Twenty Deaths in Japan Linked to Tavneos Use
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy AMGN?
Source: seekingalpha
- Drug Safety Concerns: In Japan, 20 deaths have been reported linked to the use of Tavneos, developed by Amgen, prompting Kissei to advise healthcare professionals to exercise caution in prescribing the drug, emphasizing the need to refrain from using it for new patients to ensure safety.
- Liver Injury Risks: At least 22 individuals have developed potentially fatal liver injuries after taking Tavneos, leading Kissei to provide information to healthcare professionals urging careful assessment of treatment continuation for existing patients, ensuring they understand the risks of liver dysfunction and alternative treatment options.
- Market Impact: Tavneos, marketed in Japan since 2022 for specific rare diseases, is projected to generate ¥11.5 billion by the fiscal year ending March 2026; however, Kissei has yet to assess the financial impact of these safety concerns, which could pressure future sales.
- Increased Regulatory Scrutiny: The U.S. FDA previously considered withdrawing Tavneos from the market due to safety issues and potential data manipulation, highlighting ongoing controversies regarding the drug's safety, which may affect its market acceptance and sales outlook.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to rise
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 336.230
Low
280.00
Averages
363.10
High
425.00
Current: 336.230
Low
280.00
Averages
363.10
High
425.00
About AMGN
Amgen Inc. is a biotechnology company. It discovers, develops, manufactures and delivers medicines for the toughest diseases. It focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve people’s lives. It operates in the human therapeutics segment. Its marketed products portfolio includes EPOGEN (epoetin alfa); Aranesp (darbepoetin alfa); Parsabiv (etelcalcetide); Neulasta (pegfilgrastim); KANJINTI (trastuzumab-anns); Otezla; BLINCYTO (blinatumomab); ACTIMMUNE (interferon gamma-1b); Neulasta (pegfilgrastim); Sensipar/Mimpara (cinacalcet); Prolia (denosumab); ENBREL; QUINSAIR (levofloxacin); Repatha (evolocumab) and others. It markets ENBREL, a tumor necrosis factor blocker, in the United States and Canada. It markets Otezla, a small molecule that inhibits phosphodiesterase 4, in many countries around the world. It markets Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in many countries around the world.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Twenty Deaths in Japan Linked to Tavneos Use
- Drug Safety Concerns: In Japan, 20 deaths have been reported linked to the use of Tavneos, developed by Amgen, prompting Kissei to advise healthcare professionals to exercise caution in prescribing the drug, emphasizing the need to refrain from using it for new patients to ensure safety.
- Liver Injury Risks: At least 22 individuals have developed potentially fatal liver injuries after taking Tavneos, leading Kissei to provide information to healthcare professionals urging careful assessment of treatment continuation for existing patients, ensuring they understand the risks of liver dysfunction and alternative treatment options.
- Market Impact: Tavneos, marketed in Japan since 2022 for specific rare diseases, is projected to generate ¥11.5 billion by the fiscal year ending March 2026; however, Kissei has yet to assess the financial impact of these safety concerns, which could pressure future sales.
- Increased Regulatory Scrutiny: The U.S. FDA previously considered withdrawing Tavneos from the market due to safety issues and potential data manipulation, highlighting ongoing controversies regarding the drug's safety, which may affect its market acceptance and sales outlook.
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- Sales Expectations: Icotyde is projected to reach $10.5 billion in sales by 2032, significantly exceeding Wall Street's consensus of $7.4 billion, indicating strong market potential, especially after securing approvals for conditions like Crohn's disease and ulcerative colitis.
- Market Competition: Despite the convenience of Icotyde, analysts express skepticism about its ability to surpass existing biologics like Tremfya and AbbVie's Skyrizi, suggesting that patients may prefer quarterly injections over daily pills.
- Strategic Positioning: J&J's CEO stated that Icotyde, alongside Tremfya, forms a crucial part of the company's immunology portfolio aimed at replacing declining sales from Stelara, which peaked at nearly $11 billion in 2023 but is expected to see significant declines in the future.
