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NIH launches research network to evaluate emerging cancer screening technologies

The National Institutes of Health (NIH) has launched a clinical trials network to evaluate emerging technologies for cancer screening. The Cancer Screening Research Network (CSRN) will support the Biden-Harris administration’s Cancer Moonshot? by investigating how to identify cancers earlier, when they may be easier to treat. Eight groups have received funding from the National Cancer Institute (NCI), part of NIH, to carry out the initial activities of the network. In 2024, the network will launch a pilot study, known as the Vanguard Study on Multi-Cancer Detection, to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. MCDs are blood tests that can screen for several types of cancers. The study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits… 

FDA Grants Orphan Drug Designation to 9MW3011

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that FDA has granted Orphan Drug Designation (ODD) to 9MW3011 (R&D code in the US: MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy The post Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma appeared first on Bio Tech Winners. Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Santhera gibt Veröffentlichung von Daten zur Wirksamkeit, Sicherheit und Verträglichkeit von Vamorolon (AGAMREE®) bei Patienten mit Duchenne-Muskeldystrophie in Neurology bekannt

Pratteln, Schweiz, 14. Februar 2024 – Santhera Pharmaceuticals (SIX: SANN) gibt die Veröffentlichung der Publikation „Efficacy and Safety of Vamorolone Over 48 Weeks in Boys With Duchenne Muscular Dystrophy“ in der Fachzeitschrift Neurology [2] bekannt. Die Veröffentlichung berichtet über die Ergebnisse der 48-wöchigen Behandlung mit Vamorolon bei Patienten mit DMD in der VISION-DMD Studie. Sie bestätigt das langfristige Wirksamkeits- und Sicherheitsprofil sowie die im Allgemeinen gute Verträglichkeit von Vamorolon, in Übereinstimmung mit den Studienergebnissen nach 24 Wochen, die zuvor in JAMA Neurology [3] veröffentlicht wurden. Santhera gibt Veröffentlichung von Daten zur Wirksamkeit, Sicherheit und Verträglichkeit von Vamorolon (AGAMREE®) bei Patienten mit Duchenne-Muskeldystrophie in Neurology bekannt

Greenwich LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01

STAFFORD, Texas, Feb. 14, 2024 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the „Company“), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on the Phase III clinical trial, Flamingo-01. Greenwich LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01

FDA Approves First Medication to Treat Severe Frostbite

The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. „This approval provides patients with the first-ever treatment option for severe frostbite,“ said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. „Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.“ Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and… 

AusperBio Announces Major Progress in AHB-137 Clinical Development

AHB-137, empowered by AusperBio’s proprietary Med-OligoTM ASO technology platform, holds the potential as a backbone in the quest for a functional cure for CHB. This novel dual-mechanism ASO has been evaluated in two Phase 1a/1b clinical trials in parallel, one in China and another outside China. To date, 122 participants, including 30 CHB patients, have received either single or multiple doses of AHB-137. In China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993), enrollment of CHB patients in the 150mg and 300mg cohorts has been completed. The study outside China (clinicaltrials.gov #NCT05717686) is also rapidly progressing in dosing of CHB patients, with 6 participants having completed 4-week dosing in the US and New Zealand. About Chronic Hepatitis B Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases…