Alzheimer’s drug may slow down cognitive decline in dementia with Lewy bodies: Study

Dementia with Lewy bodies is a type of dementia that is similar to both Alzheimer’s disease and Parkinson’s disease but studies on long-term treatments are lacking. A new study from Karolinska Institutet in Sweden, published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, highlights the potential cognitive benefits of cholinesterase inhibitor treatment.

Lewy body disease, which includes dementia with Lewy bodies (DLB) and Parkinson’s disease with and without dementia, is the second most common neurodegenerative disorder, following Alzheimer’s disease. DLB accounts for approximately 10–15 per cent of dementia cases and is characterised by changes in sleep, behaviour, cognition, movement, and regulation of automatic bodily functions.

“There are currently no approved treatments for DLB, so doctors often use drugs for Alzheimer’s disease, such as cholinesterase inhibitors and memantine, for symptom relief,” says Hong Xu, assistant professor at the Department of Neurobiology, Care Sciences and Society, Karolinska Institutet and first author of the paper. “However, the effectiveness of these treatments remains uncertain due to inconsistent trial results and limited long-term data.”

In the current study, researchers have examined the long-term effects of cholinesterase inhibitors (ChEIs) and memantine compared with no treatment for up to ten years in 1,095 patients with DLB. They found that ChEIs may slow down cognitive decline over five years compared to memantine or no treatment. ChEIs were also associated with a reduced risk of death in the first year after diagnosis.

“Our results highlight the potential benefits of ChEIs for patients with DLB and support updating treatment guidelines,” says Maria Eriksdotter, professor at the Department of Neurobiology, Care Sciences and Society, Karolinska Institutet and last author of the paper.

Due to the study’s observational nature, no conclusions can be drawn about causality. The researchers did not have data on patient lifestyle habits, frailty, blood pressure, and Alzheimer’s disease co-pathology, which may have influenced the findings. Another limitation of the study is that it remains challenging to diagnose DLB accurately.

Reference:

Hong Xu, Annegret Habich, Daniel Ferreira, Londos Elisabet, Eric Westman, Maria Eriksdotter, Long-term effects of cholinesterase inhibitors and memantine on cognitive decline, cardiovascular events, and mortality in dementia with Lewy bodies: An up to 10-year follow-up study, Alzheimer s & Dementia, https://doi.org/10.1002/alz.14118.

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Breakthrough in Menopause Treatment: Elinzanetant Cuts Hot Flashes and Enhances Sleep, New Trials Reveal

USA: Recent findings from the OASIS 1 and OASIS 2 randomized clinical trials highlight the potential of Elinzanetant as a significant advancement in treating vasomotor symptoms (VMS) associated with menopause. The trials, which involved evaluating Elinzanetant’s efficacy and safety, have demonstrated that this novel treatment could offer substantial relief for women experiencing moderate to severe menopausal symptoms.

In two pivotal Phase 3 clinical trials, Elinzanetant showed statistically significant reductions in the frequency and severity of vasomotor symptoms compared to placebo. Additionally, Elinzanetant notably improved sleep disturbances and menopause-related quality of life while maintaining a favorable safety profile. The findings were published online in JAMA.

Elinzanetant, a selective neurokinin-1,3 receptor antagonist, targets key pathways to regulate body temperature and mood, providing a new option for managing menopause-related vasomotor symptoms such as hot flashes and night sweats. These symptoms can significantly impact the quality of life, affecting daily activities and sleep patterns.

Considering the need for safe and effective nonhormonal treatments for menopausal VMS, JoAnn V. Pinkerton, University of Virginia Health, Charlottesville, and colleagues aimed to evaluate the safety and efficacy of elinzanetant for the treatment of moderate to severe menopausal vasomotor symptoms.

Two randomized, double-blind Phase 3 trials, OASIS 1 and OASIS 2, evaluated the efficacy of Elinzanetant in postmenopausal women aged 40 to 65 years with moderate to severe vasomotor symptoms. OASIS 1 was conducted at 77 sites across the US, Europe, and Israel from August 27, 2021, to November 27, 2023, while OASIS 2 took place at 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023. Participants received either 120 mg of oral Elinzanetant daily for 26 weeks or a matching placebo for 12 weeks, followed by 14 weeks of Elinzanetant.

