in more than
In the United States, dozens of people have tested positive for H5N1, many of whom are workers on dairy farms. One person — a man over the age of 65 from Louisiana — died earlier this year. Globally, the virus has also caused other tragic outcomes, including the death of a
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To date, nearly all known human cases have likely come from direct contact with infected animals or their secretions, such as milk. Many of these kinds of infections — the ones that come from physical contact as opposed to respiratory droplets — can be milder, including pink eye-like symptoms.
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The virus has yet to spread easily from person to person. That could change, and H5N1 could spread airborne, similar to COVID-19. And if it does, the world could be staring down a pandemic far worse than COVID-19.
That's the threat that prompted the Biden administration to invest in next-generation vaccines against H5N1. It awarded a $600 million contract to Moderna — the folks who developed one of the first successful and effective mRNA-based COVID-19 vaccines — to develop an mRNA-based vaccine against H5N1. That's the contract Kennedy has canceled. It's a decision that defies logic and appears rooted in both a hatred of vaccines and a fear of the mRNA platform. Most importantly, it puts the lives and health of the American people at risk and undercuts years of scientific progress.
We've seen what's possible when we invest early. The mRNA platform that gave the nation life-saving COVID-19 vaccines was the result of more than a decade of research, much of it funded by the National Institutes of Health. Scientists spent years studying coronaviruses, particularly the original SARS virus, and developed a detailed game plan for a vaccine against that virus. That foundational work gave our nation a head start when SARS-CoV-2 hit, allowing the quick development of vaccines and for Operation Warp Speed, which took place during the first Trump administration, to test those vaccines rapidly. That same foresight was driving the Moderna bird flu contract and research.
Developing and refining an mRNA vaccine demands testing and time. Scientists must design and test the antigen, determine optimal dosing, and assess safety and effectiveness — work that takes months and often years. Waiting to develop a vaccine candidate until the world is actually confronting a bird flu pandemic would leave America dangerously behind. That's why investing in a human vaccine is one of the
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This is exactly the kind of public health challenge the government should address. There's no viable commercial market for an H5N1 vaccine — and if we're lucky, there never will be. We cannot rely on the private sector to invest in pandemic prevention. And waiting to develop vaccines until a pandemic has started is like telling a fire department to start hiring after a neighborhood has gone up in flames.
The rationale behind the contract's cancellation doesn't hold up. HHS cited safety concerns with mRNA vaccines, calling continued investment in Moderna's vaccine '
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This isn't just about H5N1. The mRNA platform is a breakthrough technology that can be adapted for a wide range of threats, from emerging viruses to
The federal government should be investing and working to expand the nation's scientific and public health arsenal, not shrinking it. The systems we build today — the research, the platforms, the partnerships — are what protect us tomorrow. Canceling this contract undermines progress, weakens readiness, and increases the odds that we'll be caught flat-footed when the next pandemic strikes.
And if that pandemic is driven by a virus as deadly as bird flu, the cost won't just be measured in dollars — it will be measured in lives.

