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Mylan Waives Exclusive U.S. Distribution Rights for Potential COVID-19 Therapy

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pharmaceuticals

U.S. drugmaker Mylan NV said it had waived its exclusive U.S. distribution rights to its generic version of HIV treatment Kaletra, which is currently being tested against the coronavirus. The move would make other drugmakers eligible to seek U.S. approval for their generic versions of the drug and boost supply, which would help in case…

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Risk Factors for Death From COVID-19 Identified in Wuhan Patients

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Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use…

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United States Lags Behind Other Countries in Home Dialysis

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dialysis

The push for home dialysis in the United States is taking on a new urgency in the backdrop of COVID-19, according to nephrologist Christopher Chan, MD, head of the division of nephrology at University Health Network (UHN) in Toronto. The first two patients in the United States known to have died from COVID-19 were outpatients…

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FDA Adds Boxed Warning to Montelukast Over Mental Health Risks

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The US Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair), which is used to treat asthma and allergy. The agency will add a boxed warning to montelukast advising healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, according…

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Japan Confirms First Case of Infection With New China Coronavirus

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TOKYO – Japan confirmed the first case of infection from the new China coronavirus that has killed one person and prompted a travel alert from the U.S. State Department. A man in his 30s from Kanagawa prefecture, next to Tokyo, tested positive, Japan’s health ministry said in a statement on Thursday. The man had been…

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FDA Clears Faster Diagnostic Test for MRSA

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gdmeds news about MRSA (Methicillin-resistant Staphylococcus aureus infection) on the table with stethoscope, medical concept

The US Food and Drug Administration (FDA) has approved a new, faster diagnostic test based on bacterial viability and a novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a common cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test, from Roche Molecular Systems, may allow healthcare providers to evaluate patients for colonization with MRSA bacteria…

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FDA Clears Next-Gen Assay to Detect HIV-1 Drug Resistance Mutations

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The US Food and Drug Administration (FDA) has approved the Sentosa SQ HIV genotyping assay (Vela Diagnostics USA Inc) that uses next generation sequencing technology to detect HIV-1 drug resistance mutations from a blood sample. Recent data suggest that the percentage of people living with HIV around the world that have resistance to some HIV drugs has…

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