The primary outcomes assessed were the mean changes in the frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, as recorded in the electronic hot flash daily diary. Secondary outcomes included changes in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and the Menopause-Specific Quality of Life questionnaire total score from baseline to week 12.

The researchers reported the following findings:

  • Eligible participants (mean age, OASIS 1: 54.6 years; OASIS 2: 54.6 years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). 78.0% and 81.0% completed OASIS 1 and 2, respectively.
  • For the elinzanetant and placebo groups, the baseline mean VMS per 24 hours was 13.4 versus 14.3 (OASIS 1) and 14.7 versus 16.2 (OASIS 2).
  • Baseline VMS severity was 2.6 versus 2.5 (OASIS 1) and 2.5 versus 2.5 (OASIS 2).
  • Elinzanetant significantly reduced VMS frequency at week 4 (OASIS 1: −3.3; OASIS 2: −3.0) and week 12 (OASIS 1: −3.2; OASIS 2: −3.2).
  • Elinzanetant also improved VMS severity at week 4 (OASIS 1: −0.3; OASIS 2: −0.2) and week 12 (OASIS 1: −0.4; OASIS 2: −0.3).
  • Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable.

“Elinzanetant offers the potential as a well-tolerated and effective nonhormonal treatment to meet the unmet needs of many menopausal individuals suffering from moderate to severe vasomotor symptoms,” the researchers concluded.

Reference:

Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. Published online August 22, 2024. doi:10.1001/jama.2024.14618

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Pivotal study supports belzutifan approval for patients with advanced kidney cancer

Belzutifan is a hypoxia-inducible factor 2α inhibitor that has showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies.

The LITESPARK-005 phase 3 clinical enrolled 746 patients with metastatic clear cell renal cell carcinoma (ccRCC) who had progressed after treatment with both an immune checkpoint inhibitor (ICI) and an anti-angiogenic therapy. Patients were randomized to receive treatment with either belzutifan, a HIF-2α inhibitor, or everolimus. Overabundant HIF-2α is associated with increased cancer-driving activity.

At the second interim analysis of this study, after a median of 25.7 months, patients taking belzutifan were 25% less likely to have progressed compared with those taking everolimus. Results were presented at the annual European Society for Medical Oncology (ESMO) Congress in 2023 and are now published in the New England Journal of Medicine.

Belzutifan showed a significant benefit over everolimus with respect to progression-free survival and objective response in participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies. Belzutifan was associated with no new safety signals.

At the second interim analysis (median follow-up, 25.7 months), the median overall survival was 21.4 months in the belzutifan group and 18.1 months in the everolimus group; at 18 months, 55.2% and 50.6% of the participants, respectively, were alive (hazard ratio for death, 0.88; 95% CI, 0.73 to 1.07; two-sided P=0.20, which did not meet the prespecified significance criterion). Grade 3 or higher adverse events of any cause occurred in 61.8% of the participants in the belzutifan group (grade 5 in 3.5%) and in 62.5% in the everolimus group (grade 5 in 5.3%).

Based on the evidence from this randomized, active-controlled trial, belzutifan was approved by the U.S. Food and Drug Administration for adult patients with advanced renal cell carcinoma (RCC) following standard treatment with an ICI or anti-angiogenic therapy. This approval of a HIF-2α inhibitor meets a need for drugs with novel therapeutic mechanisms in advanced renal cell carcinoma.

Reference:

Toni K. Choueiri, Thomas Powles, Katriina Peltola, Guillermo de Velasco, Mauricio Burotto, Cristina Suarez, Pooja Ghatalia, Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma, New England Journal of Medicine, DOI: 10.1056/NEJMoa2313906.

