Powered by WPeMatico
Mumbai: Cipla has received six inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) at the conclusion of a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of the Company located in Patalganga, Maharashtra, India.
The inspection was held from 28th March 2024 to 4th April 2024.
“The
Company will work closely with the USFDA and is committed to address these comprehensively within the
stipulated time,” Cipla stated.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Read also: Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. Khwaja Abdul Hamied founded the Company in 1935 in Mumbai. Cipla has extended its presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. The Company is also deepening its presence in the key markets of India, South Africa, and the U.S. among other economies of the emerging world.
Read also: Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler
Powered by WPeMatico
New Delhi: The Supreme Court has directed the National Medical Commission (NMC) to submit the details of the stipend paid to MBBS interns in all the medical colleges across all States within four weeks.
While considering the allegation of non-payment of stipend to MBBS interns in 70 percent of the medical colleges in the country, the Apex Court bench referred to its earlier order dated 15.09.2023, through which NMC was told to respond to the claim by filing an affidavit giving a tabulated chart of colleges which were paying the stipend to the interns and which were not paying.
Noting that the details submitted by NMC were not of all the medical colleges across all the States, the Apex Court bench comprising Justices Sudhanshhu Dhulia and Prasanna Bhalachandra Varale ordered on April 01, 2024, “The details which have been given by the National Medical Commission is not of the entire medical colleges in the States and therefore, the direction given by this Court in its order dated 15.09.2023 at para 10 had not been complied with. Let the same be done positively within a period of four weeks from today.”
Meanwhile, the top court bench directed the petitioner to file a rejoinder to the counter affidavit already filed by National Medical Commission. The matter has been listed for further hearing on 06.05.2023.
Medical Dialogues had earlier reported that the Supreme Court bench had taken cognisance of the issue while considering a plea filed by five MBBS students studying at Army College of Medical Sciences (ACMS) affiliated with Guru Govind Singh Indraprastha University seeking a stipend for the period of internship.
While considering the plea filed by ACMS students, the top court bench had directed the medical college to start paying its Interns Rs 25,000 per month from October 1, 2023. During the hearing of the case, the counsel for the students Advocate Vaibhav Gagghar informed the bench that a recent NMC report stated that 70 per cent of the medical colleges in the country were not paying stipends to their interns.
Taking note of this, the bench had directed the National Medical Commission’s counsel Advocate Gaurav Sharma to respond to the claim and file an affidavit.
“Mr Gaurav Sharma, counsel appearing for the National Medical Commission shall file a tabulated chart and explain (i) whether the statement which has been made to the above effect is correct; and (ii) what steps the National Medical Commission is taking to ensure compliance with the norms for payment of internship stipends,” the bench had ordered on 15.09.2023.
At the previous hearing, the top court bench had expressed concern over the fact that even after charging crores of rupees for the MBBS course, the medical colleges were not adequately paying stipends to the MBBS interns. “What kind of medical colleges are they? They are charging one crore, I do not know how much they are charging for postgraduate students and they are not prepared to give the stipend also,” the top court bench comprising Justice Sudhanshu Dhulia and Prasanna B Varale had observed.
“Either you pay them, or you don’t have the internship,” Justice Dhulia had earlier observed.
Meanwhile, during the hearing of the matter on April 1, lawyer Tanvi Dubey, appearing for a group of doctors, informed the bench that the foreign medical graduates in certain medical colleges are not being paid stipends during their internships.
Taking note of this, the Supreme Court said that the FMGs cannot be treated differently and should be paid stipends during their internship like their counterparts who have done MBBS from Indian medical colleges.
To view the Supreme Court order, click on the link below:
https://medicaldialogues.in/pdf_upload/supreme-court-mbbs-stipend-235633.pdf
Also Read: Supreme Court relief: FMGs to now get stipend during internship as Indian MBBS interns
Powered by WPeMatico
Srinagar: To ensure patient care at government hospitals, the Jammu and Kashmir Health Department issued an order on Monday for Prof (Dr) Iffat Hassan Shah, the Principal of Government Medical College Handwara, to assume the additional responsibility of being the Principal of Government Medical College (GMC) Srinagar.
The appointment was made as per the order, considering the retirement of Dr Masood Tanveer Bhat, the principal of GMC Srinagar, who retired on April 31st.
“Consequent upon the superannuation of Prof. (Dr.) Masood Tanvir Bhat, Principal GMC Srinagar on 31-03-2024, and due to the Model Code of Conduct being in place because of General Elections to Lok Sabha – 2024 and to ensure patient care in Government Medical College, Srinagar & Associated Hospitals, it is hereby ordered that Prof. (Dr.) Iffat Hassan I/c Principal Government Medical College Handwara shall look after the charge of Principal Government Medical College Srinagar, in addition to her duties, till further orders,” reads the order.
Also read- West Bengal: Paediatrician Dr Kaustav Nayek Takes Charge As New DME
In response to the government order, Dr Iffat confirmed her joining at GMC Srinagar as the principal through an official order.
“In pursuance of Government Order No: 257-JK(HME) of 2024 Dated. 01.04.2024 issued under Endst. No: ME-Gztd/255/2022 (CC: 7029004) Dated. 01.04.2024 I, Prof. (Dr.) Iffat Hassan Shah, I/C Principal Govt. Medical College, Handwara assume the charge of Principal, Government Medical College, Srinagar today on 01.04.2024 (A.N) in addition to my own duties,” stated the order.
Dr Iffat Hassan completed her MD in Dermatology, Venereology and Leprosy from PGI Chandigarh. She has been the HOD of the Dermatology Department at GMC Srinagar since 2011.
She is the recipient of Prof K Sidappa Gold Medal for an Original research paper in Guwahati in January 1997, Young Scientists Award for the year 2000 by J&K Science and Technology department, Howard Maibach Award 2014 (American Contact Dermatitis Society) at Denver, USA, IADVL Oration at DERMACON 2018 at Kochi in January 2018 and many more.
Moreover, she is the author of “Colour Atlas and Clinical Synopsis of Skin Tumours” and a “ Comprehensive Textbook of Psoriasis”. Served as the President of Contact and Occupational Dermatoses Forum of India (CODFI) from 2017-2019 and Indian Association of Dermatologists,Venereologists and Leprologists J&K Branch from 2017-2018.
Also read- Lt Gen Ashok Kumar Jindal Appointed As New Executive Director And CEO Of AIIMS Raipur
Powered by WPeMatico
Post-stroke depression (PSD) is a common complication affecting stroke survivors, but data on its long-term course and recurrence rates are limited. A recent prospective study from the U.K. provides valuable insights into the incidence and recurrence of PSD over an 18-year period, highlighting the importance of routine depression screening in stroke survivors. This study was published in the journal of Lancet Regional Health – Europe. The study was conducted by Liu L. and colleagues.
PSD can have significant implications for the recovery and quality of life of stroke survivors, yet it often goes unrecognized and untreated. Understanding the timing and recurrence patterns of depression following stroke is crucial for implementing effective interventions and support strategies.
Researchers analyzed data from the South London Stroke Register, including 3,864 stroke survivors assessed for depression over 18 years. Depression was measured using the Hospital Anxiety and Depression Scale, and patients were followed up to assess recurrence rates and long-term outcomes.
The key findings of the study were:
• The cumulative incidence of PSD over 18 years was 59.4%, with 87.9% of cases occurring within the first 5 years post-stroke.
• Within 3 months, 33.4% of PSD cases were identified, increasing to 54.6% within 1 year.
• Recurrence of depression was common, with 66.7% of patients experiencing recurrence, predominantly within 5 years of recovery.
• Patients with severe depression had lower recovery rates and higher recurrence rates compared to those with mild depression.
• Routine screening for depression within 5 years post-stroke is recommended, as depression can begin as early as 3 months post-stroke.
The study highlights the significant burden of PSD in stroke survivors and underscores the need for long-term monitoring and support. Early detection and intervention for depression can improve outcomes and enhance the overall well-being of stroke survivors.
Post-stroke depression is prevalent, with the majority of cases occurring within the first 5 years post-stroke. Routine screening for depression in stroke survivors is crucial for timely identification and management of this common complication. Long-term follow-up and support are essential to address the high recurrence rates observed in this population.
Reference:
Liu L, et al “Natural history of depression up to 18 years after stroke: a population-based South London Stroke Register study” Lancet Reg Health Eur 2024; DOI: 10. 1016/j.lanepe.2024. 100882.
