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Showing posts from September, 2024

NEJM: Results from targeted therapy for ulcerative colitis study

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An international placebo-controlled study led by Cedars-Sinai suggests that a targeted drug therapy that was developed by researchers at Cedars-Sinai is safe and effective at helping people with moderate to severe ulcerative colitis reach clinical remission. Results from the multicenter Phase II study, ARTEMIS-UC, were published in The New England Journal of Medicine. Ulcerative colitis is a type of inflammatory bowel disease (IBD) that damages the digestive tract, causing stomach cramping, diarrhea, weight loss and rectal bleeding. It affects as many as 900,000 people in the U.S., and current treatments are often only minimally effective. “Findings from this study are poised to have a remarkable impact on treatment for ulcerative colitis and IBD overall,” said study senior author and IBD research pioneer Stephan Targan, MD, the Feintech Family Chair in Inflammatory Bowel Disease and executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai. “The inv...

Eris Lifscience Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

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New Delhi: Reviewing the bioequivalence (BE) study report of the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Gliclazide plus Metformin Hydrochloride film-coated bilayer tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Eris Lifesciences to manufacture and market the proposed antidiabetic drug. However, this approval is subject to the condition of conducting the Phase IV clinical trial of the proposed FDC. This nod came after the firm presented a BE study report of Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg/10mg + Gliclazide IP (SR) 30mg/60mg + Metformin Hydrochloride IP (SR) 500mg/500mg film-coated bilayered tablet before the committee. Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin is indicated as an adjunct treatment, alongside diet and exercise, ...

ICMR calls for Research Proposal for North Eastern Region fellowships, grants 2024-2025, check details

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New Delhi- Through a recent notice, the Indian Council of Medical Research (ICMR), New Delhi has called for Research Proposals for only North Eastern Region Fellowships/Grants for the Year 2024-2025 under the ''Human Resource Development (IHRD) Scheme for Health Research" of the Department of Health Research (MoHFW) in the emerging fields of Medical/Clinical/Health Sciences. The Human Resource Development Scheme aims to provide opportunities for advanced training 111 biomedical and health research for creating a pool of trained & experienced human resources in India. Also Read:ICMR Calls For Research Proposals for 2024-2025, All Details Here The following Component of the Scheme Online research proposals are invited for the year 2024-2: from eligible applicants from North Eastern States (Arunachal Pradesh, Assam, Mampt:1 - , Meghalaya, Mizoram, Nagaland, Sikkim, Tripura): Short-term Fellowship at Indian Institute (1-3 months) Long Term Fellow...

PGI Chandigarh's SFC meeting Rescheduled for October 6

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Chandigarh: The 130th standing Finance Committee (SFC) meeting of the Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh has been rescheduled to October 6, 2024, due to Health Minister JP Nadda’s attendance at the nursing institute NINE’s convocation. The specific time and venue for the meeting have yet to be finalized.  The upcoming SFC is scheduled to address important issues, including manpower allocation for doctors’ security. This issue has gained urgency in light of recent assaults on healthcare professionals, highlighting the need for enhanced protective measures. It’s worth noting that the 129th SFC meeting was delayed and only took place after being postponed five times. Also Read:Kolkata doctor death case: AIIMS Doctors demand Central Protection Act, Strike continues The State Finance Commission (SFC) meeting is poised to focus on the urgent need for additional workforce resources to enhance security and safety on campus. This initiative re...

Hospitals Not Paid Despite Release of Funds Under Ayushman Bharat: HC Attaches Salary of State Health Secretary among Others

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Chandigarh:  While considering the pleas filed by several hospitals in Punjab seeking the release of pending dues from the State Government under the Ayushman Bharat Scheme, the Punjab and Haryana High Court till October 16, attached the salaries of senior officials, including the Principal Secretary of the Health Department of the State, for failing to release the pending dues. "Let an affidavit be filed by the State Government of Punjab giving the details of the payments that have been made against bills since 30.12.2021 to 24.09.2024 alongwith the date on which such payment was released, within a period of two weeks from today. The salaries of Kumar Rahul, IAS, Principal Secretary, Department of Health, Ms. Babita, Chief Executive Officer, Mr. Deepak, Director and Ms. Sharanjit Kaur, Deputy Director, State Health Agency, Department of Health and Family Welfare, Punjab shall remain attached till the next date of hearing," ordered the HC bench. "This Court also tent...