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- Shift in R&D Model: This collaboration represents a departure from traditional licensing agreements, as both companies will contribute resources to drug development, positioning China as a vital part of the global pharmaceutical R&D ecosystem and highlighting U.S. drugmakers' increasing focus on the Chinese market.
- Market Trend Shift: According to DealForma, over half of large pharmaceutical licensing deals this year have originated from China, up from 39% last year, indicating a growing trend among U.S. and European biopharmaceutical companies to shift early drug development to China to expedite market entry.
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- Strategic Partnership Agreement: Oncotelic has finalized a strategic agreement with Lunai Bioworks, transferring global rights to the N2B system for applications in biodefense and Alzheimer's disease, highlighting the company's strategic focus on drug delivery infrastructure.
- Global Challenge of Alzheimer's: Approximately 57 million people worldwide currently live with dementia, a figure projected to rise sharply with aging populations, and Oncotelic's technology aims to provide more effective treatment solutions in this area.
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- Strategic Partnership Agreement: Oncotelic has finalized a strategic monetization agreement with Lunai Bioworks, granting global rights to the N2B delivery system for biodefense and Alzheimer's applications, highlighting the company's strategic focus on core asset control.
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- Rapid Growth of AI Cardiology Market: The global AI cardiology market is projected to grow from $2.78 billion this year to over $14 billion by 2034, reflecting a strong demand for innovative technologies as health systems rush to deploy machine learning tools to address diagnostic backlogs.
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Twenty Deaths in Japan Linked to Tavneos Use
- Drug Safety Concerns: In Japan, 20 deaths have been reported linked to the use of Tavneos, developed by Amgen, prompting Kissei to advise healthcare professionals to exercise caution in prescribing the drug, emphasizing the need to refrain from using it for new patients to ensure safety.
- Liver Injury Risks: At least 22 individuals have developed potentially fatal liver injuries after taking Tavneos, leading Kissei to provide information to healthcare professionals urging careful assessment of treatment continuation for existing patients, ensuring they understand the risks of liver dysfunction and alternative treatment options.
- Market Impact: Tavneos, marketed in Japan since 2022 for specific rare diseases, is projected to generate ¥11.5 billion by the fiscal year ending March 2026; however, Kissei has yet to assess the financial impact of these safety concerns, which could pressure future sales.
- Increased Regulatory Scrutiny: The U.S. FDA previously considered withdrawing Tavneos from the market due to safety issues and potential data manipulation, highlighting ongoing controversies regarding the drug's safety, which may affect its market acceptance and sales outlook.
See More
Johnson & Johnson's Icotyde Shows Strong Potential as a Cash Cow
- New Drug Launch: Johnson & Johnson's newly launched oral medication Icotyde received FDA approval in mid-March for moderate to severe plaque psoriasis, becoming the first oral treatment targeting the IL-23 receptor, and is expected to become a new cash cow for the company.
- Sales Expectations: Icotyde is projected to reach $10.5 billion in sales by 2032, significantly exceeding Wall Street's consensus of $7.4 billion, indicating strong market potential, especially after securing approvals for conditions like Crohn's disease and ulcerative colitis.
- Market Competition: Despite the convenience of Icotyde, analysts express skepticism about its ability to surpass existing biologics like Tremfya and AbbVie's Skyrizi, suggesting that patients may prefer quarterly injections over daily pills.
- Strategic Positioning: J&J's CEO stated that Icotyde, alongside Tremfya, forms a crucial part of the company's immunology portfolio aimed at replacing declining sales from Stelara, which peaked at nearly $11 billion in 2023 but is expected to see significant declines in the future.
See More
Bristol Myers Squibb Partners with Hengrui Pharma for Drug Development
- Significant Partnership: Bristol Myers Squibb has announced a potential multi-billion dollar partnership with Hengrui Pharma, aiming to co-develop around a dozen drugs, including four that Bristol will send to China for early-stage clinical trials, marking a new phase of international collaboration in drug development.
- Shift in R&D Model: This collaboration represents a departure from traditional licensing agreements, as both companies will contribute resources to drug development, positioning China as a vital part of the global pharmaceutical R&D ecosystem and highlighting U.S. drugmakers' increasing focus on the Chinese market.
- Market Trend Shift: According to DealForma, over half of large pharmaceutical licensing deals this year have originated from China, up from 39% last year, indicating a growing trend among U.S. and European biopharmaceutical companies to shift early drug development to China to expedite market entry.
- Future Industry Outlook: Experts predict that early-stage drug discovery will increasingly move to China due to its ability to conduct studies at lower costs and faster timelines, potentially reshaping the U.S. pharmaceutical landscape and encouraging more companies to initiate early clinical trials in China.
See More
Oncotelic Launches Innovative Brain Drug Delivery System
- Breakthrough Delivery Technology: Oncotelic Therapeutics' N2B system enables rapid drug delivery to the brain, marking a consensus in the biopharma industry that delivery innovation will drive significant breakthroughs in central nervous system (CNS) medicine.
- Strategic Partnership Agreement: Oncotelic has finalized a strategic agreement with Lunai Bioworks, transferring global rights to the N2B system for applications in biodefense and Alzheimer's disease, highlighting the company's strategic focus on drug delivery infrastructure.
- Global Challenge of Alzheimer's: Approximately 57 million people worldwide currently live with dementia, a figure projected to rise sharply with aging populations, and Oncotelic's technology aims to provide more effective treatment solutions in this area.
- Dual Market Potential: The N2B system from Oncotelic addresses not only chronic diseases but also national security and biodefense needs, reflecting the broad applicability of its technology in both commercial medicine and government-funded projects.
See More
Oncotelic Launches Innovative Brain Drug Delivery System
- Breakthrough Delivery Technology: Oncotelic Therapeutics' N2B delivery system enables rapid transport of therapeutics to the brain, marking a consensus in the biopharma industry that delivery innovation will drive the next wave of breakthroughs in CNS medicine.
- Strategic Partnership Agreement: Oncotelic has finalized a strategic monetization agreement with Lunai Bioworks, granting global rights to the N2B delivery system for biodefense and Alzheimer's applications, highlighting the company's strategic focus on core asset control.
- Global Alzheimer's Challenge: Approximately 57 million people worldwide currently live with dementia, a figure projected to rise sharply with aging populations, and Oncotelic's technology aims to address the delivery bottleneck to improve treatment outcomes.
- Dual Market Potential: Oncotelic's delivery technology is applicable not only to chronic diseases but also to national security and biodefense needs, reflecting its broad applicability in both commercial medicine and government-funded initiatives.
See More
Cardiovascular Disease Costs Set to Skyrocket, Urgent Need for AI Solutions
- Rising Cardiovascular Costs: The American Heart Association warns that U.S. heart disease costs are set to quadruple by 2050, with national healthcare spending nearing $5 trillion, compelling hospitals to rethink their diagnostic and treatment strategies for cardiac patients, thereby driving structural changes in the healthcare industry.
- Rapid Growth of AI Cardiology Market: The global AI cardiology market is projected to grow from $2.78 billion this year to over $14 billion by 2034, reflecting a strong demand for innovative technologies as health systems rush to deploy machine learning tools to address diagnostic backlogs.
- Showcasing VMS+™ 4.0 Technology: VentriPoint Diagnostics will showcase its AI-powered cardiac imaging platform at the AEPC conference in Italy, which converts standard 2D ultrasound scans into detailed 3D heart models, providing results comparable to cardiac MRI without the need for expensive machines and long wait times.
- International Collaborations and Market Expansion: VentriPoint has established partnerships for regulatory approval of VMS+™ 4.0 in China and is promoting cardiac diagnostics in Costa Rica and Indigenous communities in Canada, demonstrating its potential for global market expansion and commercial momentum.
See More