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Health officials sound alarm as 'deadliest animal on the planet' spreads across southern US — here's what you need to know
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Officials in Texas have sounded the alarm after recent storms left prime breeding conditions just in time for peak mosquito season, the Austin American-Statesman reported. Local experts are particularly concerned about the spread of mosquito-borne diseases like West Nile and Zika. Already facing an uphill battle as rising global temperatures expand peak mosquito season beyond its traditional dates, Texas officials in charge of managing mosquito populations now must combat high levels of standing water and hot, humid conditions perfect for mosquito reproduction, per the American-Statesman. "We've seen the weather changing over the years here in Austin, and as a result, we've seen mosquito seasons running longer than before," Marcel Elizondo, chief of Austin's Environmental Health Services division, said in a statement. Mosquitoes are an annoyance for some; for others, they can be deadly. According to the American Mosquito Control Association, over 1 million people around the world die every single year from mosquito-borne diseases. "Mosquitos are the deadliest animals on the planet," Bethany Bolling, who oversees mosquito virus testing at the Texas Department of State Health Services, told KXAN. Mosquitoes transmit disease through their bites, spreading deadly illnesses like malaria and dengue in addition to West Nile and Zika, according to the U.S. Centers for Disease Control and Prevention. Malaria alone is responsible for over 600,000 preventable deaths annually. Mosquitoes are a prime example of the negative impacts that rising global temperatures have on human health. In addition to hotter temperatures, changes in weather patterns are causing increased rainfall in certain areas, creating the perfect breeding grounds for mosquitoes, according to the U.S. Environmental Protection Agency. Rising temperatures can influence the way mosquitoes spread disease in other ways, too. "Studies show that warmer temperatures associated with climate change can accelerate mosquito development, biting rates, and the incubation of the disease within a mosquito," according to the EPA. Do you worry about getting diseases from bug bites? Absolutely Only when I'm camping or hiking Not really Never Click your choice to see results and speak your mind. While public health officials monitor mosquito populations and test breeding grounds for diseases like West Nile, there are several things that you can do to help protect yourself and your family. First, try to eliminate all standing water, as that is the primary breeding ground for mosquitoes. This includes places like clogged gutters, plant saucers, buckets, and toys, according to Austin Public Health. If you have bird baths or other outdoor water for animals, make sure to change it at least once a week to prevent mosquitoes from developing. Next, make sure to repair all leaky faucets and pipes, as these can provide sources of the moisture mosquitoes need to reproduce. Similarly, if you have a rainwater cistern, make sure it is properly sealed to prevent mosquitoes from entering. Finally, if you have permanent standing water on your property, such as a pond, you can purchase a mosquito dunk, which contains a biological larvicide that will kill young mosquitoes, per Austin Public Health. Join our free newsletter for weekly updates on the latest innovations improving our lives and shaping our future, and don't miss this cool list of easy ways to help yourself while helping the planet.

Are you among adults who don't know you have diabetes, hypertension?
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A significant number of adults in the U.S. don't know that they have high blood pressure, diabetes or bad total cholesterol numbers, which all contribute to the risk of death from cardiovascular disease. And awareness may be even worse now because COVID-19 disrupted preventive screenings. That's according to a new study in the journal JAMA Cardiology from researchers at Beth Israel Deaconess Medical Center, the Pritzker School of Medicine at the University of Chicago and the Harvard T.H. Chan School of Public Health. The research involved 15,269 nonpregnant adults 20 or older (average age 56.8 years) who had cardiovascular risk factors between 2013 and 2023, using the National Health and Nutrition Examination Survey. The researchers looked specifically at how many didn't know their own health status for those conditions, which was learned through a household interview and then a medical examination. 'The proportion of U.S. adults who were unaware of having hypertension increased significantly over the study period, particularly in young adults and women, while diabetes and high cholesterol level unawareness remained stable. By the 2021 to 2023 cycle, approximately 1 in 6 adults with hypertension and 3 in 10 with diabetes were unaware of their condition,' per the study. The adults who had been identified as having a cardiovascular risk factor but who reported not being told by a health professional that they had the factor were classified as unaware. 'Given declining cardiometabolic health in young adults,' the authors expressed concern that about one-third of those with hypertension, 2 in 5 with diabetes and 1 in 4 with high cholesterol are not aware of their own situation. They added that 'policy efforts to address these gaps in awareness are needed to prevent future cardiovascular events.' The researchers found that across the entire age range studied, 17.8% who had hypertension didn't know it in 2021-2023, compared to 14.6% in 2013-2014. The proportion of adults who didn't know they had diabetes did not change significantly, going from 27.5% to 28.9%. The share with high cholesterol who didn't know was also stable, at 11.5% and 11.9% respectively. But age made a difference. The proportion of young adults ages 20-44 who didn't know they had hypertension rose from 21.9% to 37.1%. Awareness of that didn't change for those 45 and older, or among different age groups who had undiagnosed diabetes or high cholesterol. Lack of awareness of having high blood pressure rose significantly over the study period in women, to 16.5%. All three of those conditions are treatable. Left untreated, however, they can cause severe problems or kill. They are considered 'modifiable risk factors' for cardiovascular disease. 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Those with diabetes are also more apt to have high blood pressure and so-called 'bad' cholesterol — along with the increased risk those conditions bring. They are also more likely to experience heart failure, where the heart pumps less efficiently, which can also lead to a buildup of fluid in the lungs, making breathing both miserable and difficult. Cleveland Clinic reports that about half of U.S. adults have some form of cardiovascular disease and that 1 in 3 women die from it. Among the risk factors — besides hypertension, high cholesterol and type 2 diabetes — are tobacco use including vaping, genetics, lack of exercise, an unhealthy diet, overuse of alcohol, misuse of prescription and recreational drugs, some chronic autoimmune or inflammatory conditions, chronic kidney disease, and certain pregnancy-related complications. 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HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma
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HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. ('Innovent') (HKEX: 01801) today jointly announce that the New Drug Application ('NDA') for the combination of fruquintinib and sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor ('TKI') has been accepted for review by the China National Medical Products Administration ('NMPA'). The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma. The study has met its primary endpoint of progression free survival ('PFS'), as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate ('ORR') and duration of response ('DoR'). The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference. Additional details may be found at using identifier NCT05522231. 'Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies. Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need,' said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. 'We are dedicated to making this combination therapy available to patients with renal cell carcinoma. At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options.' 'The NDA acceptance of sintilimab and fruquintinib combination represents a significant step toward providing a more effective second line treatment option for patients with advanced renal cell carcinoma in China,' said Dr Hui Zhou, Senior Vice President of Innovent. 'Our PD-1 inhibitor, sintilimab (TYVYT®), has solidified its position as a cornerstone of immuno-oncology (IO) therapy with this NDA as its 10th indication, marking a meaningful milestone in lifecycle management and clinical value optimization.' In December 2024, the combination of fruquintinib and sintilimab received conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient ('pMMR') endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705). About Kidney Cancer and Renal Cell Carcinoma It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.1 In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.2 Approximately 90% of kidney tumors are renal cell carcinoma. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ('VEGFR') -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.3 About Fruquintinib Approvals Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. The combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US, Europe, Japan and many other countries around the world. The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated: About Fruquintinib for Second-line Treatment of Renal Cell Carcinoma Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced renal cell carcinoma in China. Notably, advanced renal cell carcinoma patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need. Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination showed promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival ('OS') was not reached, and the 36-month OS rate was 58.3%.4 About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed and co-commercialized by Innovent and Eli Lilly and Company, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. 5 In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. Two NDAs for sintilimab are currently under the NMPA review, including: In combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation; In combination with fruquintinib for the treatment of patients with locally advanced or metastatic renal cell carcinoma who failed prior treatment with a TKI. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy; Statement: Innovent does not recommend the use of any unapproved drug(s)/indication(s). About HUTCHMED HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception, HUTCHMED has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit or follow us on LinkedIn. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit or follow Innovent on Facebook and LinkedIn. Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication(s). (2) Ramucirumab (Cyramza ® ) and Selpercatinib (Retsevmo ® ) and Pirtobrutinib (Jaypirca ® ) were developed by Eli Lilly and Company. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including its expectations regarding the therapeutic potential of the fruquintinib and sintilimab combination for the treatment of patients with advanced renal cell carcinoma and the further clinical development of the fruquintinib and sintilimab combination in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of the fruquintinib and sintilimab combination for the treatment of patients with advanced renal cell carcinoma in China, or other jurisdictions, its potential to gain expeditious approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED's ability to fund, implement and complete its further clinical development and commercialization plans for the fruquintinib and sintilimab combination, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as sintilimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / [email protected] Media Enquiries FTI Consulting – +44 20 3727 1030 / [email protected] Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / [email protected] Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 ____________________ 1 The Global Cancer Observatory, kidney cancer fact sheet. Accessed February 19, 2025. 2 The Global Cancer Observatory, China fact sheet. Accessed February 19, 2025. 3 Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther . 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087. 4 Xu H, et al. Fruquintinib Plus Sintilimab in Patients with Treatment‑Naïve and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Targeted Oncolog y. 2025; 20:113–125. 5 Wang J, et al . Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. doi: 10.1080/19420862.2019.1654303. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.

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