Pure & Cure Healthcare gets CDSCO Panel nod to study Ferric Maltol Capsules 30 mg

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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Pure and Cure Healthcare to conduct the bio-equivalence study of Ferric Maltol Capsules 30 mg as per the protocol presented. This came after the firm presented the proposal for grant of permission to manufacture and market of Ferric Maltol Capsules 30 mg along with bioequivalence study protocol (No. VRL-23-004, Ver-1.0, dated: 01.09.2023 and Phase III clinical trial waiver justification before the committee. Ferric maltol is a complex iron supplement used to treat iron deficiency in adults. Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it is associated with transferrin and ferritin. At the recent SEC meeting for Hematology held on September 10, 2024, the expert panel reviewed the...

Rare Case of Retinopathy Linked to Hair Dye Aromatic Amines, Study: JAMA

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Retinopathy associated with the use of hair dye aromatic amines (RAHDAA) is a rare form of retinopathy that is caused due to the use of hair dye. Recently researchers identified this in three individuals. The case findings were published in the journal JAMA Ophthalmology. A rare form of retinopathy, associated with the use of hair dyes containing aromatic amines (RAHDAA), has recently been reported in three middle-aged women that presented with multiple bilateral serous retinal detachments (SRDs), resembling MEK inhibitor-associated retinopathy, and appears to be linked to the disruption of the mitogen-activated protein kinase (MAPK) pathway. Discontinuation of the hair dye led to resolution of retinopathy within months.  Also Read:  Bilirubinemia May Protect Against Severe Retinopathy of Prematurity in Extremely Preterm Infants: Study One case was a 61-year-old woman without any significant medical history, developed bilateral blurry vision shortly after using a hair dye...

Tranexamic acid may help control GI bleeding, prevent rebleeding in cirrhosis patients: Study

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Tranexamic acid may help control GI bleeding, and prevent rebleeding in cirrhosis patients suggests a study published in the Hepatology. Patients with Child-Turcotte-Pugh class B and C cirrhosis with upper gastrointestinal bleeding (UGIB) have systemic as well as localized (in the mucosa of the esophagus and stomach) fibrinolysis. The aim of this study was to evaluate the efficacy and safety of tranexamic acid in the treatment of acute UGIB in patients with cirrhosis. A total of 600 patients with advanced liver cirrhosis (Child-Turcotte-Pugh class B or C) presenting with UGIB were randomly allocated to either the tranexamic acid (n=300) or the placebo group (n=300). The primary outcome measure was the proportion of patients developing 5-day treatment failure. Failure to control bleeding by day 5 was seen in 19/300 (6.3%) patients in the tranexamic acid group and 40/300 (13.3%) patients in the placebo group (p=0.006). Esophageal endoscopic variceal ligation (EVL) site as a source of ...

Ziresovir Shows Promise in Alleviating Bronchiolitis Symptoms in Hospitalized Infants with RSV: Study

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China: In a promising development for pediatric care, a recent study has highlighted the efficacy of Ziresovir in treating infants hospitalized due to respiratory syncytial virus (RSV) infection. The research, published in the New England Journal of Medicine, provides vital insights into managing bronchiolitis, a common respiratory condition that can lead to severe complications in young children. The researchers found that treatment with Ziresovir, an antiviral medication, significantly alleviated the signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection, with no safety concerns reported. Respiratory syncytial virus (RSV) is a major cause of serious illness in infants, and currently, there is no effective treatment available. However, results from a phase 2 trial indicate that ziresovir may be an effective option for treating infants hospitalized with RSV infection. Against the above background, Xin Ni, Beijing Children’s Hospital, Bei...

Semaglutide associated with lower opioid overdoses in people OUD and type 2 diabetes: JAMA

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Since being deemed a public health emergency in 2017, opioids are responsible for 72% of drug overdose deaths in the United States, according to the National Center for Drug Abuse Statistics. New research from the Case Western Reserve University School of Medicine identifies a potential new approach to address the opioid overdose epidemic—which has devastated families and communities nationally. The study, published today in the journal JAMA Network Open,  suggests semaglutide is linked to lower opioid overdoses in people with opioid-use disorder (OUD) and type 2 diabetes (T2D). Semaglutide, a glucagon-like peptide receptor (GLP-1R) molecule that decreases hunger and helps regulate blood sugar in T2D, is also the active component in the diabetes and weight-loss drugs Wegovy and Ozempic. The research team-led by biomedical informatics professor Rong Xu-analyzed six years of electronic records of nearly 33,000 patients with OUD who also had T2D. The researchers used a statistica...

