Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi

New Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the post-marketing safety data of Belumosudil from all the countries where the drug is approved for marketing.

This came after the drug maker Sanofi presented the proposal for the grant of permission to import and market of drug Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019 as the Chronic graft versus host disease (GvHD) is a rare condition affecting less than 1000 patients in India.
Belumosudil tablets 200 mg are approved in the US, Canada, Great Britain, Australia, China, and Israel. Belumosudil is designated as a breakthrough therapy by the US FDA and also granted priority review in the US and Canada.

Belumosudil is an oral inhibitor of rho-associated coiled-coil-containing protein kinases (ROCK) used in the treatment of chronic graft-versus-host disease (GVHD).

Graft-versus-host disease (GvHD) is a systemic disorder that occurs when the graft’s immune cells recognize the host as foreign and attack the recipient’s body cells. “Graft” refers to transplanted, or donated tissue, and “host” refers to the tissues of the recipient. It is a common complication after allogeneic hematopoietic stem cell transplant (HCT)

Belumosudil is indicated for the treatment of chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older following failure of at least two other lines of systemic therapy. Chronic graft-versus-host disease (GVHD) is a life-threatening complication of allogeneic hematopoietic stem cell transplantation in which the transplanted donor T-cells recognize the recipient’s tissues as foreign and mount an immune response.

At the recent SEC meeting for Haematology held on 19th March 2024, the expert panel reviewed the proposal presented by the drug major Sanofi for the grant of permission to import and market Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019.
After detailed deliberation, the committee opined that Chronic graft-versus-host disease (GvHD) is a rare condition and there is an unmet need in the country.
However, the committee opined that: –
1. The firm should submit the post-marketing safety data from all the countries where Belumosudil is approved for marketing.
2. The firm should submit proper interventional Phase IV clinical trial protocol with adequate methodology and sample size.
Accordingly, the expert panel suggested that the firm should submit the post-marketing safety data of the drug Belumosudil from all the countries where the drug Belumosudil is approved for marketing and Phase IV clinical trial protocol before the committee for further consideration.

Also Read:Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

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Study shows experts rate influenza as the number one pathogen of concern of pandemic potential

New research presented at the ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27–30 April) shows that in a VACCELERATE Consortium survey study in which infectious diseases experts were asked to rank pathogens in order of their pandemic potential, influenza was considered the pathogen of highest pandemic risk, with 57% ranking influenza as number one, and a further 17% ranking it second.

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H. pylori testing feasible for people in community settings

Community Helicobacter pylori (HP) testing in high-risk individuals is technically feasible, according to a study published online April 3 in Clinical Gastroenterology and Hepatology.

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Sugar cravings could be caused by loneliness, study finds

If you’ve spent a lonely night at home eating chocolates and/or ice cream, you shouldn’t feel guilty. That’s because loneliness can cause an intense desire for sugary foods, a new study found.

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Postpartum low-dose esketamine aids moms with prenatal depression

A single low dose of esketamine after childbirth reduces depressive episodes at 42 days postpartum among mothers with prenatal depression, according to a study published online April 10 in The BMJ.

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Occupations that are cognitively stimulating may be protective against later-life dementia

People with a history of cognitively stimulating occupations during their 30s, 40s, 50s, and 60s had a lower risk of mild cognitive impairment (MCI) and dementia after age 70, according to a new study from Columbia University Mailman School of Public Health, the Columbia Aging Center, and the Norwegian Institute of Public Health. The findings highlight the importance of cognitive stimulation during midlife for maintaining cognitive function in old age.

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AIIMS Kalyani To Conduct Interviews for Externship Program for July-December 2024 Session, details

West Bengal- All India Institute of Medical Sciences (AIIMS), Kalyani is going to conduct interviews for the Externship Program in various departments of AIIMS, Kalyani, West Bengal for the July-December session, 2024. On this, AIIMS, Kalyani has issued a notice detailing the application process, fee, mode of selection, etc.