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Higher Aspirin Dose May Reduce Preeclampsia Risk in High-Risk Obese Pregnant Women, unravels study

A recent randomized trial published in the American Journal of Obstetrics and Gynecology unveiled that a higher dose of aspirin may reduce the risk of preeclampsia (PE) with severe features in high-risk obese pregnant women. Preeclampsia is characterized by high blood pressure and signs of damage to other organ systems, often affects the pregnant women. This in turn can lead to serious complications for both mother and baby. Preventive measures, including the use of low-dose aspirin, have been recommended to reduce these risks. However, recent data have raised concerns about the adequacy of the 81 mg dose, particularly in obese women, who may experience aspirin resistance by potentially diminishing the efficacy of drugs.

The study compared the efficacy of 162 mg of aspirin daily to the standard 81 mg dose, which is currently recommended by leading medical societies in the US for women at risk of PE. The study included a total of 220 participants between May 2019 and November 2022 with a body mass index (BMI) of 30 kg/m² or higher and at least one additional high-risk factor like a history of PE in a prior pregnancy, stage I hypertension, or diabetes diagnosed before 20 weeks of gestation. 

The study wanted to evaluate whether the administration of 162 mg of aspirin would be more effective than 81 mg in reducing the incidence of PE with severe features. The participants were randomly assigned to one of the two aspirin dosage groups and were monitored from 12 to 20 weeks of gestation until delivery. The study excluded women with multifetal gestation, known major fetal anomalies, or existing conditions like seizure disorders or baseline proteinuria.

The results of this study showed that 35% of the women in the 162 mg group developed PE with severe features when compared to 40% in the 81 mg group. Although the difference was not statistically significant, the Bayesian analysis indicated a 78% probability that the higher dose would reduce the risk of severe PE. The best estimate suggests a 12% reduction in the incidence of PE with severe features when using 162 mg of aspirin compared to 81 mg.

Secondary outcomes, including rates of preterm birth due to preeclampsia, small for gestational age (SGA), placental abruption, and postpartum hemorrhage, were similar between the two groups. Adverse effects related to the medication were also comparable which indicated that the higher dose did not increase the risk of complications in the participants. Overall, the findings of this study highlight the potential benefits of a higher aspirin dose in preventing severe preeclampsia in high-risk obese women.

Reference:

Amro, F. H., Blackwell, S. C., Pedroza, C., Backley, S., Bitar, G., Daye, N., Bartal, M. F., Chauhan, S. P., & Sibai, B. M. (2024). Aspirin 162 mg versus 81 mg for Preeclampsia Prophylaxis in High-risk Obese Individuals: A Comparative Effectiveness Open Label Randomized Trial (ASPREO). In American Journal of Obstetrics and Gynecology. Elsevier BV. https://doi.org/10.1016/j.ajog.2024.06.038

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Dr Reddy’s Laboratories gets CDSCO Panel nod to study Live Attenuated Varicella Vaccine

New Delhi: Dr. Reddy’s Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of the Live Attenuated Varicella Vaccine to evaluate the immunogenicity and safety of the Varicella Vaccine (BARYCELA) in a healthy pediatric population 12 months to 12 years of age.

However, this nod came in line with the condition that the firm should conduct immunogenicity analysis for all proposed 500 evaluable subjects in part 2 of the trial, with age stratification for all proposed age groups.

This took place following the firm’s presentation of the revised Phase III clinical trial protocol for the Live Attenuated Varicella Vaccine study titled “A Phase III, multicentre, randomized, observer-blind, active-controlled, parallel group, non-inferiority study to evaluate immunogenicity and safety of Varicella vaccine (BARYCELA) in Healthy Pediatric Population 12 months to 12 years of age”.

Chickenpox, or varicella, is a contagious disease caused by the varicella-zoster virus (VZV). The virus is responsible for chickenpox (usually the primary infection in non-immune hosts) and herpes zoster or shingles (following reactivation of latent infection). The Live Attenuated Varicella Vaccine is indicated for the prevention of varicella in children aged 12 months to 12 years of age.

BARYCELA inj., Live Attenuated Varicella Vaccine, is a white lyophilized formulation for injection contained in a colorless and transparent vial that appears as a colorless or light-yellow liquid when dissolved with the enclosed solvent, sterile Water For Injection (WFI).