5 formulations declared as spurious including Sun Pharma's Ursocol 300, Glenmark's Telma H

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New Delhi: In the latest spurious drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has declared 5 formulations to be spurious, adulterated, or misbranded for August 2024, which includes some commonly prescribed medicines, including Sun Pharmaceuticals' Pulmosil (Sildenafil Injection), Sunpharma laboratories' Pantocid (Pantoprazole Tablets IP) and Ursocol 300 (Ursodeoxycholic Acid Tablets IP), Glenmark's Telma H (Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP), and Macleods' Defcort 6 Tablets (Deflazacort). The medication samples failed due to a number of reasons, including issues with the assay, identification test, particle matter, volume in the container, sterility, and description. In response to the alert mentioned above, a statement was issued by Sun Pharmaceuticals, Sunpharma Laboratories, Glenmark Pharmaceuticals, and Macleods Pharmaceuticals, which said, " The actual manufacturer (as per ...

Diabetes may Impair Exercise Capacity in Heart Failure Patients, Study Finds

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Germany: A propensity score-matched study has unveiled a concerning association between diabetes mellitus and diminished exercise capacity in patients with heart failure (HF). This research, which utilized a propensity score-matched design to account for various confounding factors, highlights the specific challenges that diabetic patients face in managing their heart failure. "Most predictors of reduced exercise capacity in heart failure are consistent across patients, regardless of diabetes. However, impaired vascular function and lower HDL cholesterol specifically predict decreased exercise capacity only in individuals with diabetes," the researchers wrote in Diabetes Research and Clinical Practice. Exercise intolerance is a key feature of heart failure, significantly impacting quality of life and associated with higher mortality. Patients with HF experience greater declines in physical function compared to those with other chronic diseases. Diabetes, prevalent in 45% ...

Torsemide, Dapagliflozin FDC not rational: CDSCO Panel Rejects Syngene's Proposal for BA/BE study

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New Delhi: Noting the proposed fixed-dose combination (FDC) of 24 mg extended-release (ER) Torsemide and 8 mg Dapagliflozin Tablets is not rational; the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected Syngene's request to conduct the bioavailability/bioequivalence (BA/BE) studies. This came after the firm presented the Protocol No.: SYNCD-022-24, Version No. 1.00, Date 12-APR-2024 for BA/BE study for export purposes only. Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. Torasemide is a diuretic used to treat hypertension and edema associated with heart failure, renal failure, or liver disease. Torasemide is indicated for the treatment of edema associated with congestive heart failure, and renal or hepatic diseases. Torasemide is also approved to be used as an antihypertensive agent either alone or in combination with other antihypertensiv...

Research Finds Higher Rates of Precocious Puberty in Children with Hidradenitis Suppurativa

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USA: A recent study found that the prevalence of early-onset puberty was significantly higher in children with hidradenitis suppurativa (HS) compared to those without the condition, indicating that precocious puberty more than doubles the likelihood of developing HS. The findings were published online in JAMA Dermatology.  Hidradenitis suppurativa, a chronic inflammatory skin disorder characterized by painful nodules and abscesses, primarily affects areas of the body where skin rubs together, such as the armpits and groin. The condition is particularly challenging for younger patients, as it can impact both physical health and emotional well-being. Sex hormones play a significant role in the onset and activity of hidradenitis suppurativa. Exploring the connections between HS and disorders related to sex hormones could enhance the understanding of HS pathophysiology and inform treatment strategies. Prior research has established associations between HS and androgen-related disor...

Sex-Specific Differences Observed in Lipoprotein(a) Levels to Predict Coronary Artery Disease in new study

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A recent study from the Koc University Hospital revealed crucial insights into the relationship between lipoprotein(a) [Lp(a)] levels and the risk of coronary artery disease (CAD), with notable differences based on sex. The study published in the journal of Clinical Cardiology was set out to clarify the inconsistent findings from earlier research by examining how Lp(a) levels influence CAD risk in men and women separately. Lp(a) is a well-established risk factor for coronary artery disease. However, there has been ongoing debate about whether the association between elevated Lp(a) levels and CAD differs between men and women. This study wanted to settle the question by analyzing Lp(a) levels in a large cohort of patients and exploring whether sex-specific differences exist in the Lp(a)-CAD relationship. The study analyzed data from a total of 1,858 patients admitted to the tertiary care facility at Koc University Hospital. With an average age of 54 years, 53.33% of the patients wer...

Proposed risk factor tool finds heart failure rates higher among American Indian adults

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The incidence rate of heart failure was 2- to 3-fold higher among American Indian populations than rates observed in studies focused on other population groups, such as African American, Hispanic or white adults, in a new study published today in the   Journal of the American Heart Association, an open access, peer-reviewed journal of theAmerican Heart Association. The results were calculated using a new, proposed risk prediction scale for heart failure specifically for American Indian adults. The analysis also found smoking, Type 2 diabetes status, kidney damage, previous heart attack and high blood pressure are major modifiable determinants of developing heart failure over 5 to 10 years among American Indian adults. “Implementation of our proposed risk prediction scale in clinical practice can contribute to optimized risk assessment and to the development of preventive strategies to reduce heart failure events and deaths in American Indian communities and populations with a ...