The Observership or short term training of external students are termed as externship

HOW TO APPLY

Interested candidates will have to fill out the Google form and also attach the necessary documents with it, the link to the Google form is given in the notice. Candidates are advised to fill up each & every column of the application form & read the instructions/ guidelines carefully before filling up the form. Incomplete applications will be rejected straightaway. The application form is available till 30th April 2024 till 05:00 PM. No hard copy of the application would be accepted.

Also Read: AIIMS Kalyani Releases List Of Provisionally Ineligible Candidates For Externship Program

FEE

Only selected student has to deposit the stipulated course fee of Rs.1000/month to the Academic Section through Demand Draft only as per the prescribed norms before starting the externship. The same will be deposited by the academic section to the Accounts section following the direction of the competent authority.

MODE OF SELECTION

Following the shortlisting/verification of applications received the eligible candidates will be called for an interview. The selection of the candidates will be based on their performance in the interview only.

The interview for the Externship Program will be held at the Administrative Building, Ground Floor, Welcome Centre, AIIMS, Kalyani, West Bengal. However, the date and time will be notified on the AIIMS Kalyani official website soon.

Also Read: AIIMS Kalyani Announces Externship Program For UG, PG medicos, details

IMPORTANT POINTS

1 Any student pursuing graduate/ PG courses of any particular institute of state government or central government or NAAC accredited reputed private institute will be eligible to apply for this externship program for a minimum of one month and a maximum of six months.

2 Candidates have to submit their applications along with the Authorisation letter while addressing the Executive Director of AIIMS, Kalyani from the institute authority where the student is actively pursuing the course. Students who have passed out or appearing for the examination are not allowed.

3 In any case neither the present institute of the student nor the candidate can write directly to any department concerned where the candidate is interested in undergoing an externship.

4 Eligibility of a candidate for externship does not automatically entitle them for selection.

5 Applicants who have previously received training/externship at AIIMS, Kalyani may not be considered for again.

6 On successful completion of the training period, candidates will be issued a certificate of attendance and course completion by the academic section after due approval from the competent authority. Certificate of Attendance will be issued for fulfilling the requirements of the course pursued by the student. Any department of AIIMS Kalyani will not issue any certificate to this effect

7 The Institute does not provide any hostel accommodation for the externship program.

To view the notice, click the link below

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Two women undergo robot-assisted Breast Preservation Surgery at CK Birla Hospital

New Delhi: In a landmark medical advancement, CK Birla Hospital®, Delhi has successfully treated two women suffering from complex and advanced breast cancer with the help of robotic-assisted breast preservation surgery. This is one of the first in India case where this unique technique has been used to preserve full breasts and nipple sensation. The team of doctors led by Dr. Mandeep Singh Malhotra, Director of Surgical Oncology at CK Birla Hospital®, Delhi performed robot-assisted functional breast preservation surgery (RAFBPS), which is a minimally invasive surgical technique performed using Da-Vinci Robot. 

A 27-year-old woman was presented at the hospital with a breast lump, a few months after her baby was born. Due to her denial and masking of symptoms associated with changes in the breast during pregnancy and lactation, the cancer progressed to an advanced stage. The woman was administered with Neo Adjuvant Chemotherapy, which allows for optimal removal of residual tumor, along with targeted medicine and she responded exceptionally well to this systemic treatment. The patient underwent RAFBPS without complications and experienced a swift recovery. Despite her initial fear of losing her breasts, RAFBPS not only preserved her breasts, but also provided her with functional, sensate, and similar breasts like her original ones. 

Also Read:Rare case of Half Uterus: Doctors at CK Birla Hospital successfully treats 27-year-old woman

In another case, a woman in her late 50s was diagnosed with early-stage of breast cancer but the cancer was multifocal i.e. she had 3 breast lumps. The patient was in a lot of distress due to the expected loss of breasts and the morbidity it would cause. Identified as a candidate for immediate surgical intervention, she underwent RAFBPS. This surgical procedure utilized robotic arms to remove the cancerous tissue and simultaneously harvesting tissue from the back to reconstruct the breast; with a single lateral mammary incision. Following the successful surgery, the woman recovered well and now enjoys a healthy and fulfilling life.