The vaccine is administered subcutaneously, and it is presented in a 2 mL glass vial of Borosilicate, EP Type Ⅰ clear glass, with a pharmaceutical grade rubber stopper made out of butyl rubber and a cap made of aluminium-plastic combinations.

Earlier, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) had opined Dr. Reddy’s Laboratories to revise the protocol for varicella vaccine (BARYCELA) by including a safety cohort of a total of 100 subjects in the higher age group of the 12 months to 12 years age group with a test and control arm and completing a complete safety study with DSMB (Data and Safety Monitoring Board) review before initiation of the immunogenicity and safety study in the targeted age group.

In continuation, at the recent SEC meeting for vaccine held on August 22, 2024, the expert panel reviewed the revised Phase III clinical trial protocol of the Live Attenuated Varicella Vaccine study titled “A Phase III, multicentre, randomized, observer-blind, active-controlled, parallel-group, non-inferiority study to evaluate the immunogenicity and safety of Varicella vaccine (BARYCELA) in Healthy Pediatric Population 12 months to 12 years of age”.

After detailed deliberation, the committee recommended the approval of the presented Phase-III clinical trial protocol with the condition of conducting immunogenicity analysis for all proposed 500 evaluable subjects in Part 2 of the trial with age stratification for all proposed age groups.

Accordingly, the expert panel suggested that the revised protocol should be submitted to CDSCO for further approval.

Also Read: MSN Laboratories gets CDSCO Panel nod to conduct Bioequivalence Study of Abiraterone Tablets1000mg

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KGMU releases revised guidelines for starting, running PDCC and Fellowship courses, details

Lucknow- Through as recent notice King George’s Medical University (KGMU), Lucknow released revised guidelines for starting and managing PDCC/Fellowship courses.

All the concerned stakeholders seeking to run PDCC and Fellowship courses in King George’s Medical University (KGMU), Lucknow are advised to take note of the following guidelines:

Following the
approval of the Executive Council on 15th June 2024 and based on the minutes of the
Academic Council meeting held on 09th January 2024 (Agenda No. 03), and in light
of the report submitted by the review committee chaired by the Pro-Vice Chancellor,
the revised guidelines for starting and managing PDCC/Fellowship courses are to be
implemented immediately, stated the KGMU

The revised guidelines are outlined below:

A. For starting the
new PDCC/Fellowship courses:

  1. Departments can start PDCC/Fellowship courses only on 20% of allotted
    seats of Senior Residents (Un-Registered) in Broad Specialties and 30% of allotted
    seats of Senior Residents (Un-Registered) in Super Specialties. If the already
    existing PDCC/Fellowship seats sanctioned in the department are above the 20%
    (Broad Specialty) and 30% (Super Specialty) then the department will not be
    permitted to start the new PDCC/Fellowship course.
  2. Next criteria for calculating the number of PDCC/Fellowship course seats
    will be based on number of available faculty and JRs (MDIMS)/SRs (DMIMCH) in
    the department. Total number of MD/MS/DM/MCH seats plus PDCC/Fellowship seats
    cannot
    exceed the number of NMC, New Delhi eligibility criteria for teacher/student ratio. If number of
    sanctioned JRs/SRs seats are equivalent to availability of PG Teachers as per National Medical
    Commission, New Delhi criteria, then PDCC/Fellowship
    seats can be sanctioned only against the number of available faculty on the post of Assistant Professor in the
    department.

For example, if
department have Professor-1, Associate Professor- I and Assistant Professor-2 and
department already have 5 sanctioned seats of MDIMS/DM/MCH then the department
can take only 2 PDCC/Fellowship seats against 02 Assistant Professor who will
supervise these students under the guidance of PG a teacher.

  1. Department must justify the needs of these
    courses. PDCC/Fellowship courses will not be permitted in those subjects, in which
    MDIMS/DM/MCH courses are already running.
  2. PDCC/Fellowship should be proposed only in “Niche area” of the
    subject, for example areas/subjects in which MDIMSIMCHIDM courses are already running,
    there
    is no use of starting PDCC/Fellowships in those subjects. However, PDCC courses already
    running in various departments will continue.
  3. The courses be reviewed every 05 years and reappraisal should be done
    with the approval of Hon’ble Vice-Chancellor.
  4. Self sponsored seats should not be allowed.
  5. PDCC/Fellowship courses which are already running and passed froM Board
    of Faculty of Medicine, Academic Council and Executive Council will
    continue, as per rules and regulations of this University.
  6. It was also instructed to take mankikaran GO into account for starting
    new seats of PDCC.

Also Read:KGMU notifies on workshop organised by IISE Lucknow, Science-Tech Institute, Faculties, residents can participate

B. For running sanctioned
PDCC/Fellowship courses:

  1. Self sponsored seats shall not be allowed.
  2. Departments having no seats for Senior Residents (lin-Registered) should
    enroll only against sanctioned sponsored candidates seats.
  3. Head of Department and course coordinator will supervise the
    PDCC/Fellowship Course and he will be responsible for the teaching and training of the
    students. Head of department will yearly monitor the progress of
    PDCC/Fellowship Course.
  4. No separate Entrance Examination will be held for PDCC/Fellowship
    Courses. The successful candidates of Senior Resident (Un-registered) entrance
    examination will be offered PDCC/Fellowship course as per the merit obtained by them, in
    the aforesaid exam, in the respective department. Senior Residents
    (Un-registered) appointed through bond will have to appear in the same entrance
    examination for admission in PDCC/Fellowship courses. Sponsored Candidates will also
    appear in the same examination for admission in the PDCC/Fellowship courses.
  5. The candidates have to secure minimum 50% marks in the entrance
    examination to become eligible for admission in PDCC/Fellowship course.
  6. University fee (admission and Exit Examination fee) will be paid by all
    the candidates including sponsored candidates.
  7. Rules and regulation of PDCC/Fellowship course decided by the
    Dean-Academics vide
    Order no. Dean M/KGMU/2019/613 Dated 16th July 2019 will be followed
    except point no. 11 of the rules and
    regulation.

The Salary/Stipend
of Sponsored candidates for PDCC/Fellowship Courses will be paid by his/her
employer/sponsoring institute. A document in support will be required from employer/sponsoring institute. An
affidavit shall also be submitted by the sponsored candidates stating therein that the salary/stipend will be paid by
his/her employer/sponsoring institute
and KGMU will not be responsible for his/her Salary/stipend, the notice read.

This
order is effective immediately and must be adhered to for all current and future
PDCC/Fellowship courses, the KGMU said.

Also Read:KGMU Announces SOP for MD, MS, MDS Admissions Through NEET PG 2024

To view the guidelines click the link below

https://medicaldialogues.in/pdf_upload/kgmu-22-249096.pdf

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JJ Hospital Dean Dr Pallavi Saple joins SC-formed National Task Force for Hospital Security

Mumbai: Dr Pallavi
Saple, Dean of the JJ Group of Hospitals, has been selected as the sole
representative from Maharashtra in the National Task Force for Hospital Security, established by the Supreme Court on Monday.

Dr Saple, a 51-year-old
paediatrician, made history in 2019 when she became the youngest dean of the
state-run hospital since Independence. She oversees the JJ campus, which spans
48 acres.

Also Read:JJ Hospital struggles to maintain Digital Healthcare Management Information System

A distinguished alumna of
JJ Hospital’s Grant Medical College and the daughter of a dental surgeon, Dr Saple has built an impressive career. Until recently, she also served as the
administrator of the Maharashtra Medical Council, the body responsible for
upholding medical ethics in the state. Her contributions have been recognized
at various levels, including her participation in a state-level committee
probing alleged malpractices at Pune’s Sassoon General Hospital following the
Porsche car crash case involving two doctors, reports the Daily.

In light of ongoing
concerns about hospital security, Dr Saple informed the Times of India of the
government’s plans to enhance safety measures on the JJ Hospital campus,
especially amid recent strikes by resident doctors. The hospital, which has not
experienced any major violent incidents in recent years, faces security
challenges due to its large campus and multiple entry points. Currently, the
hospital employs 179 security guards and operates 667 CCTV cameras, with plans
to increase these numbers by adding 150 guards and 600 cameras. 