Bariatric surgery outperforms GLP-1 diabetes drugs for kidney protection suggests Cleveland Clinic study

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A Cleveland Clinic study showed that in patients with type 2 diabetes, obesity, and chronic kidney disease, bariatric surgery was associated with a significant decrease in the progression of chronic kidney disease compared to those who received GLP-1 diabetes medications. The paper was published in Annals of Surgery. According to the Centers for Disease Control and Prevention, more than 1 in 7 U.S. adults are estimated to have chronic kidney disease, which can lead to renal failure. Chronic kidney disease is the longstanding disease of the kidneys which can lead to renal failure. Kidneys filter waste through the blood. As kidneys begin to fail, that waste can build up. Some patients need dialysis, which filters the blood through a machine. Ali Aminian, M.D., lead author of the study and director of Cleveland Clinic’s Bariatric & Metabolic Institute, said, “Our study shows that bariatric surgery can protect the kidneys and prevent the worsening of kidney function. In patients wit...

Non-prescription anti-redness regimens effective in reducing facial redness in patients with rosacea, finds study

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Non-prescription anti-redness regimens are effective in reducing facial redness in patients with rosacea finds a study published in the Journal of Drugs in Dermatology. The treatment of rosacea is complicated as multiple pathogenic factors in play result in a myriad of clinical signs and symptoms including facial redness. The primary objective was to evaluate the efficacy and tolerability of a non-prescription anti-redness regimen in patients with rosacea. Thirty subjects with rosacea-induced facial erythema were enrolled in this single-site, monadic study. The test regimen consisted of a treatment serum, redness-reducing moisturizer, and sunscreen. The test products are formulated with ingredients curated to address the multifactorial pathogenesis of facial redness. Investigator and subject self-assessment for efficacy and tolerability were performed at baseline, weeks 4 and 8. Non-invasive assessments for facial redness and skin hydration were conducted at all time points. Results...

ESMO: Combination therapy reduced agitated delirium in patients with advanced cancers

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Treatment with a combination of haloperidol and lorazepam reduced symptoms of agitated delirium, a common end-of-life condition for patients with advanced cancers, compared with haloperidol alone, according to a new study led by researchers at The University of Texas MD Anderson Cancer Center. The findings were presented today at the 2024 European Society for Medical Oncology (ESMO) Congress. Agitated delirium occurs when a patient’s brain function begins to deteriorate as their cancer advances, resulting in many patients beginning to behave aggressively or abnormally. Although the use of medication in this setting has been debated, these results suggest tailored combination treatments can significantly improve symptoms for patients at the end of life. “Advanced delirium is common and highly distressing in many patients with advanced cancers receiving palliative care, but we’ve had limited evidence on the use and effectiveness of treatment for this condition,” said lead investigator...

Two-dose schedule could make HIV vaccines more effective, reports research

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One major reason why it has been difficult to develop an effective HIV vaccine is that the virus mutates very rapidly, allowing it to evade the antibody response generated by vaccines. Several years ago, MIT researchers showed that administering a series of escalating doses of an HIV vaccine over a two-week period could help overcome a part of that challenge by generating larger quantities of neutralizing antibodies. However, a multidose vaccine regimen administered over a short time is not practical for mass vaccination campaigns. In a new study, the researchers have now found that they can achieve a similar immune response with just two doses, given one week apart. The first dose, which is much smaller, prepares the immune system to respond more powerfully to the second, larger dose. This study, which was performed by bringing together computational modeling and experiments in mice, used an HIV envelope protein as the vaccine. A single-dose version of this vaccine is now in clini...

CDSCO Implements Online System for Veterinary Drug Applications on SUGAM Portal

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New Delhi: In a significant move to streamline the regulatory submission procedure, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Veterinary Division, has announced that all applications for new veterinary drug and vaccine permissions will now be processed exclusively through the online SUGAM Portal. The notice states, "In order to streamline the regulatory submission procedure, the submission of application for issuance of New Drug permission of Vaccines/ Drugs for Bulk (API) in Form-45A/46A and finished formulation in Form-45/46 and Field Trial Permission is now functiohial on online system ofSUGAM Portal (www.cdscoonline.gov.in)." SUGAM is an online e-governance portal introduced by the government of India to build an in-depth regulatory framework for the registration processes of the CDSCO. This site, which has already been used by pharmaceutical companies for human drugs, will now be the primary platform for handli...