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NOUL Co., Ltd. has completed establishment registration and device listing with the FDA securing Class 1 medical device approval for four of its products: the #miLab Platform, miLab Cartridge MAL, miLab Cartridge BCM, and SafeFix. https://lnkd.in/gbwsqr5G

CDSCO Panel Grants Novartis Protocol Amendment Proposal To Study Remibrutinib In Chronic Spontaneous Urticaria The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has approved the protocol amendment proposal presented by the drug major Novartis for an extension study of long-term efficacy, safety, and tolerability of Remibrutinib in chronic spontaneous urticaria patients who completed preceding studies with remibrutinib. This came after the drug maker Novartis presented protocol amendment version 01 dated 28.02.2024 protocol No. CLOU064A2303B. #Remibrutinib #cdsco #novartis #protocolamendment #Chronicspontaneousurticaria

FDA approves imaging drug for evaluation of myocardial ischemia and infarction The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia (cardiac function disorder when the heart muscle doesn’t receive enough blood flow to function properly) and infarction (heart attack). Flyrcado is a cyclotron-produced radioactive diagnostic drug for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise). Flyrcado is administered by intravenous injection. CAD is the narrowing or blockage of the coronary arteries, which supply oxygen-rich blood to the heart. It is often caused by plaque buildup in these arteries. CAD is very common, impacting over 18 million adults in the U.S., and is the leading cause of death in the U.S. #fda #heart #imaging #coronary #artery https://lnkd.in/gyxhNniR

The FDA, specifically OHT7, has been pointing companies to decision summaries that contain guidelines rather than issuing special control for IVDs that have been granted a de novo authorization. Today, they have released two FR notices classifying "Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens." Will a special controls document follow? medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and

#OnlineFirst w/ #PMT #JPharmTechnol this week, Cabanilla & colleagues with @UNMHSC compare vancomycin or daptomycin monotherapy versus dual therapy of either drug with ceftaroline in high-grade or persistent #MRSA bacteremia #pharmacists #infectiousdisease https://lnkd.in/ePXYSJvE

The FDA, the US drug regulatory authority, on March 22, 2024 approved the single-tablet macitentan/tadalafil combination (Opsynvi) for pulmonary arterial hypertension. The approval is based on the results of the Phase 3 A DUE study. Macintentan belongs to the class of drugs known as endothelin receptor antagonists and tadalafil to that of the PDE-5 inhibitors. Read more at this link. https://lnkd.in/d3-dASR4 #pulmonaryhypertension #pulmonaryarterialhypertension #PAH #chronicthromboembolicpulmonaryhypertension #CTEPH #knowledgesharing #knowledgeexchange #patientempowerment #patienteducation #allianceforph #organtransplant #organdonation #transplant #lungtransplant HTaPFrance Stichting Pulmonale Hypertensie / PH Association the Netherlands PH Belgium - Pulmonale Hypertensie vzw AIPI Italian Pulmonary Hypertension Association Pulmoner Hipertansiyon ve Skleroderma Hasta Dernegi Hellenic Community for Pulmonary Hypertension Pulmonale Hypertonie E.V. Ieva Plume Pulmonary Hypertension Knowledge Sharing Platform PHA Polska

Implementation of Supply-Related Restrictive Measures Reduces IVIG Use: Efforts include a mandatory intravenous immunoglobulin ordering form, blood bank gatekeeping, and a stewardship committee to ensure optimized use. #finance #pharmacy #lifesciences

#tbt Check out one of our past blogs covering Dostarlimab, which has since been FDA approved for use in 2023. #antibuddiesblog #antibuddiespodcast #sciencecommunication https://lnkd.in/gr3z7SRm

For those interested in a deep dive in what it takes to deliver an big idea from a research laboratory to the hands of patients, I strongly encourage you to read this fascinating story about Tzield, the first ever disease-modifying therapy to delay clinical (Insulin dependent) T1D. This is the first FDA approved drug EVER that addresses the cause of T1D, not just the symptoms. What an awesome story, over 38 years in the making.... #JDRF #Breakthoughs #T1D https://lnkd.in/gUA6Ti3H

The In Vitro Diagnostics (IVD) industry is quickly evolving, and understanding how sensitive a diagnostic is to moisture or oxygen can be a lot like playing a guessing game. This 1 simple question can take the guesswork out of IVD packaging. Do you know what it is? We break it down in this article.