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Novo Nordisk Faces Market Challenges Amidst GLP-1 Competition and Analyst Downgrades

Novo Nordisk Faces Market Challenges Amidst GLP-1 Competition and Analyst Downgrades

Novo Nordisk Faces Market Challenges Amidst GLP-1 Competition and Analyst Downgrades
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Summit Therapeutics Faces High Volatility Amid Lung Cancer Drug Trial Optimism

Summit Therapeutics Faces High Volatility Amid Lung Cancer Drug Trial Optimism

Summit Therapeutics Faces High Volatility Amid Lung Cancer Drug Trial Optimism
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Japanese Pharmaceutical Companies Expand M Activities in U.S. and Europe

Japanese Pharmaceutical Companies Expand M Activities in U.S. and Europe

Japanese Pharmaceutical Companies Expand M Activities in U.S. and Europe
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FDA Qualifies PathAI's AIM-MASH Tool, Revolutionizing MASH Clinical Trials

FDA Qualifies PathAI's AIM-MASH Tool, Revolutionizing MASH Clinical Trials

PathAI has achieved a significant milestone with the FDA qualification of its AIM-MASH AI Assist tool, marking it as the first AI-powered pathology biomarker to receive such status under the FDA's Drug Development Tool program. This follows a similar qualification from the European Medicines Agency, establishing AIM-MASH as the first tool with dual U.S. and EU regulatory recognition. The tool addresses variability in MASH clinical trials by standardizing liver biopsy scoring, thus reducing human variability and enabling more accurate enrollment and endpoint assessment.
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Amgen Integrates Sustainability with Biotech Innovations in Global Operations

Amgen Integrates Sustainability with Biotech Innovations in Global Operations

Amgen Integrates Sustainability with Biotech Innovations in Global Operations
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FDA Approves Flow Neuroscience's At-Home Brain Stimulation Device for Depression Treatment

FDA Approves Flow Neuroscience's At-Home Brain Stimulation Device for Depression Treatment

Flow Neuroscience has received FDA approval for its at-home brain stimulation device, Flow, designed to treat major depressive disorder (MDD). This marks the first time a non-drug therapy for depression can be prescribed for home use in the U.S. The device uses transcranial direct current stimulation (tDCS) to apply a gentle electrical current to the prefrontal cortex, which is often underactive in people with depression. The approval follows a landmark clinical study published in Nature Medicine, demonstrating significant symptom reduction in patients using the device. The study showed that 58% of patients achieved remission by the end of a 10-week period, with the device proving effective even for those already on medication or psychotherapy. Flow's device has been used by over 55,000 people in Europe and is expected to be available in the U.S. by Q2 2026.
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Amazon to pay more than $580 million to settle tax probe in Italy

Amazon to pay more than $580 million to settle tax probe in Italy

By Emilio Parodi MILAN, Dec 10 (Reuters) - Amazon has agreed with Italy's tax collection agency to pay 510 million euros ($582 million) to settle a tax dispute, two sources close to the matter said on Wednesday, in one of a number of cases involving the company in Italy.
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Stocks rise, yields and dollar fall after Fed cuts interest rates 

Stocks rise, yields and dollar fall after Fed cuts interest rates 

By Caroline Valetkevitch NEW YORK, Dec 10 (Reuters) - Major stock indexes jumped while U.S.
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Nvidia's Financial Performance and Strategic Moves Highlight Growth and Challenges

Nvidia's Financial Performance and Strategic Moves Highlight Growth and Challenges

Nvidia's Financial Performance and Strategic Moves Highlight Growth and Challenges
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Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results

Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results

Regeneron Advances Lynozyfic for Untreated Multiple Myeloma with Promising Study Results
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Kite Announces Promising Data for Anito-cel in Multiple Myeloma Patients

Kite Announces Promising Data for Anito-cel in Multiple Myeloma Patients

Kite Announces Promising Data for Anito-cel in Multiple Myeloma Patients
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Kallyope Reports Positive Phase 2b Results for Migraine Treatment Elismetrep

Kallyope Reports Positive Phase 2b Results for Migraine Treatment Elismetrep

Kallyope, a biotechnology company, has announced positive results from a Phase 2b study of elismetrep, a novel TRPM8 antagonist for the acute treatment of migraines. The study involved 431 patients in the U.S. and demonstrated that elismetrep was effective in achieving pain freedom, pain relief, and alleviating migraine-associated symptoms. The drug was well tolerated, with no significant safety concerns. Elismetrep targets the TRPM8 ion channel, which is genetically linked to migraines, offering a new therapeutic option for patients who do not respond well to existing treatments.