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Submit Interim Safety, Efficacy Data: CDSCO Panel Tells Novartis on Crizanlizumab

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New Delhi: Reviewing the status of the ongoing studies of Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novartis to submit interim safety and efficacy data of ongoing Phase IV study in India along with periodic safety update report (PSUR) data in Indian population immediately to the authority. This came after the drug major Novartis presented the status of the ongoing studies with the product Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), in light of regulatory action by European Medicines Agency (EMA) on marketing authorization (MA) of the product Crinzalizumab(Adakveo), Crizanlizumab is a monoclonal antibody that targets selectin to reduce the frequency of vasooclusive crises in patients with sickle cell disease. Crizanlizumab is a humanized IgG2 monoclonal antibody used to reduce the frequenc...

Are all sugars equal? Study finds fruits score over honey, fruit juices, and sugar-sweetened beverages

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UK: In a recent study published in the European Journal of Nutrition, Javier T. Gonzalez, Department for Health, University of Bath, Bath, UK, sought to determine whether all sugars are equal. The study shed light on the role of the food source in physiological responses to sugars, emphasizing fruit and fruit juice. It found that adding whole fruit to the diet can lower markers of systemic inflammation, blood pressure, and body mass, and with substitution, can improve markers of glycemic control. "Therefore, from a cardiometabolic health standpoint, whole fruit can consistently and reliably improve markers of cardiometabolic health and are a cornerstone of a healthy dietary pattern," the study stated. Previous studies have shown that high (free) sugar consumption can increase self-reported energy intake and is associated with unfavorable cardiometabolic health. However, sugar sources may modulate the effects of sugars due to several mechanisms, including the food review...

Sulfur Cream Matches Triamcinolone in Treating Hand Eczema: Study

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Hand eczema (HE) is a common condition with diverse causes and symptoms. Various treatment options exist, including topical creams. Hand eczema presents with symptoms such as itching, dryness, burning sensation, and erythema, impacting patients' quality of life. Triamcinolone cream is a standard treatment, but sulfur cream's effectiveness remains uncertain. In this study, researchers compared the efficacy of triamcinolone 0.1% cream and sulfur 2% cream in treating Hand Eczema. Researchers have found that topical sulfur cream (2.0%) is equally effective as triamcinolone (0.1%) cream in treating Hand eczema. This study has been published in the Journal Of Cosmetic Dermatology by Asilian and colleagues. Researchers conducted a randomized, triple-blind clinical trial involving 70 patients with HE, treating both their right and left hands. Participants received either triamcinolone 0.1% cream or sulfur 2.0% cream twice daily for 4 weeks, with a 4-week follow-up period. Hand Ec...

Misleading Advertisement case: SC summons Baba Ramdev, MD Balkrishna for failing to reply to show-cause notice

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New Delhi: Expressing serious disappointment towards Patanjali Ayurved for neglecting to submit a response to its notice, the Supreme Court today issued a contempt notice to Baba Ramdev (Co-founder of Patanjali) and has summoned him along with its Managing Director Acharya Balakrishna to appear in court in person in the next hearing.  The court issued the directive while hearing the case, as the firm did not comply with a contempt notice related to Patanjali's breach of commitment to stop publishing misleading advertisements about medicinal cures. Clarifying that two weeks were given to Patanjali Ayurved and its MD for a response regarding the issue, the Bench comprising Justices Hima Kohli and Ahsanuddin Amanullah observed  "On the last date of hearing, notice to show cause was issued to the Respondent No. 5(Patanjali) and its Managing Director as to why the contempt of court proceedings should not be initiated against them...a period of two weeks was granted to file a re...

COVID-19 Vaccines Effectively Protect Individuals with Psychiatric Disorders: Study

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A recent study published in the Influenza Other Respiratory Viruses  journal examined the effectiveness of COVID-19 vaccines across various psychiatric disorders yielded promising outcomes. This study by Matthew Levy  and team from the VISION Network in four US determined if mental health conditions influence the efficacy of mRNA COVID-19 vaccines. The study encompassed data from a total of 2,436,999 adults from December 2021 to August 2022 and revealed that 22.1% of participants had at least one psychiatric disorder. Also, the individuals with psychiatric disorders expressed a higher incidence of COVID-19-related hospitalization compared to those without such conditions. Mood disorders, anxiety disorders and psychotic disorders were identified as significant independent predictors of hospitalization. Despite these increased risks, the mRNA vaccines demonstrated consistent effectiveness across all psychiatric disorder statuses. Among the patients with any psychiatric disord...

Dupilumab treatment may improve work productivity in patients with atopic dermatitis: Study

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Japan: A recent study published in Experimental Dermatology has shed light on the impact of 1-year treatment with dupilumab on work productivity in Japanese patients with atopic dermatitis (AD). The researchers showed that Dupilumab improved work productivity in Japanese patients with atopic dermatitis. They stated that long-term remission of pruritus and improved quality of life (QoL) are important for comprehensive improvement of work productivity. Atopic dermatitis (also called eczema) is a chronic (long-lasting) disease that causes redness, inflammation, and irritation of the skin. The condition places a burden on work productivity. Recently, dupilumab received approval for atopic dermatitis, but its impact on work productivity in Japanese patients has not been reported. Furthermore, data is limited on the effect of long-term treatment with dupilumab on work productivity. To fill this knowledge gap, Masahiro Kamata, Department of Dermatology, Teikyo University School of Medic...

Smoking associated with lower coronary volume–to–myocardial mass ratio, study shows

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Canada: A recent study published in Radiology: Cardiothoracic Imaging has suggested that current and former smoking status are independently associated with low coronary volume–to–myocardial mass ratio (V/M) on CT fractional flow reserve (CT-FFR). "Smoking is associated with lower coronary volume-to-myocardial mass ratio in individuals with coronary artery disease (CAD)," the researchers reported. The findings further cement the link between smoking and heart disease. Current and former smoking were independently associated with lower V/M in participants with coronary artery disease, the researchers noted. Previous studies have shown that a low volume-to-myocardial mass ratio is associated with conditions such as hypertrophic cardiomyopathy microvascular angina, and coronary artery disease, with greater stenosis. However, the effect of smoking volume-to-myocardial mass ratio has not been thoroughly established. To fill this knowledge gap, Kenneth R. Holmes, University o...