Hypochloremia may increase in-hospital mortality and hospital stay in critically ill patients with HF

Hypochloremia may increase in-hospital mortality and hospital stay in critically ill patients with HF suggests a new study published in the International Journal of Cardiology.

A study was done to assess whether serum chloride predicts risk of death in intensive care unit (ICU) patients with heart failure (HF) and the effect of bicarbonate on the efficacy of serum chloride in predicting risk of death in ICU patients.

Methods: A total of 9364 HF patients hospitalized in the ICU were enrolled. Patients were divided into hypochloremia (< 96 mEq/L), normal chloride (96–108 mEq/L), and hyperchloremia (> 108 mEq/L) groups. Similarly, we divided the serum bicarbonate level into three groups: low bicarbonate (< 22 mEq/L), medium bicarbonate (22–26 mEq/L), and high bicarbonate (> 26 mEq/L). The outcome of this study was in-hospital mortality. Then, we analyzed the association between abnormal serum chloride and mortality according to the category of serum bicarbonate and assessed the interaction effect. Restricted cubic spline (RCS) was used to show possible nonlinear associations.

Results: In the overall study population, hypochloremia was associated with a higher risk of in-hospital mortality than normal chloride (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.26–1.86, P < 0.001), hyperchloremia was not significantly related to in-hospital mortality (OR 1.00, 95% CI 0.85–1.19, P = 0.962). However, a linear association between serum chloride and in-hospital mortality was found in the low and normal bicarbonate groups (all P for nonlinear >0.05).

Hypochloremia is associated with in-hospital mortality and longer hospital stay in critically ill patients with HF. In addition, risk of death in the low and medium serum bicarbonate groups decreased with increasing serum chloride level.

Reference:

The association between serum chloride and mortality in ICU patients with heart failure: The impact of bicarbonate. Zhaochong Tan, M.D. Yang Liu, Kui Hong. Open AccessPublished:December 21, 2023DOI:https://doi.org/10.1016/j.ijcard.2023.131672

Keywords:

Hypochloremia, may, increase, in-hospital, mortality, hospital, stay , critically, ill, patients, HF, International Journal of Cardiology

Powered by WPeMatico

Intranasal Epinephrine Spray Outperforms Autoinjectors for treatment of anaphylaxis

The recent updates to the acute anaphylaxis guideline have highlighted the need for improved therapeutic options to address existing gaps in care as a top priority.

According to a study published in The Journal of Allergy and Clinical Immunology: Global, researchers have concluded that NDS1C offers a needle-free, user-friendly solution for self-administering epinephrine. This is better than the 0.3 mg autoinjector to address unmet medical and patient needs.

This study compares the pharmacokinetic, pharmacodynamic, safety, and tolerability profiles of intranasal and intramuscular epinephrine. One hundred sixteen healthy adults received 13.2 mg intranasal epinephrine, 0.3 mg autoinjector, or 0.5 mg manual syringe intramuscular epinephrine. Participants with 50, 100, and 200 pg/mL epinephrine concentrations were evaluated at 10-, 20-, 30-, and 60 minutes post-dose.

The results of this study could be summarised as follows:

· PK parameters for the 13.2 mg IN dose exceeded those of the 0.3 mg autoinjector with a rapid and higher Cmax and greater systemic exposure.

· The maximum concentration of epinephrine for intranasal spray was 429.4 pg/mL, and for autoinjector was 328.6 pg/mL

· PK parameters for opposite and same nostril dosing were higher than both intramuscular doses except Tmax, which was between the two intramuscular doses (20 min for intranasal, 14.9 min for autoinjector, and 45 min for manual syringe).

· Of the 54 participants, 27 achieved the same epinephrine levels as the autoinjector after opposite-nostril administration in approximately 8.2 minutes, while 33 of the 49 participants with same-nostril administration reached the same levels in 6.2 minutes.

· No severe or unexpected adverse events were reported, confirming the safety and tolerability of intranasal epinephrine.

NDS1C, a nasal spray developed by Bryn Pharmaceutics, delivers epinephrine without requiring a needle. Its compact size makes it easily portable and can be used without specialized medical training. This product aims to provide the allergy community a treatment option similar to the EpiPen autoinjector, currently the preferred treatment for outpatients.

Reference:

Dworaczyk, et al. 13.2 mg Intranasal Epinephrine Spray Demonstrates Comparable Pharmacokinetics, Pharmacodynamics, and Safety to 0.3 mg Epinephrine Autoinjector. Journal of Allergy and Clinical Immunology: Global, 100200.

Powered by WPeMatico

Revise BE study Protocol: CDSCO Panel Tells Akum Pharma on Chlorthalidone, Cilnidipine, Bisoprolol FDC

New Delhi: Citing that individual and innovators products should be taken as a reference product in the proposed bioequivalence (BE) study protocol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akums Drugs and Pharmaceuticals to revise the BE study protocol of the fixed-dose combination drug Chlorthalidone plus Cilnidipine plus Bisoprolol Fumarate film-coated tablet.