Also Read:JJ Hospital Dean Dr Pallavi Saple appointed as new administrator of Maharashtra Medical Council

The Supreme Court’s task
force, to which Dr. Saple has been appointed, is expected to submit an interim
report within three weeks and a final report within two months. This task force
aims to bolster security measures across hospitals nationwide, ensuring the
safety of both medical professionals and patients.

Dr Saple also served as
the head of the Government Medical College in Miraj for three years. She
graduated from Grant Medical College and was attached to JJ Hospital in 1995. She
pursued her post-graduation before joining as a faculty in 1999. She was promoted to associate professor before finally becoming the dean of the institute.

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Sahyadri Hospitals MomStory successfully treats newborn with severe Chikungunya

Pune: Sahyadri Hospitals MomStory is proud to announce the successful treatment of a newborn who developed severe complications due to a Chikungunya (CHIKV) infection shortly after birth.  

This case highlights the intricate challenges of managing mosquito-borne diseases in newborns, especially during transitional seasons when such infections are more prevalent.

The newborn was initially delivered in good health and discharged three days after a normal delivery. However, just six days later, the infant was readmitted to Sahyadri Hospitals MomStory Nagar Road hospital with symptoms that were both alarming and confusing.

The baby presented with a high fever, refused to feed, showed minimal activity, and had developed a noticeable body rash. Given the recent surge in Dengue cases within Pune, the medical team initially suspected Dengue. However, after conducting the necessary tests, Dengue was ruled out, leaving the medical team to explore other potential causes.

Also Read:Sahyadri Hospital perform Unique Contrast-Free Angioplasty on 62-year-old man

The situation took a critical turn on the third day of the infant’s readmission when the baby experienced convulsions. The medical team responded immediately, administering anticonvulsant medications to stabilize the newborn. An EEG was conducted, which confirmed seizure activity, further raising concerns about the severity of the condition. To understand the underlying cause, a lumbar puncture was performed, and an MRI was conducted, both of which revealed signs of a brain infection. Concurrently, the baby’s platelet count began to drop significantly, prompting the doctors to conduct a comprehensive tropical fever panel test. This test ultimately confirmed the presence of the Chikungunya virus.

To ensure the accuracy of the diagnosis and to rule out congenital transmission (infection passed from mother to baby during pregnancy or childbirth), the medical team also tested the mother’s antibodies. The results were negative, confirming that the baby had acquired the infection after birth, which added another layer of complexity to the case.

The Chikungunya infection in this newborn led to a range of serious complications, including liver dysfunction, issues with blood coagulation, and respiratory difficulties. The infant was placed on respiratory support to manage breathing difficulties and was given intravenous immunoglobulins to reduce the inflammation that had spread throughout the body. The medical team at Sahyadri closely monitored the baby’s condition, adjusting treatments as needed to address the various complications that arose.

After 17 days in the Intensive Care Unit (ICU), the baby’s condition began to show signs of improvement. The liver function started to normalize, the platelet count stabilized, and the newborn’s overall health began to recover. Thanks to the relentless efforts and expertise of the medical team at Sahyadri Hospitals MomStory, which included Dr Preeti Lad, Dr Prateek Katariya, Dr Nikita Mankar, Dr Sushmita, and Dr Dinesh Thakare, under the leadership of Dr Pradeep Suryawanshi, the baby was eventually discharged in good health.

Dr Pradeep Suryawanshi, Director & HOD, Neonatology and Pediatrics at Sahyadri Hospitals MomStory, expressed his relief and satisfaction with the outcome. He commented, “This case truly underscores the importance of comprehensive and timely diagnostic evaluations in newborns. The varied symptoms presented by the baby required a thorough and methodical approach to identify the Chikungunya infection. Our team’s ability to quickly respond to the evolving condition and manage the complications was crucial to the baby’s recovery. It was incredibly rewarding to see the baby discharged in a healthy state after such a challenging journey.”

