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Inside the Breakthroughs That Shaped Modern Vehicle Safety

Inside the Breakthroughs That Shaped Modern Vehicle Safety

Electronic Stability Control (ESC) has become a cornerstone of automotive safety technology, evolving significantly since its inception. This artic...
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Yen steady as intervention fears linger with Japan shut for holidays

Yen steady as intervention fears linger with Japan shut for holidays

By Gregor Stuart Hunter SINGAPORE, May 4 (Reuters) - The yen stabilised at the start of trading in Asia, strengthening slightly after a few choppy sessions following suspected intervention by authorities to strengthen the currency last week. 
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Mirum Pharmaceuticals Achieves Key Milestone in PSC Treatment with Volixibat

Mirum Pharmaceuticals Achieves Key Milestone in PSC Treatment with Volixibat

Mirum Pharmaceuticals Achieves Key Milestone in PSC Treatment with Volixibat
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FDA Approves Incyte's Jakafi XR for Myelofibrosis, Polycythemia Vera, and Graft-Versus-Host Disease

FDA Approves Incyte's Jakafi XR for Myelofibrosis, Polycythemia Vera, and Graft-Versus-Host Disease

The U.S. Food and Drug Administration (FDA) has approved Jakafi XR, an extended-release formulation of ruxolitinib, for the treatment of several conditions including intermediate- or high-risk myelofibrosis (MF), polycythemia vera (PV) in adults intolerant to hydroxyurea, and both acute and chronic graft-versus-host disease (GVHD) in patients aged 12 and older. Jakafi XR is a once-daily tablet that provides consistent drug exposure comparable to the twice-daily immediate-release version. This approval is based on clinical studies demonstrating bioequivalence between the two formulations. The drug is expected to be available for pharmacy orders by May 8. Incyte, the company behind Jakafi XR, emphasizes its commitment to providing treatment options that meet the evolving needs of patients with myeloproliferative neoplasms and GVHD.
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Insulet Corporation Launches Pivotal Study for Automated Insulin Delivery System for Type 2 Diabetes

Insulet Corporation Launches Pivotal Study for Automated Insulin Delivery System for Type 2 Diabetes

Insulet Corporation Launches Pivotal Study for Automated Insulin Delivery System for Type 2 Diabetes
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FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug

FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug

The Food and Drug Administration (FDA) has granted expanded access to an experimental pancreatic cancer drug, daraxonrasib, developed by Revolution Medicines. This decision allows a broader group of patients to receive the drug while it is still under regulatory review. The FDA's action underscores the urgent need for effective treatments for pancreatic cancer, one of the deadliest forms of cancer. Daraxonrasib has shown promise in clinical trials, doubling the average survival time for patients who have already undergone conventional treatment. The expanded access program, also known as compassionate use, will provide the drug at no cost to eligible patients, although insurance typically does not cover such drugs before approval.
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Sonire Therapeutics Launches U.S. Clinical Trial for Ultrasound-Guided HIFU Therapy in Pancreatic Cancer

Sonire Therapeutics Launches U.S. Clinical Trial for Ultrasound-Guided HIFU Therapy in Pancreatic Cancer

Sonire Therapeutics, a clinical-stage medical device company, has initiated its first U.S. clinical trial, named SUNRISE-II, to evaluate its High-Intensity Focused Ultrasound (HIFU) therapy system for treating pancreatic cancer. This trial marks a significant step in the company's U.S. clinical and regulatory strategy, building on previous developments in Japan. The HIFU system uses real-time ultrasound guidance to perform precise, minimally invasive tumor ablation, potentially reducing the procedural burden on patients and expanding treatment access in outpatient settings. The trial aims to assess the safety and feasibility of this system, which does not require general anesthesia, thus offering a less invasive treatment option for pancreatic cancer, a disease with a notably low five-year survival rate of approximately 13 percent.
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Bambusa Therapeutics Completes Enrollment for Atopic Dermatitis Drug Trial

Bambusa Therapeutics Completes Enrollment for Atopic Dermatitis Drug Trial

Bambusa Therapeutics Completes Enrollment for Atopic Dermatitis Drug Trial
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US FDA authorizes early access to Revolution's pancreatic cancer pill

US FDA authorizes early access to Revolution's pancreatic cancer pill

May 1 (Reuters) - The U.S. Food and Drug Administration has authorized the granting of early access before regulatory approval to Revolution Medicines’ pill for patients with previously treated pancreatic cancer, the company said on Friday.
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FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug for Wider Patient Use

FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug for Wider Patient Use

The Food and Drug Administration (FDA) has announced the granting of 'expanded access' to a promising pancreatic cancer drug, allowing it to be administered to a broader group of patients while it is still under regulatory review. This decision comes in response to an application from Revolution Medicines, the manufacturer of the drug, known as daraxonrasib. The FDA's action is aimed at addressing the urgent need for effective treatments for pancreatic cancer, which is one of the most lethal forms of cancer. The expanded access program, also referred to as 'compassionate use,' will be available to patients who have already undergone conventional treatment. Revolution Medicines has committed to providing the drug at no cost to eligible patients, as insurance typically does not cover drugs that have not yet received full approval.
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Sonire Therapeutics Launches First U.S. Clinical Trial for Pancreatic Cancer Treatment

Sonire Therapeutics Launches First U.S. Clinical Trial for Pancreatic Cancer Treatment

Sonire Therapeutics, a clinical-stage medical device company, has initiated its first U.S. clinical trial, SUNRISE-II, to evaluate its High-Intensity Focused Ultrasound (HIFU) therapy system for treating pancreatic cancer. This trial aims to assess the safety and feasibility of the ultrasound-guided HIFU system, marking a significant milestone in the company's U.S. clinical and regulatory strategy. The trial builds on previous development experience in Japan and represents an important step toward advancing treatment options for pancreatic cancer, a leading cause of cancer-related deaths in the U.S. The HIFU system offers a minimally invasive, anesthesia-free treatment approach, potentially reducing procedural burdens and expanding access to treatment in outpatient settings.
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FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug, Offering Hope to Patients

FDA Grants Expanded Access to Experimental Pancreatic Cancer Drug, Offering Hope to Patients

The Food and Drug Administration (FDA) has granted 'expanded access' to a promising pancreatic cancer drug, daraxonrasib, allowing it to be administered to a broader group of patients while it is still under regulatory review. This decision comes in response to an application from the drug's manufacturer, Revolution Medicines, and was approved just two days after submission. The FDA's swift action underscores the urgent need for effective treatments for pancreatic cancer, which is known for its high mortality rate. Daraxonrasib has shown promising results in clinical trials, doubling the average survival time for patients who have already undergone conventional treatments. The expanded access program, also known as 'compassionate use,' will be available to patients who meet specific criteria, and the drug will be provided at no cost to them.