This came after the drug major Akums Drugs and Pharmaceuticals presented the proposal along with the BE study protocol before the committee.

Chlorthalidone is a diuretic used to treat hypertension or edema caused by heart failure, renal failure, hepatic cirrhosis, estrogen therapy, and other conditions. Chlorthalidone is a thiazide-like diuretic used for the treatment of hypertension and the management of edema caused by conditions such as heart failure or renal impairment. Chlorthalidone improves blood pressure and swelling by preventing water absorption from the kidneys through inhibition of the Na+/Cl− symporter in the distal convoluted tubule cells in the kidney.

Chlorthalidone prevents the reabsorption of sodium and chloride through inhibition of the Na+/Cl- symporter in the cortical diluting segment of the ascending limb of the loop of Henle. Reduction of sodium reabsorption subsequently reduces extracellular fluid and plasma volume via an osmotic, sodium-driven diuresis. By increasing the delivery of sodium to the distal renal tubule, Chlorthalidone indirectly increases potassium excretion via the sodium-potassium exchange mechanism.

Cilnidipine is a dihydropyridine calcium channel blocker with action on both N- and L-type calcium channels used to treat hypertension.

Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure. Cilnidipine also works on the N-type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

Bisoprolol is a beta-1 adrenergic blocking agent used to prevent myocardial infarction and heart failure and to treat mild to moderate hypertension.

Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long half-life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs.

At the recent SEC meeting for cardiovascular and renal held on 6th and 7th December 2023, the expert panel reviewed the proposal along with the BE study protocol of the Chlorthalidone plus Cilnidipine plus Bisoprolol Fumarate coated tablet presented by Akums Drugs and Pharmaceuticals.
After detailed deliberation, the committee recommended that the BE protocol should be revised.
Furthermore, the expert panel stated, “Individual and innovators products should be taken as the reference product in the proposed BE study protocol.”
Accordingly, the committee suggested that the revised BE study protocol should be submitted to CDSCO for review by the committee.

Powered by WPeMatico

ICMR Announces 5th National NICPR-ECHO Online Certificate Course On Cervical Cancer Screening For Pathologists, details

Delhi: The Indian Council for Medical Research (ICMR) has announced the conduction of the 5th National NICPR-ECHO online certificate course on Cervical Cancer Screening for Pathologists.

The course will be from 17th January 2024 – 1st March 2024, twice a week, 2.30 – 4.30 PM. The candidates need to register for the course. The registration process will be carried out till 31st December 2023. The registration fee of Rs 1000 needs to be paid. The candidates must confirm their seats by paying the registration fee and applying online by completing the Google form. The link to the Google form is enclosed in the notice below.

WHO’s global call for action to eliminate cervical cancer includes screening as one of its pillars. Cytology-based cervical cancer screening has contributed to a reduction in morbidity and mortality. However, the paucity of trained cytopathologists is a deterrent to the effective implementation of cervical cancer screening programs in developing nations.

The Division of Cytopathology, ICMR-NICPR, is conducting the 5th National NICPRECHO Online Certificate Course on Cervical Cancer Screening for Pathologists under the aegis of the Indian Academy of Cytologists. The course shall be conducted solely on the online ECHO platform between 2:30 PM to 4.30 PM on Wednesdays and Fridays. It includes talks by eminent experts on topics pertaining to various aspects of cervical cancer, including epidemiology, screening strategies, and recommendations for cervical cancer screening, with a major focus on cytology-based screening. The didactic deliberations shall be amply supplemented by interactive virtual slide sessions.

Also Read:ICMR Invites Applications For ICMR-IITKGP MedTech Biodesign CLiMB Fellowship Program

Eligibility – This training program is designed only for healthcare professionals who are pursuing or have completed an MD/ DNB in Pathology of possess a Diploma in Clinical Pathology (DCP).

A minimum of one short case presentation and attendance in 10 of 13 sessions is mandatory to qualify for the grant of an e-certificate at the completion of the course. The participants would be required to complete the pre-training and post-training online questionnaire-based evaluation with at least a 70% score in the post-training evaluation.

In case of cancellation of registration or registration by a non-eligible candidate, no refund shall be made. The link to virtual microscopic slides shall be shared with the participants before the course. The participants must ensure a stable internet connection, preferably on a large-screen device.

Case presentations by the participants shall be held at the end of each session. The schedule for the presentations shall be shared with the participants before the start of the course.