Powered by WPeMatico
Even people whose physical activity levels fall short of recommended guidelines, but who manage to do some during their leisure time, are likely to have a lower risk of stroke than their sedentary peers, suggests a pooled data analysis of the available evidence, published online in the Journal of Neurology Neurosurgery & Psychiatry.
The effects are independent of age and sex, the findings show, prompting the authors to suggest that everyone should be encouraged to do whatever level of physical activity they can manage in their leisure time.
There’s no doubt that moderate to high levels of leisure-time physical activity curb stroke risk. But it’s not clear if even modest amounts confer protection, and if any such effects depend on age and sex, explain the authors.
While international guidelines recommend 150 minutes or more a week of moderate intensity physical activity or 75 minutes or more of vigorous intensity activity to lower the risk of cardiovascular disease, including stroke, not many adults achieve this, say the researchers.
To find out if lower levels of physical activity might still confer protection, the authors trawled research databases for relevant studies. They pooled the results of 15, involving 752,050 adults whose health had been monitored for an average of 10.5 years.
Each study assessed the potential impact of between 3-none, below target, and ideal-and 5-none, insufficient, low, moderate and intense-levels of leisure time physical activity on stroke risk.
The pooled data analysis of 5 studies assessing 3 levels of leisure time physical activity showed that, compared with no physical activity, the highest ‘ideal’ amount cut the risk of stroke by 29%, but that some ‘below target’ activity still reduced the risk by 18%.
Similar findings emerged for the pooled data analysis of the six studies reporting on 4, and the two reporting on 5 levels of leisure time physical activity. Compared with none, a moderate level of physical activity cut the risk of stroke by between 27% and 29%.
These effects were independent of sex and age, the analysis showed.
The authors acknowledge several limitations to their findings, chief among which were the variable definitions of different levels of activity used in the included studies and the reliance on subjectively assessed levels of physical activity.
Nevertheless, the authors conclude that recreational physical activity, even in small amounts could help ward off stroke in the long term.
“According to our results, all levels of [leisure time physical activity] can be beneficial for stroke prevention, including levels currently regarded as low or insufficient,” they write. “People should be encouraged to be physically active even at the lowest levels.”
Reference:
De Santis F, Romoli M, Foschi M, et alRisk of stroke with different levels of leisure-time physical activity: a systematic review and meta-analysis of prospective cohort studiesJournal of Neurology, Neurosurgery & Psychiatry Published Online First: 05 March 2024. doi: 10.1136/jnnp-2023-332457.
Powered by WPeMatico
A new study found
that Monosodium urate (MSU) crystal deposits,
detectable with dual-energy CT (DECT), diminish rapidly during pegloticase
treatment, particularly when co-administered with methotrexate (MTX) for
uncontrolled gout. The volume of MSU crystals also slowed or stopped
even when SU was maintained at <6mg/dL with oral ULT.
The study findings were published in the journal Joint Bone Spine.
Monosodium urate (MSU) crystal deposits can be observed and measured
using dual-energy CT (DECT). Pegloticase effectively reduces serum urate (SU)
levels in uncontrolled gout patients, often with methotrexate (MTX) co-therapy
to enhance response and mitigate infusion reactions. However, limited
literature exists on DECT imaging during pegloticase+MTX treatment. Hence,
researchers conducted a study to address this gap by presenting DECT findings
from a larger cohort in a randomized controlled trial, investigating bone
erosion remodeling following MSU depletion with pegloticase therapy, and
exploring the impact of treatment duration. During the MIRROR RCT trial, patients were administered either
pegloticase (8mg every 2 weeks) along with methotrexate (MTX) orally at a dose
of 15mg/week, or pegloticase with a placebo (PBO).
A subgroup underwent DECT
imaging on Day 1 (the initial pegloticase infusion) and at Weeks 14, 24, and
52. Patients with paired baseline-Week 52 images were analyzed. Regions with
baseline MSU-crystal volume (VMSU) <0.5cm3 were excluded to minimize
artifact contributions. VMSU and bone erosion remodeling were evaluated.
Results:
Thus, the study concluded a swift reduction in monosodium urate (MSU) crystal volume
(VMSU) during pegloticase therapy, accompanied by concurrent bone remodeling
within a year. However, upon discontinuation of pegloticase, the rate of VMSU
reduction decelerated or halted, despite maintaining serum urate (SU) levels
below 6mg/dL with oral urate-lowering therapy (ULT).
