NIRF 2024: Thiruvananthapuram GMC ranks 6 among Govt Medical Colleges In India

Thiruvananthapuram- The Government Medical College (GMC) and Dental College, Thiruvananthapuram have once again ranked among the top 50 in the National Institutional Ranking Framework (NIRF) rankings.

Government Medical College, Thiruvananthapuram has secured 42nd rank with 52.30 marks in the top 50 medical institutions released by NIRF under the Ministry of Education. Similarly, the Government Dental College here has secured the 21st position in the NIRF ranking in the dental colleges category with a score of 53.91.’

Moreover, Thiruvananthapuram GMC is ranked 6th among all government medical colleges in India, and Government Dental College, Thiruvananthapuram is ranked 5th among government dental colleges in the country. With this, Thiruvananthapuram GMC is also the only government medical college from Kerala to make it to the top 50 rankings by the NIRF.

The rankings of the top Dental Colleges and top medical colleges across India were recently disclosed in a press conference by Union Education Minister Dharmendra Pradhan.

As per the NIRF rankings, among all the dental colleges in India, Saveetha Institute of Medical and Technical Sciences, Tamil Nadu has been ranked number 1 with a score of 81.83. Colleges in Tamil Nadu, Delhi, Karnataka, Uttar Pradesh, Maharashtra and Orrisa have been able to get into the top 10 in the list of NIRF ranking 2024.

Meanwhile, among all the medical colleges across India, the All India Institute of Medical Sciences (AIIMS), New Delhi has been ranked number 1 across India with a score of 94.46. All India Institute of Medical Sciences (AIIMS), New Delhi occupies the top slot in medicine for the seventh consecutive year, i.e. from 2018 to 2024. Moreover, AIIMS is ranked in 7th position in the Overall category. It was ranked in 6th position in the Overall category in 2023.

Medical Colleges in Delhi, Chandigarh, Tamil Nadu, Karnataka. Pondicherry and Uttar Pradesh have been able to get into the top 10 in the list of NIRF ranking 2024.

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NMC asks medical colleges to integrate Yoga in medicos’ Lives to Promote Mental Health

New Delhi: In its Report of the National Task Force on Mental Health and Well-being of Medical Students, the National Medical Commission (NMC), has recommended that medical colleges integrate yoga into students’ lives by organising regular classes and seminars and also include it in the curriculum to reduce stress, prevent mental illness and develop resilience.

According to the online survey conducted by a National Medical Commission (NMC) task force, around 28 per cent of MBBS and 15.3 per cent of PG medical students reported having been diagnosed with mental health conditions.

NMC Anti-Ragging Committee had set up the National Task Force to study existing literature and data on the mental health of medical students and propose evidence-based strategies for improving the same.

This Task Force had initiated an online survey, collecting data from medical students, faculties, and administrators regarding mental health history, workload, overall stress level, etc. More than 37,000 medical students had submitted their responses to the government authorities, indicating that they were suffering from mental stress.

After analyzing the data collected from the in-person visit to the medical colleges, the online survey, and the meeting with stakeholders, the Task Force noted that mental health conditions have been diagnosed in 7,115 (27.7%) students, with 3,780 (14.8%) having one condition, 1,851 (7.2%) having two, and 1,045 (4.1%) having three conditions. To ensure the mental health and well-being of medical students, the NMC Task Force has issued the several recommendations to the medical colleges across the country.

The survey, which included 25,590 undergraduate students, 5,337 postgraduate students, and 7,035 faculty members recommended that resident doctors work no more than 74 hours per week, get a weekly one-day off and seven-eight hours of daily sleep.

It also recommended that colleges organise and maintain diverse sports activities, overseen by a sports committee, with dedicated time allotted for physical activities.

Further, to mitigate social isolation and enhance the well-being of medical students, it is crucial to implement a policy supporting the establishment of diverse social groups in medical colleges, the National Task Force on Mental Health and Well-being of Medical Students of the National Medical Commission (NMC) said in its report released recently.

The Samajika Sanskriti Campus Council can be set up aimed to reduce social isolation and enhance well-being by supporting diverse social groups and activities in medical colleges. Headed by senior faculty and student representatives, it would allocate resources for various cultural, recreational, and festival events, the task force recommended.

