Category: News
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New triple antiviral drug combination for treating COVID-19 in phase 2 randomized trial
A two-week course of antiviral therapy with interferon beta-1b plus lopinavir-ritonavir and ribavirin, started within 7 days of showing COVID-19 symptoms, is safe and more effective at reducing the duration of viral shedding than lopinavir-ritonavir alone in patients with mild to moderate illness, according to the first randomised trial of this triple combination therapy involving…
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Veeva to Deliver End-to-End Safety Signal and Risk Management
Veeva Systems (NYSE: VEEV) today announced Veeva Vault Signal, the industry’s first solution that seamlessly manages signals from identification through risk evaluation and mitigation. Vault Signal unifies signal management processes so pharmacovigilance teams can easily manage safety signals with greater visibility across the entire signal workflow. Together with Vault Safety, Vault SafetyDocs, and Vault Safety.AI, Veeva offers the only comprehensive…
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COVID-19 vaccine update
Phase 2/3 vaccine: Organizations: University of Melbourne and Murdoch Children’s Research Institute (Australia); Radboud University Medical Center (The Netherlands); Faustman Lab at Massachusetts General Hospital (MGH) (United States)Vaccine candidate: Bacillus Calmette-Guerin (BCG) live-attenuated vaccine for COVID-19Original indication: Tuberculosis (TB) pediatric vaccineDetails: The BCG vaccine has been implicated in helping to combat other infections outside TB by boosting the immune system to fight similar infections.…
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New Zealand Government is planning to put folic acid in bread
Consumer NZ supports putting folic acid in non-organic bread-making flour – saying it “balances consumer choice” with reducing devastating birth defects. The non-profit also wants an education campaign to make sure women know they must also take folic acid supplements before conception and in early pregnancy. The Government is again considering making it mandatory for…
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ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs
The International Council for Harmonisation (ICH) on Tuesday adopted its S11 guideline on nonclinical safety testing to support the development of pediatric drugs following consultations by its regulatory members last year. This guidance is also for products with prior adult use, as well as products being considered for initial human use in paediatrics ICH says…
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FDA warning to sellers of Miracle Mineral Solution
The U.S. Food and Drug Administration has issued a warning letter to a seller that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19). The FDA has previously warned consumers not to purchase or drink chlorine dioxide products sold online as medical treatments, as the agency…
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Novartis planning to initiate clinical study of Jakavi in severe COVID-19 patients and establish international compassionate use program
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved in 101 countries for the different indications including treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with…
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Falsified HIV rapid diagnostic test circulating in Guyana and Kenya
WHO was informed that at least 8,240 falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at end-user level. The product is Uni-Gold™ HIV and claims to be manufactured by Trinity Biotech plc. Subsequent reports revealed that the same falsified product is also circulating in Kenya. Uni-Gold™ HIV is a single-use rapid diagnostic…
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Paediatric labeling updates for doxycycline, clindamycin and caffeine citrate
Drug labels for doxycycline, clindamycin and caffeine citrate now include better information for healthcare providers on recommended usage and dosage in pediatric populations. The data that informed these label changes came from research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. Doxycycline is…
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FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia, an oral medication taken once daily, is the only approved sphingosine-1-phosphate (S1P) receptor…