Dr Mandeep Singh Malhotra, Director of Surgical Oncology at CK Birla Hospital®, Delhi, said, “One of the first in India, where Robot-assisted functional breast preservation surgery with Latissimus flap reconstruction has been conducted at our hospital. This surgery offers more precise visualization and smaller incisions. In these types of surgeries, robot is used to enter the breast from the armpit to remove tissue and reconstruct the breast, preserving the breast skin as well as nipple, if possible, thus preserving the breast sensation. This procedure provides remarkably natural looking outcomes while preserving full breast sensation. By retaining the original breast skin and nipple, the breast sensation remains intact, hence the breast looks as well as feels like the original breast and the robot makes this surgery simpler with better aesthetics. Loss of breast is morbid for women of any age and should be equally evaluated for the option of breast preservation. This procedure is recommended for women having early-stage breast cancer without involvement of overlying skin/nipple and those women who have responded very well to Neo Adjuvant Chemotherapy/ Systemic Therapy.”

Breast cancer is now the most common cancer affecting women in India. It constitutes 14% of female cancers, posing a significant challenge. For every two women diagnosed, one sadly succumbs to the disease. In 2020, 178,361 new cases were reported, with urban women facing a higher risk (1 in 22) than rural women (1 in 60). While cancer-specific mortality (death rate) of ovarian cancer is more than breast cancer, the overall mortality of breast cancer is higher.

Also Read:4.5 kg tumour removed from patient’s breast at CK Birla Hospital

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Takeda gets USFDA nod for Entyvio subcutaneous administration for Crohn’s disease

Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO. The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).

The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2. The primary endpoint was clinical remission*** at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150.

“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”

In VISIBLE 2, a total of 409 patients were randomized at Week 6 in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by SC injection or placebo every 2 weeks. Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders).

A statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission*** compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52. In clinical studies, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for ENTYVIO SC. 

“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”

Takeda does not expect a material impact on the consolidated financial statements as a result of this approval.

Read also: Takeda bags accelerated USFDA nod for Iclusig with chemotherapy in adult patients with newly diagnosed Ph+ ALL

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CENTAC issues notice on Common Entrance Test for BSc Nursing Admissions from this year, details

Puducherry- The CENTAC has recently issued a notice on its website regarding the conduct of a common entrance test for admission to the BSc Nursing course in the UT of Puducherry.

In its notice, the CENTAC notified about the government order referring to the Indian Nursing Council notification. 

“The Indian Nursing Council has intimated that the admission to B Sc. (Nursing) from the academic year 2024-25 shall be made through the Common Entrance Examination by the State Government Common Entrance Cell / Universities in compliance with the Indian Nursing Council (Revised Regulations and Curriculum for B.Sc. (Nursing) Programme), Regulations, 2020”, the official notice stated.

As per the notice, approval to conduct common entrance examination for the BSc (Nursing) course by the Board of Examination for Nurses (BoEN), Directorate of Health & Family Welfare Services of Puducherry for the admission to the Pondicherry University affiliated colleges from the academic year 2024-25 in the state has been granted by the Honorable Lieutenant Governor, Puducherry.

It further stated that the Entire Entrance Examination process should be done by the Board of Examination of Nurses, Puducherry under the directions of the Indian Nursing Council from time to time.

Also Read: JnK Board invites online applications for Bsc Nursing, Paramedical, Technology courses, details

Further, the Deemed Universities in the Union Territory of Puducherry have also been directed to conduct the said entrance examination at their level as per the instructions of the Indian Nursing Council, New Delhi.

Meanwhile, other terms and conditions for admission, scheme of examination etc. will be notified separately and the schedule of the Common Entrance Examination will be notified with the concurrence of the EC1 on account of the Model Code of Conduct being in force.

Indian Nursing Council is a statutory body under the Ministry of Health & Family Welfare, Government of India, New Delhi. It was constituted by the Central Government under Section 3(1) of the Indian Nursing Council Act, 1947 of Parliament to establish a uniform standard of training for nurses, midwives and health visitors.

To view the notice, click the link below

https://medicaldialogues.in/pdf_upload/bscnursing-course-entrance-test-236377.pdf

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