Sahyadri Hospitals MomStory remains steadfast in its commitment to providing high-quality, specialized care for newborns and all its patients. This case is a testament to the hospital’s dedication to managing even the most complex medical challenges with expertise, compassion and care.

Also Read:Sahyadri Hospital doctors perform laparoscopic cystectomy to treat rare ovarian condition in 13-year-old girl

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Lupin bags Health Canada nod for biosimilar Pegfilgrastim

Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from Health Canada for its biosimilar Pegfilgrastim. This product will be marketed under the brand name Armlupeg and manufactured at Lupin’s Biotech facility at Pune, India.

Armlupeg (pegfilgrastim) is a biosimilar comparable to the reference biologic drug NEULASTA (pegfilgrastim). Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim. Pegfilgrastim prefilled syringes are indicated to decrease the incidence of infection, as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Armlupeg is available in a form of pre-filled syringe of 6mg/0.6 ml.

Nilesh Gupta, Managing Director, Lupin said, “We are committed to providing affordable and high-quality treatment to our patients. The Health Canada approval for Armlupeg strengthens our ability to support Canadian patients with this mainstay treatment.”

Read also: Lupin alliance partner ForDoz gets USFDA nod for Doxorubicin Hydrochloride Liposome Injection

Dr. Cyrus Karkaria, President, Biotech Division said, “Biosimilars play an important role providing access to cancer treatment and supportive care. We are happy to receive our second biosimilar approval in Canada and look forward to maintaining this momentum with additional launches in regulated markets.”

Read also: Lupin, Huons ink pact for registration, marketing of Cyclosporine Ophthalmic Nanoemulsion in Mexico

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally. Lupin subsidiaries are Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Read also: Lupin secures USFDA tentative nod for Brimonidine Tartrate Ophthalmic Solution

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Himachal Pradesh: Resident doctors to work for 12 hours

Shimla: Amid the widespread protest by doctors over the brutal rape and murder of a PG medico at RG Kar Medical College, the Himachal Pradesh Health Department has declared that the resident doctors at all government medical colleges across the state will work for 12 hours a day including on-call duties. 

Assuring that the doctors would no longer have to work overtime, the state health department issued an order to the Director of Medical Education and Research, in this regard. 

The order issued on August 21 mentioned “The matter was examined at the government level and it was decided the duty hours of resident doctors must not exceed 12 hours per day, including the on-call duty.”

Also read- 28 percent MBBS, 15 percent PG medical students diagnosed with mental health issues: NMC Survey

This comes in response to the long-standing demands of resident doctors who have been complaining about working for 24 to 36 hours nonstop which hampered their mental health leading to distress due to continuous workload. 

During the protest aimed primarily at seeking justice for the deceased PG doctor, the resident doctors from most of the medical colleges also raised their voices for their unstable working hours and the need for a centralised law for medical professional security including installation of CCTV and more. 

Following this, the Himachal Pradesh government issued a new directive in this regard. The order mandates that the principals of these medical colleges adjust the duty rosters to reflect the new guidelines. Additionally, the colleges are required to submit a compliance report to the government within a week, as reported by The News Himachal report. 

Apart from this, the order also mentioned that the shift of resident doctors will end before 7:00 pm considering their security amid the circumstances in the nation following the brutal death of PG trainee doctors at RG Kar Hospital. 

This new directive will bring major relief to resident doctors of government medical colleges across the state and dental medical colleges as well. 

Commenting on this, a resident doctor told the Daily, “This system was centuries old, and changing it will bring much-needed relief. The mental burden due to excessive work will also be significantly reduced.”

Medical Dialogues had earlier reported that the half-naked body of the deceased RG Kar PG Respiratory Medicine medico was recovered from the seminar hall of the hospital on Friday morning. A preliminary autopsy report has indicated sexual abuse before she was killed.

As per the inquest report, there was bleeding from the doctor’s eyes and mouth, injury on the face and nails, bleeding from her genitals, and several other injury marks on different parts of her body. Soon after the news of this horrific incident came to light, doctors in Bengal and across the country started a massive protest demanding justice.

Also read- No more than 74 hours work per week, 24 hours at stretch by Resident Doctors: NMC

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