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

Yoga is increasingly recognised as an effective practice for promoting mental health, preventing mental illness, and developing resilience among medical students, the task force highlighted. Regular yoga practice reduces stress and anxiety, enhances mood through the production of endorphins, and improves mindfulness by helping students stay present and focused.

“Yoga also plays a crucial role in preventing mental illnesses by addressing early signs of mental distress and equipping students with healthy coping mechanisms to manage the pressures of medical education,” the task force said.

“Medical colleges can integrate yoga into students’ lives by organising regular classes, workshops, and seminars, providing resources for self-practice, including yoga in the curriculum, and creating a supportive environment that emphasises the importance of self-care,” it stated.

For High-Risk Group Identification and Referral, the task force proposed a comprehensive peer support model in medical colleges, leveraging senior students to support juniors, aiming to improve mental health, provide academic and emotional support, and prevent suicide.

The programme includes safe spaces, anonymous reporting, professional support integration, mental health awareness campaigns, and suicide prevention workshops.

It further stated that students dependent on substances should be encouraged to seek help while maintaining confidentiality rather than be reprimanded. “This policy focuses on health and recovery, acknowledging that substance dependence is a health issue requiring professional intervention. Ensure that de-addiction services are readily accessible to students on campus,” the task force said in its recommendations.

In the ‘Recommendation for Students with Mental Illness or Attempted Suicide’, the task force stated that every medical college must establish a Department of Psychiatry with sufficient psychiatrists, counsellors, nurses, and support personnel.

A crisis intervention strategy shall be in place to inform and involve immediate family members during mental health crises such as attempted suicide and mental health emergencies. An evaluation committee should be formed to assess ‘fitness to practice’. There should be an aim to balance the rights and well-being of medical students with mental health issues against the imperative to maintain patient safety and quality care at the medical college, the task force said.

It also stressed on enforcing mandatory reporting of suicide attempts and deaths by suicide to ensure data collection, accountability, and the development of targeted interventions for mental health support. The task force also provided specific suggestions for medical students in which it stressed on effective time management, saying much stress results from unfinished assignments and poor time management and suggested students develop habits that are in keeping with the requirements of their curriculum.

It urged them to avoid overloading, practice mindfulness/meditation, do regular exercise, sports activity or yoga, inculcate healthy sleeping and eating habits and connect with peers, family, and mentors for emotional support and learn to handle unfamiliar challenging situations.

“Many students have very high expectations of themselves and always wish to perform with perfection. Excessive competition can also result in undue stress. It is suggested that students should set realistic expectations and focus on learning rather than perfection,” the task force said.

“Medical students should seek professional help to tide over difficult periods and also if they find it difficult to cope with the demands of the course,” it stressed.

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Bristol Myers Squibb India Gets CDSCO Panel Nod to Study anticancer drug Mezigdomide

New Delhi: The drug major Bristol-Myers Squib has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the anti-cancer drug Mezigdomide.

This came after the firm presented phase 3 clinical study protocol no. CA057001 version 04 dated 10 May 2023. This is a phase 3, two-stage, randomized, multicenter, open-label study comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) versus Pomalidomide, Bortezomib, and Dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-1.

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Mezigomide is an oral cereblon E3 ligase modulator (CELMoD) that is under clinical investigation in patients with relapsed/refractory (RR) multiple myeloma (MM).

Mezigdomide is a modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities. Upon administration, mezigdomide specifically binds to cereblon (CRBN), thereby affecting the ubiquitin E3 ligase activity, and targeting certain substrate proteins for ubiquitination. This induces proteasome-mediated degradation of certain transcription factors, some of which are transcriptional repressors in T-cells. This leads to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. CRBN, the substrate recognition component of the CRL4-CRBN E3 ubiquitin ligase complex, plays a key role in the ubiquitination of certain proteins.

At the recent SEC meeting for oncology, the expert panel reviewed phase 3 clinical study protocol no. CA057001 version 04 dated 10 May 2023.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read: GSK Pharma India Gets CDSCO Panel Nod for phase 3 CT of Belrestotug and Dostarlimab

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Faculty Post At ESIC Medical College And Hospital Kalaburagi, Karnataka: Check Walk-In-Interview Details

Bengaluru: The Employees State Insurance Corporation Medical College and Hospital (ESIC Medical College and Hospital Kalaburagi) has announced vacancies for the Faculty Post on a Contract Basis. The final selection will be based on performance in the personal interview.