Further reading: Examination of monosodium urate
crystal depletion and bone erosion remodeling during pegloticase treatment in
patients with uncontrolled gout: exploratory dual-energy computed tomography
findings from MIRROR RCT. Doi: https://doi.org/10.1016/j.jbspin.2024.105715
Powered by WPeMatico
The US Food and Drug Administration has approved injectable drug ceftobiprole medocaril sodium (Zevtera) for treatment of Staphylococcus aureus bacteremia (SAB) among adults. Ceftobiprole, a pyrrolidinone cephalosporin antibiotic, is active moiety of the prodrug ceftobiprole medocaril.
It is indicated for people with right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 3 months to less than 18 years old.
“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”
Zevtera’s efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects). The primary measure of efficacy for this trial was the overall success (defined as survival, symptom improvement, S. aureus bacteremia bloodstream clearance, no new S. aureus bacteremia complications and no use of other potentially effective antibiotics) at the post-treatment evaluation visit, which occurred 70 days after being randomly assigned an antibiotic. A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.
Zevtera’s efficacy in treating ABSSSI was evaluated in a randomized, controlled, double-blind, multinational trial. In the trial, researchers randomly assigned 679 subjects to receive either Zevtera (335 subjects) or vancomycin plus aztreonam [the comparator] (344 subjects). The primary measure of efficacy was early clinical response 48-72 hours after start of treatment. Early clinical response required a reduction of the primary skin lesion by at least 20%, survival for at least 72 hours and the absence of additional antibacterial treatment or unplanned surgery. Of the subjects who received Zevtera, 91.3% achieved an early clinical response within the necessary timeframe compared to 88.1% of subjects who received the comparator.
Zevtera’s efficacy in treating adult patients with CABP was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. In the trial, researchers randomly assigned 638 adults hospitalized with CABP and requiring IV antibacterial treatment for at least 3 days to receive either Zevtera (314 subjects) or ceftriaxone with optional linezolid [the comparator] (324 subjects). The primary measurement of efficacy were clinical cure rates at test-of-cure visit, which occurred 7-14 days after end-of-treatment. Of the subjects who received Zevtera, 76.4% achieved clinical cure compared to 79.3% of subjects who received the comparator. An additional analysis considered an earlier timepoint of clinical success at Day 3, which was 71% in patients receiving Zevtera and 71.1% in patients receiving the comparator.
Given the similar course of CABP in adults and pediatric patients, today’s approval of Zevtera in pediatric patients three months to less than 18 years with CABP was supported by evidence from the CABP trial of Zevtera in adults and a trial in 138 pediatric subjects three months to less than 18 years of age with pneumonia.
For adults with SAB, the most common side effects of Zevtera included anemia, nausea, low levels of potassium in the blood (hypokalemia), vomiting, diarrhea, increased levels of certain liver tests (hepatic enzymes and bilirubin), increased blood creatinine, high blood pressure, low white blood cell count (leukopenia), fever, abdominal pain, fungal infection, headache and shortness of breath (dyspnea).
For adults with ABSSSI, the most common side effects of Zevtera included nausea, diarrhea, headache, injection site reaction, increased levels of hepatic enzymes, rash, vomiting and altered taste (dysgeusia).
For adults with CABP, the most common side effects of Zevtera included nausea, increased levels of hepatic enzymes, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, vein inflammation (phlebitis), high blood pressure and dizziness. For pediatric patients with CABP, the most common side effects of Zevtera included vomiting, headache, increased levels of hepatic enzymes, diarrhea, infusion site reaction, vein inflammation (phlebitis) and fever.
Patients should not use Zevtera if they have a known history of severe hypersensitivity to ceftobiprole or any of the components of Zevtera, or other members of the cephalosporin antibacterial class.
Zevtera comes with certain warnings and precautions such as increased mortality in ventilator-associated bacterial pneumonia patients (an unapproved use), hypersensitivity reactions, seizures and other central nervous system reactions and Clostridioides difficile-associated diarrhea.
Zevtera was granted Priority Review, Fast Track and Qualified Infectious Disease Product designations for the CABP, ABSSSI and SAB indications.
The FDA granted the approval of Zevtera to Basilea Pharmaceutica International Ltd.
Powered by WPeMatico
USA: Using an electronic health record (EHR)-based algorithm plus practice facilitators embedded in primary care clinics did not reduce hospitalization at one year, according to a pragmatic trial involving patients with the triad of chronic kidney disease, hypertension, and type 2 diabetes.
