DiaCarta Partners with HMC/HML for Lab Development Test Validations and Compliances in the US Market

DiaCarta Inc., a leading molecular diagnostic test developer for cancer and infectious diseases, has announced a strategic partnership with Hopkins MedTech Compliance (HMC) and Hopkins MedTech Lab Services (HML) to address the regulatory compliance and laboratory developed test (LDT) validation needs in the United States. This collaboration aims to provide support to companies that have develope..

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  • · 2023. 7. 24.
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Nectero Medical Receives FDA Clearance of IND Application to Initiate Phase II/III Clinical Trial of Nectero EAST® System for Treatment of Small- to Mid-Sized Abdominal Aortic Aneurysms

Nectero Medical has received FDA clearance to begin a Phase II/III clinical trial for their Nectero EAST® System, which aims to treat small- to mid-sized abdominal aortic aneurysms. &nbsp In an exciting development, Nectero Medical, a clinical-stage biotechnology company focused on improving the lives of patients with aneurysmal disease, announced that they have been granted Investigational New ..

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  • · 2023. 7. 24.
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PaxMedica Announces Positive Top Line Results from the PAX-101 (intravenous suramin) Phase 3 African Sleeping Sickness Study

PaxMedica, a clinical stage biopharmaceutical company, has announced positive top line results from the PAX-101 Phase 3 African Sleeping Sickness study. The study successfully achieved its primary endpoint and demonstrated statistically significant and clinically meaningful results. These findings are an important step towards filing an NDA for the use of PAX-101 in the treatment of African Slee..

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  • · 2023. 7. 24.
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Grifols Achieves Positive Topline Results From Phase 4 Study of XEMBIFY® (immune

Grifols, a global leader in the production of plasma-derived medicines, has announced positive results from a Phase 4 study investigating the use of XEMBIFY®, its subcutaneous immunoglobulin product, administered every two weeks. The study successfully met its primary objective by demonstrating comparable levels of total immunoglobulins when compared to weekly administration in patients with pri..

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  • · 2023. 7. 21.
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Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita

Palvella Therapeutics, a clinical-stage biopharmaceutical company, has released the topline results from its Phase 3 VAPAUS study of QTORIN™ rapamycin gel for the treatment of Pachyonychia Congenita (PC). The study did not show a treatment effect on the primary endpoint. However, it is important to note that the drug was well-tolerated with no serious adverse events reported. As a result, Palvel..

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  • · 2023. 7. 21.
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23andMe Releases New FDA-Cleared Genetic Report on Simvastatin

23andMe Releases New FDA-Cleared Genetic Report on Simvastatin, a Commonly Prescribed Statin In an exciting development, 23andMe has become the first and only direct-to-consumer product to offer a suite of FDA-authorized pharmacogenetics reports, providing valuable medication insights. One such report focuses on simvastatin, a widely prescribed lipid-lowering statin. Genetics can significantly i..

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  • · 2023. 7. 21.
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Hoth Therapeutics Receives Protocol Approval for HT-001 Cancer Therapeutic

Hoth Therapeutics, a biopharmaceutical company focused on patient care, has recently received protocol approval for its cancer therapeutic, HT-001. This exciting development was announced on July 19, 2023. &nbsp The FDA-approved trial now has two sites approved for conducting the study, and additional sites are currently in the approval process. This means that recruitment of patients can now be..

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  • · 2023. 7. 19.
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Synaptogenix and Cleveland Clinic to Submit Investigational New Drug (IND) Application to FDA for Clinical Trial of Bryostatin-1 in Multiple Sclerosis

Synaptogenix, Inc. (Nasdaq: SNPX) has announced a collaboration with Cleveland Clinic to conduct a phase 1 trial of Bryostatin-1 in multiple sclerosis (MS). The study aims to evaluate the drug's potential neuro-restorative mechanism(s) of action for improving synaptic health and cognitive function in MS patients. Cleveland Clinic will oversee the implementation of the clinical trial, which inclu..

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  • · 2023. 7. 19.
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Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors

Adcentrx Therapeutics Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ADRX-0706, a groundbreaking Antibody-Drug Conjugate (ADC) that targets Nectin-4 to treat advanced solid tumors. This marks the first time that Adcentrx's ADC platform has been granted FDA clearance, signaling a major milestone for the company. ..

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  • · 2023. 7. 18.
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Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., has recently announced that the U.S. Food and Drug Administration (FDA) has accepted their new drug application (NDA) for rivoceranib in combination with camrelizumab as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC). This is great news for patients and healthcare professionals as it provides..

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  • · 2023. 7. 18.
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