ESIC is a statutory body constituted under an Act of Parliament (ESI Act, 1948) and works under the administrative control of the Ministry of Labour and Employment, Government of India.

Vacancy Details:

Total no. of vacancies- 22

Professor:- 06

The Vacancies are in the Department of Biochemistry, Forensic Medicine, Orthopedics, Radio Diagnosis, Psychiatry, and Physical Medicine & Rehabilitation.

Associate Professor:- 16

The Vacancies are in the Department of Biochemistry, General Medicine, Paediatrics, Psychiatry, Orthopaedics, ENT, Anaesthesiology, Radio Diagnosis, Emergency Medicine, and Physical Medicine & Rehabilitation.

Registration and Document Verification timings 28th August 2024 9:00 AM to 10:30 AM

Personal interview 29th August 2024 9:30 AM onwards

Venue: Office of the Dean, ESIC Medical College, Kalaburagi, Karnataka.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:
https://medicaljob.in/jobs.php?post_type=&job_tags=ESIC+Kalaburagi&location=&job_sector=all

What are the General Conditions for Eligible Candidates?

a) Candidate can walk-in and register for interview from 09:00AM to 10:30 AM on 28.08.2024. No candidate will be entertained after 10:30 AM.

b) Application form is enclosed with the advertisement.

c) All eligible candidates should apply through the application form enclosed with the advertisement and must fill the application form before registration process.

d) Candidates should produce all the original documents in respect of all the parameters filled in the form during scrutiny on the day of Walk-in-Interview.

e) Candidates are requested to report by 9 AM at the venue on scheduled dates.

f) Please bring all following relevant Original certificates and their self-attested photocopies (1 set), 2 copies of passport size photographs and the relevant certificates issued by the competent authority in the form prescribed by Government of India, Department of Personnel & Training for consideration of reservation to the reserved candidates, failing which they will not be allowed for interview. “No photocopies will be arranged/ provided by the office under any circumstances.”

List of Documents to be produced at the time of Interview :

• SSC/10th Standard Certificate as proof of age.

• M.B.B.S Certificate

• PG Degree Certificate

• Registration with Karnataka State Medical Council (KMC)/NMC

• Caste Certificate issued by the Competent Authority, if applicable

• Experience Certificate

• Relieving Certificate from Previous institution

• Proof of ID (Aadhar Card and PAN Card)

• Passport size 02 photograph

• Other documents /Publications as per NMC criteria for faculty appointment.

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Only 1 medical college in Gujarat gets NMC renewal, 37 institutes awaiting nod

Among the 38 existing medical colleges in Gujarat, only one has received the National Medical Commission’s (NMC) annual renewal permission.
TOI has reported that only one private medical college in Kalol has received the required renewal permission from the Commission so far, while the remaining 37 colleges are still awaiting for the Commission’s nod.
For more information, click on the link below:

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UP DGME issues Instructions For Round 3 NEET MDS Counselling Candidates, Details

Uttar Pradesh- Director General, Medical Education and Training (DGME), Uttar Pradesh, through a notice, has given necessary information regarding the resignation of candidates who got admission through online UP National Eligibility and Entrance Test-Master of Dental Surgery (NEET MDS) 2024 counselling.

As per the notice, such candidates who have been allotted seats in the 1st/2nd round of NEET MDS 2024 counselling in the government and private sector, but want to resign from the admitted seat, then such candidates can submit their resignation by appearing personally at the nodal centre related to the admitted seat by 2:00 PM on 22 August 2024.

Meanwhile, UPDGME is going to conduct the NEET MDS 3rd round of online counselling from 21st August 2024 which will continue till 30th August 2024. In this regard, UPDGME has issued necessary guidelines regarding the NEET MDS 3rd round 2024 counselling.

The necessary guidelines are as follows-

1 Those candidates who for some reason could not register in the 1st and 2nd rounds of counselling or could not deposit the registration fee, can participate in the counselling process by registering online for the 3rd round and depositing the registration fee of Rs. 3000/-.