“The hospitalization rate of patients in the intervention group at one year was about the same as that with usual care (20.7% vs 21.1%),” the researchers reported in the ICD-Pieces study published in the New England Journal of Medicine.
Patients with chronic kidney disease (CKD), type 2 diabetes (T2D), and hypertension (the kidney-dysfunction triad) are at high risk for multiple complications, end-stage kidney disease, and premature death. Despite the availability of effective therapies for these patients, there is a lack of results of large-scale trials examining the implementation of guideline-directed therapy to reduce death and complications risk in this population.
Miguel Vazquez, the University of Texas Southwestern Medical Center in Dallas, and colleagues conducted an open-label, cluster-randomized trial including 11,182 patients with the kidney-dysfunction triad being treated at 141 primary care clinics. They were assigned to receive an intervention that used a personalized algorithm (based on the patient’s EHR) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care.
The study’s primary outcome was hospitalization for any cause at 1 year. Secondary outcomes were readmissions, emergency department visits, dialysis, cardiovascular events, and death. Cardiovascular events included heart failure, acute coronary syndrome, and stroke, while cardiovascular procedures included cardiac catheterization and revascularization.
The researchers assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group.
The researchers reported the following findings:
While the intervention missed the mark for reducing hospitalizations, Vazquez highlighted the importance of improving care for patients with the kidney-dysfunction triad.
“In this pragmatic trial involving patients with the kidney-dysfunction triad, using an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year,” the researchers concluded.
Reference:
Vazquez MA, et al “Pragmatic trial of hospitalization rate in chronic kidney disease” N Engl J Med 2024; DOI: 10.1056/NEJMoa2311708.
Powered by WPeMatico
Bariatric surgery may result in significant cardiometabolic improvements, particularly among younger, female, or white people and those without comorbidities, according to new research published in the Journal of the Endocrine Society.
The United States has the highest obesity rates globally. In 2017-2018, about 40% of U.S. adults had obesity and 9% had severe obesity. The prevalence is particularly high among Black adults. Bariatric surgery is one method to help people with severe obesity lose a lot of weight and improve their health.
“Our study highlights how bariatric surgery not only leads to significant weight loss but also substantially improves heart health,” said study author Lei Wang, M.Phil., of Vanderbilt University Medical Center in Nashville, Tenn. “These health benefits include lower blood pressure, blood lipids and blood sugar, and an estimated 35% reduction in 10-year cardiovascular disease risk one year after surgery.”
“Additionally, 30% to 50% of people in our study experienced remissions of diabetes, hypertension and dyslipidemia,” added co-author Danxia Yu, Ph.D., of Vanderbilt University Medical Center. “Individuals who were younger, female, self-identified as white and had no history of cardiometabolic diseases tended to see greater post-surgery cardiometabolic improvements.”
The researchers analyzed over 7,800 people between the ages of 20 to 79 who underwent bariatric surgery during 1999-2022 at the Vanderbilt University Medical Center. Most study participants were women and white, but the study also includes a significant number of male patients and Black patients, who have been underrepresented in bariatric surgery research.
The researchers evaluated various cardiometabolic improvements, including blood pressure, cholesterol, glucose and HbA1c. They also measured remission rates of diabetes, hypertension and dyslipidemia, and the estimated 10-year cardiovascular disease risk.
Older, male or Black patients showed less reduction in 10-year heart disease risk and lower odds of diabetes, hypertension and dyslipidemia remission than younger, female or white patients. Patients with a history of diabetes, hypertension, dyslipidemia or cardiovascular disease showed less cardiometabolic improvements than those without.
“Our findings can help people with severe obesity experience better health outcomes and help us recognize which patients may require extra health management after surgery,” Wang said.
Reference:
Lei Wang, Michael T O’Brien, Xinmeng Zhang, You Chen, Wayne J English, Brandon Williams, Matthew Spann, Vance Albaugh, Xiao-Ou Shu, Charles R Flynn, Danxia Yu, Cardiometabolic Improvements After Metabolic Surgery and Related Presurgery Factors, Journal of the Endocrine Society, Volume 8, Issue 5, May 2024, bvae027, https://doi.org/10.1210/jendso/bvae027.
Powered by WPeMatico