2 The allotment of seats in the 3rd round of counselling will be based on the All-India Rank as per the merit list of the 3rd round.

3 At the time of choice filling in the 3rd round of counselling, the vacant/not reported and resigned seats of the 2nd round will be displayed to the candidates as clear-cut vacancies.

4 In the 3rd round of counselling, the option of Seat Against Cancellation (SAC) will also be shown to the candidates. SAC seats are a type of virtual vacancy, under which, at the time of choice filling, candidates will be shown the option of other reserved category seats in addition to the vacant seats of their own category. If any seat of the reserved category remains vacant at the time of the allotment process, then such seats will be allotted.

5 The candidate must lock the choice after filling the choice, in case of not locking the choice, the candidate will not be included in the process of seat allotment, the entire responsibility of which will be on the candidate.

6 Candidates who are unallocated and admitted in the 1st and 2nd rounds of counselling will not be required to deposit the earnest money again to participate in the 3rd round of counselling.

7 In case the allotted candidates do not take admission in the 2nd round of counselling, they will have to deposit the earnest money again for participating in the 3rd round of counselling.

8 If the candidates admitted in the 1st and 2nd rounds of counselling want to resign from the seat for which they have entered, then such candidates will have to deposit the earnest money again for the 3rd round of counselling.

9 If any other seat is allotted as per the option given by the candidate for reallocation, then the previously allotted seat will automatically become vacant and will be allotted to some other candidate. In case of no reallocation, the seat previously entered by the candidate will remain as it is.

10 It must be ensured by the candidate that for reallocation, other options are filled except for the previously admitted seat, otherwise if the previously admitted seat is re-allocated, then the candidate will have to appear at the nodal centre and re-allocate. The admission process will have to be completed as before.

11. After the allotment from the 3rd round of counselling, the candidates allotted in government sector colleges will have to complete their admission process by appearing at the respective dental college/university and the candidates allotted in private sector colleges.

12. For government and private sector dental colleges, it will be mandatory for the candidate to get admission to the seat allotted by the 3rd round of counselling, otherwise the entire earnest money deposited will be confiscated.

13. If a candidate admitted through the 1st/2nd round of counselling for government sector dental colleges does not take admission in the 3rd round of counselling after reallocation, then the entire earnest money deposited by the candidate and all the fees deposited at that time will be confiscated.

14 The fee will be confiscated for private sector dental colleges, if a candidate admitted through the 1st/2nd round of counselling does not take admission in the 3rd round of counselling after reallocation, then the entire earnest money deposited by the candidate and 50 per cent of the tuition fee deposited at that time will also be confiscated.

15 CTS bank draft of the tuition fee prescribed by the government by the candidates allotted in private sector dental colleges, issued in favour of Director General Medical Education & Training U.P should be payable at Lucknow. It will be mandatory to deposit the same at the concerned nodal centre, otherwise the admission will be considered automatically cancelled. The tuition fees determined by the government and the fee structure of minority institutions are available on the departmental official website.

16 It is mandatory for the allotted candidates to undergo medical examination from the medical board constituted at the Dental College/Nodal Centre.

To view the instructions, click the link below

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Health Bulletin 17/ August/ 2024

Here are the top health stories for the day:


Man attempts to abuse female doctor at Coimbatore Medical College Hospital; doctors protest
Over 150 trainee doctors held a sit-in protest demanding increased protection after a youth allegedly attempted to harass a female doctor in the parking area of Coimbatore Medical College Hospital (CMCH) in Tamil Nadu on Wednesday.
The incident took place at 9:30 pm on Wednesday when the female doctor was about to get into a vehicle in the parking area of the hospital.
For more information, click on the link below:
NMC urges adoption of AIIMS Delhi pay scale, retirement code for all medicos nationwide
The National Task Force of the National Medical Commission (NMC) has recommended implementing a uniform pay scale structure and retirement policy for all the medicos including interns, postgraduate students, super-specialty students, and medical college teachers.
In its report, the NMC Task Force has recommended that the pay scale of All India Institute of Medical Sciences (AIIMS), New Delhi should be adopted for all medical students and teachers to ensure equity and fairness to promote job satisfaction.

For more information, click on the link below:

Autopsy in Kolkata medic’s rape-murder reveals multiple penetrations, severe injuries
The autopsy report of the woman postgraduate student who was allegedly raped and murdered at RG Kar Medical College and Hospital has revealed multiple penetrations and injuries to various parts of her body.
The report confirmed that her death was “homicidal” and occurred before her death, refuting claims that she was raped post-mortem.

For more information, click on the link below:

File FIR in 6 hours: Centre’s order to protect healthcare workers after Kolkata doctor’s rape, murder
Amid the massive outrage and nationwide protests over the brutal rape and murder of a Postgraduate doctor in Kolkata R G Kar Medical College and Hospital, the Union Health Ministry has now issued strict directions to the medical institutes and hospitals across the country to file an institutional FIR within six hours of an incident of violence against any healthcare worker on duty.
The Director General of Health Services (DGHS) Dr. Atul Goel shared this Office Memorandum with the directors and medical superintendents of central government hospitals, including AIIMS, and the directors/principals of all medical colleges across the country.
For more information, click on the link below:

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PG Medico Rape-Murder Case: Former RG Kar Principal questioned by CBI for second day

Kolkata: The controversial former principal of R G Kar Medical College and Hospital in Kolkata, Sandip Ghosh has once again appeared before the Central Bureau of Investigation (CBI) for questioning on Saturday for the second consecutive day in connection with the brutal rape and murder of a postgraduate student at the hospital.  

Earlier, the agency escorted the former hospital principal for questioning on Friday after he allegedly avoided repeated summons by CBI officials to appear for questioning following the Calcutta High Court order that asked Ghosh to appear before the agency.   

As per a TOI news report, the agency yesterday detained Ghosh near the City Centre in Salt Lake, asked him to leave his vehicle, and then took him to the CBI office in their car.  

Upon his arrival, Ghosh was made to sit in a room at the CBI’s city office here at the CGO Complex till 9.30 pm after which the grilling session started which lasted till 3 am on Saturday.

Also read- Doctors at CNMC refuse to accept Dr Sandeep Ghosh as principal unanimously shouting slogans of Go back

It was revealed that the agency brought him in for interrogation on Friday after the Calcutta High Court declined to consider Ghosh’s request for security, which he sought due to feeling threatened upon being summoned by the agency.

Today, Ghosh reached the CBI office for the second time a little before 10.30 am for his second round of examination.

During his first round of questioning, the former principal was asked about his first reaction after getting the news of the doctor’s death whom he instructed to inform the family and how and who contacted the police, the officer said. 

As per The Statesman, Ghosh was also asked questions about whether he had ordered the demolition of the washroom near the seminar hall in the chest medicine department under the name of renovation work to tamper with evidence related to the incident.

“Certain answers were convoluted. He was grilled till early Saturday and then allowed to leave for home,” the officer told PTI. Ghosh was also asked about the weekly roster where the victim was seen to be put on duty for gruelling 36 hours or at times even 48 hours, he said.

The former principal had resigned from the post two days after the body was discovered. He had expressed fears of being attacked, prompting his lawyer to seek protection from the Calcutta High Court. However, the court directed him to approach a single bench.

CBI summons 4 doctors

On Friday, four doctors of RG Kar Medical College and Hospital were summoned by the Central Bureau of Investigation (CBI), Kolkata in connection with the case. According to the sources, the CBI interrogated these PGT (PG trainees) regarding what happened the night of the incident.

On Thursday, the CBI questioned three batchmates of the trainee doctor who were on duty on the night of August 8. The former head of the chest medicine department of the hospital was also questioned by the central probe agency.

Parents claim colleagues involved in crime

The parents of the woman doctor, who was allegedly raped and murdered inside the RG Kar Medical College and Hospital last week, have told the CBI that a few interns and physicians of the same medical establishment were involved in the crime.

The parents also provided the central agency, which is conducting the probe into the case on an order of the Calcutta High Court, with names of those who they suspect to be associated with their daughter’s killing in the state-run hospital.

“The parents told us that they suspect the involvement of multiple persons behind the sexual assault and murder of their daughter. They have given us names of a few interns and doctors working with their daughter at the RG Kar Hospital,” the CBI officer told PTI.

The central agency officer said that they were giving priority to questioning the doctors and officers of the Kolkata Police who were part of the investigation.

“We have zeroed in on at least 30 names whom we will be calling for questioning. We have already started questioning them,” he said.

The body of the post-graduate trainee was found in the RG Kar Hospital’s seminar room on August 9. The police arrested a civic volunteer the next day in this connection. The CBI on Friday took the arrested man to the Hospital for a reconstruction of the crime scene, the source said. 

Also Read: Medical Bandh: OPDs, elective surgeries shut as Nationwide doctors go on strike over Kolkata doctor murder case

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USFDA grants accelerated approval to Gilead Sciences Livdelzi for Primary Biliary Cholangitis

Foster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.

The accelerated approval was based primarily on data from the pivotal placebo-controlled Phase 3 RESPONSE study. In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo. Treatment with Livdelzi led to normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12. This change was not seen in any trial participants receiving placebo. Change from baseline pruritus score at month 6 was a key secondary endpoint; patients treated with Livdelzi demonstrated a statistically significant reduction in pruritus compared with placebo.

The FDA approved Livdelzi under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).

“More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, President, The PBCers Organization. “The availability of a new treatment option that can help reduce this intense itching while also improving biomarkers of active liver disease is a milestone for our community.”

PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and can cause liver damage and possible liver failure if untreated. The disease currently has no cure.

Livdelzi, an oral, peroxisome proliferator activated receptor (PPAR) delta agonist, or delpar, is positioned to challenge the current PBC standard of care, which falls short for many people who experience inadequate response to treatment, putting them at risk for continued liver damage. Livdelzi has demonstrated a sustained efficacy and safety profile across its robust development program to date, including a capacity to normalize ALP levels for some of the people studied with PBC. Given ALP levels are recognized as an important surrogate marker of disease progression in PBC, providers are shifting to view ALP normalization as a treatment goal.

“People living with PBC have been waiting for treatment advancements for many years. The approval of Livdelzi, with its distinct profile, provides them with an important new option,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to leveraging Gilead’s long-standing expertise in liver disease to bring this promising new treatment to all those who could benefit.”

The RESPONSE study, in addition to other studies including the long-term open-label ASSURE study and prior earlier phase studies, together represent the experience with Livdelzi in more than 500 participants with PBC. Ongoing studies include the confirmatory Phase 3 AFFIRM study, a randomized, placebo-controlled confirmatory study designed to evaluate the effect of Livdelzi on clinical outcomes in people with compensated cirrhosis due to PBC.

In the RESPONSE study, Livdelzi, given alone or in combination with UDCA as an oral, once-daily medicine, reduced key biomarkers of PBC disease and helped reduce pruritus (chronic itch), which is a common symptom that can significantly impair quality of life in people with PBC.

As per the release, Livdelzi is the only medicine to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression in a Phase 3 trial. The primary endpoint of the study was a composite biochemical response at month 12, where biochemical response was defined as achieving ALP less than 1.67-times upper limit of normal (ULN), an ALP decrease of greater than or equal to 15% from baseline, and total bilirubin less than or equal to ULN. ALP normalization (i.e., ALP less than or equal to ULN) at month 12 and change from baseline in pruritus score at month 6 were key secondary endpoints.

Read also: CMO Merdad Parsey to leave Gilead Sciences

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Medical Bulletin 17 August/ 2024

Here are the top medical news for the day:

New Machine Learning Method Identify Subtle Movement Deficits in Early Parkinson’s Disease
A new research published in the journal Parkinsonism and Related Disorders, suggests that use of machine learning (ML) can detect movement deficits in early-stage Parkinson’s disease from the videos. This technique measures motor symptoms in the early stages of Parkinson’s disease and could uncover signs of the condition and other movement disorders sooner, potentially leading to improved treatment outcomes.
A research team from the University of Florida and the Fixel Institute for Neurological Diseases has demonstrated that using video analysis can aid in identifying early signs of Parkinsonism in individuals. Their method involves comparing the movement of the left and right sides of a person’s body. According to the researchers, this technique leverages the characteristic asymmetry of Parkinson’s disease, which typically begins with more pronounced symptoms on one side of the body compared to the other in the initial stages. This asymmetrical onset allows the video-based approach to detect subtle differences in movement that may indicate the early presence of the disease.
The researchers employed machine learning techniques to analyze videos of individuals executing basic hand and leg movements, which are routinely assessed by neurologists. By examining these videos, the team sought to identify subtle variations between healthy individuals and those in the early stages of Parkinson’s disease. Their innovative approach successfully distinguished between the two groups with an accuracy rate of 86%. This level of precision highlights the effectiveness of their method in detecting early Parkinson’s disease by analysing nuanced differences in movement patterns.
This technology is user-friendly, easily scalable, and offers significant potential to enhance the monitoring and measurement of motor symptoms in the early stages of Parkinson’s disease.
Reference: Guarín, D. L., Wong, J. K., McFarland, N. R., Ramirez-Zamora, A., & Vaillancourt, D. E. (2024). What the trained eye cannot see: Quantitative kinematics and machine learning detect movement deficits in early-stage Parkinson’s disease from videos. Parkinsonism & Related Disorders, 107, 107104. https://doi.org/10.1016/j.parkreldis.2024.107104
Urea Cycle Defects Linked to Fatty Liver Disease?
In a recent study published in Cell Metabolism, revealed that a crucial connection between urea cycle defects—which are essential for ammonia detoxification in the body—and the onset of fatty liver disease.
Researchers discovered that defects in the urea cycle cause secondary disruptions in the tricarboxylic acid (TCA) cycle, an essential pathway for energy metabolism. This disruption leads to poor calorie use and excessive fat accumulation in the liver, which can result in inflammation and fibrosis, thereby advancing the progression of the disease.
Fatty liver is considered a major contributor to liver failure and by highlighting the essential role of the urea cycle in the disease’s development this research could lead to the creation of new treatments for this currently untreatable condition.
The two main types of fatty liver disease are metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). Both involve excessive fat accumulation in the liver, which can lead to liver failure if not addressed. These conditions are increasingly common among children and often present more severely in this population.
Researchers analyzed blood metabolites from 106,600 healthy participants in the. Her analysis found that certain metabolites linked to nitrogen and energy metabolism, as well as mitochondrial function, could predict the risk of severe liver diseases even in healthy individuals. Cao noted that these findings, supported by both human and mouse research, highlight the crucial role of the urea cycle in understanding severe liver diseases.
Reference: Zhang, Y., et al. (2024). Hierarchical tricarboxylic acid cycle regulation by hepatocyte arginase 2 links the urea cycle to oxidative metabolism. Cell Metabolism. doi.org/10.1016/j.cmet.2024.07.007.
Is Magnesium Important for Optimal Health?
In a recent study published in the European Journal of Nutrition, researchers investigated whether magnesium deficiency, either on its own or combined with elevated homocysteine levels, was linked to DNA damage in a healthy middle-aged population.
Study reveals that people with both high homocysteine levels and magnesium deficiency showed elevated levels of nucleoplasmic bridges and micronuclei in their blood compared to those with high magnesium levels and low homocysteine. These findings suggest that magnesium is crucial for shielding nucleic acids from internal genotoxic damage.
Magnesium is one of the four most prevalent minerals in the human body and is essential for DNA repair and replication. It acts as a cofactor for several enzymes that are crucial for nucleic acid repair and replication. Additionally, magnesium is important for bone development, nerve function, protein metabolism, cell growth, and the regulation of blood pressure and blood sugar levels.
For the study researchers recruited participants aged 35 to 65 who were healthy, non-smokers, and had no diagnosis of Alzheimer’s disease or mild cognitive impairment were recruited. Individuals taking medications for serious illnesses like cancer or using daily supplements of minerals, vitamins, or fish oil.
Blood samples were collected from all participants after an overnight fast over a six-month period to measure various biomarkers of DNA damage. The cytokinesis-block micronucleus assay was employed to evaluate the presence of micronuclei, nuclear buds, and nucleoplasmic bridges in the blood.
Additionally, the findings indicated that adequate intake of vitamin B12 and magnesium can support genomic integrity and reduce homocysteine levels, which may promote healthy aging.
Reference: Dhillon, V. S., Deo, P., & Fenech, M. (2024). Low magnesium in conjunction with high homocysteine increases DNA damage in healthy middle-aged Australians. European Journal of Nutrition. DOI:10.1007/s00394024034490
https://link.springer.com/article/10.1007/s00394-024-03449-0
Clostridium Difficile develops resistance to antibiotics.
In a recent study published in the PLoS Biology researchers have identified how the hospital superbug Clostridioides difficile (C. diff) can swiftly develop resistance to vancomycin, the primary.
Scientists discovered that within just two months, the bacteria could develop resistance to 32 times the original concentration of the antibiotic.
Clostridioides difficile (C. diff), a bacterium that commonly affects individuals who have been on antibiotics, is recognized by the World Health Organization as a major global public health threat and is responsible for around 2,000 deaths each year.
Currently, antibiotics used to treat C. diff also harm beneficial gut bacteria, resulting in a high rate of reinfection—up to 30 per cent of patients treated with vancomycin experience a second infection within weeks, and the risk of subsequent relapses increases over time.
Scientists have discovered two distinct mechanisms of resistance, both leading to modifications in the terminal D-Ala-D-Ala of muropeptides, the primary vancomycin target. One mechanism involves a novel D, D-carboxypeptidase, whose expression is regulated by a specific two-component signal transduction system. Our research indicates that although C. difficile has the potential to develop high-level vancomycin resistance, this resistance might be clinically limited due to associated effects on essential pathogenic traits. Additionally, these findings highlight potential mutational pathways to resistance that should be monitored in genomic surveillance.
Despite the vital role of vancomycin in healthcare, routine monitoring for resistance is not common in clinical settings, allowing resistance to potentially develop unnoticed in hospitals. If widespread resistance were to occur, it could eliminate this crucial treatment option.
The World Health Organization (WHO) has recognized antimicrobial resistance (AMR) as a leading global public health and development threat. In 2019, it is estimated that bacterial AMR was directly responsible for 1.27 million deaths worldwide and contributed to a total of 4.95 million deaths.
Reference: Buddle JE, Thompson LM, Williams AS, Wright RCT, Durham WM, Turner CE, Chaudhuri RR, Brockhurst MA, Fagan RP. Identification of pathways to high-level vancomycin resistance in Clostridioides difficile that incur high fitness costs in key pathogenicity traits. PLoS Biol. 2024 Aug 15;22(8):e3002741. doi: 10.1371/journal.pbio.3002741. PMID: 39146240
The Role of Probiotics in Prenatal Health: Benefits for Moms and Babies
A recent study conducted by The Ohio State University Wexner Medical Center and College of Medicine found that administering probiotics to pregnant mice can improve both the immune system and behaviour of the mothers and their offspring.
The study results have been published online in the journal Brain, Behavior, and Immunity. Probiotics, which are live microorganisms like bacteria, support healthy digestive and immune systems. Numerous studies have confirmed their benefits, and they are generally regarded as safe to use during pregnancy.
The authors discovered that the probiotic Bifidobacterium dentium might alter the body’s processing of specific amino acids, including tryptophan. During pregnancy, tryptophan plays a role in regulating inflammation and supporting brain development.
Researchers has investigated how prenatal stress can result in atypical brain development and behavioural alterations in offspring. Their findings indicate that stress is associated with changes in brain inflammation, amino acid metabolism, and long-term reductions in social behaviour, along with abnormal microbiomes in the offspring.
This study advances their knowledge of how gut microbes and probiotics can affect amino acid metabolism and address behavioural and immune issues related to prenatal stress. It also underscores the significant benefits of this particular probiotic, even in the absence of stress.
Further, it is concluded that Bifidobacterium dentium can influence the immune system, metabolism, and behaviour of both the mother and her baby during and after pregnancy. It might help prevent the negative effects of stress.
Reference: Galley JD, King MK, Rajasekera TA, Batabyal A, Woodke ST, Gur TL. Gestational administration of Bifidobacterium dentium results in intergenerational modulation of inflammatory, metabolic, and social behavior. Brain Behav Immun. 2024 Aug 12;122:44-57. doi: 10.1016/j.bbi.2024.08.006. Epub ahead of print. PMID: 39128569.

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