Scientific program –

17th January 2023 –

Introduction to the virtual course: learning objectives Epidemiology of cervical cancer, magnitude of the problem, screening strategies & recommendations Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi Dr. Ruchika Gupta, ICMR-NICPR

Epidemiology of cervical cancer, the magnitude of the problem, screening strategies & recommendations Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi Dr. Ruchika Gupta, ICMR-NICPR 17 JAN 19 JAN 24 JAN 31 JAN WED FRI WED Benign cellular changes and specific infections in cervical smear Virtual interactive slide session Dr. Sanjay Gupta, Ex-Sci G, ICMR-NICPR Dr. Shalini Singh, Director, ICMRNICPR

19th January 2023 –

Collection of cervical smear, Uniform approach to reporting cervical cytology (Bethesda 2014), Normal cervical smear Dr. Neelam Sood DDU Hospital, Delhi

24th January 2023 –

Benign cellular changes and specific infections in cervical smear Virtual interactive slide session Dr. Sanjay Gupta, Ex-Sci G, ICMR-NICPR

31st January 2023 –

Cervical Cancer Pathogenesis: HPV and beyond Dr. Radhika Srinivasan, PGIMER, Chandigarh

2nd February 2023 –

Atypical Squamous Cells ( ‘ASC’) & ‘Low grade squamous intraepithelial lesions’: patterns & pitfalls Virtual interactive slide session Dr. Sanjay Gupta

7th February 2023 –

Cytology of ‘High-grade squamous lesions of the cervix’ (ASC-H, HSIL, and SCC): patterns and pitfalls Virtual interactive slide session Dr. Sanjay Gupta

9th February 2023 –

Glandular lesions of the cervix: cytomorphologic spectrum and discussion of interesting cases Dr. Neeta Kumar, New Delhi

14th February 2023 –

Liquid-based cytology in cervical pathology – specific infections and epithelial abnormalities Prof. Nalini Gupta, PGIMER, Chandigarh

16th February 2023 –

Grossing techniques relevant to cervical pathology. Histopathologic panorama of cervical precancerous lesions and carcinoma Dr. Sonal Sharma, UCMS & GTB Hospital, Delhi

21st February 2023 –

Cyto-histological correlation in cervical pathology: The ASC guidelines Dr. Ruchika Gupta, ICMR-NICPR

23rd February 2023 –

HPV & other biomarkers in cervical cancer prevention Dr. Pooja Bakshi, Sir Ganga Ram Hospital, New Delhi

28th February 2023 –

Artificial Intelligence in Cervical Cytology Dr. Ruchika Gupta

Medicolegal aspects in cervical smear reporting Dr. Shamsuz Zaman, ICMR-NICPR

1st March 2023 –

Concluding session – participants’ feedback. Dr. Ruchika Gupta, Dr. Shamsuz Zaman

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/5thcoursebrochure-228115.pdf

Also Read:MCC NEET SS Counselling Round 2 Begins Today, Register now

Powered by WPeMatico

Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan

New Delhi: In response to the proposal for bioequivalence (BE) study and Phase III clinical trial (CT) waiver for Sacubitril 12mg plus Valsartan 13mg film-coated tablets presented by the drug major Alkem Laboratories, the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit more justification on the proposed dose and rationality of the fixed-dose combination of Sacubitril plus valsartan.

This came after Alkem Laboratories presented their proposal along with justification for the BE waiver and Phase III CT waiver before the committee.

Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Sacubitril’s active metabolite, LBQ657 inhibits neprilysin, a neutral endopeptidase that would typically cleave natriuretic peptides, which includes: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP). ANP and BNP are released under atrial and ventricle stress, which activate downstream receptors leading to vasodilation, natriuresis, and diuresis. Under normal conditions, neprilysin breaks down other vasodilating peptides and vasoconstrictors such as angiotensin I and II, endothelin-1, and peptide amyloid beta-protein. Therefore, the inhibition of neprilysin leads to reduced breakdown and increased concentration of endogenous natriuretic peptides in addition to increased levels of vasoconstricting hormones such as angiotensin II.

Valsartan is an angiotensin-receptor blocker used to manage hypertension alone or in combination with other antihypertensive agents and to manage heart failure in patients who are intolerant to ACE inhibitors.

Valsartan belongs to the angiotensin II receptor blocker (ARB) family of drugs, which selectively bind to angiotensin receptor 1 (AT1) and prevent angiotensin II from binding and exerting its hypertensive effects.

At the recent SEC meeting for cardiovascular and renal held on 6th and 7th December 2023, the expert panel reviewed the proposal along with justification for BE waiver and Phase III CT waiver of the FDC Sacubitril plus Valartan presented by Alkem Laboratories.
After detailed deliberation, the committee opined, “More justification on the proposed dose and its rationality should be submitted for further review by the committee.”

Powered by WPeMatico

Intrarectal Botox Injections Promising for Treatment of Faecal Incontinence

A recent randomized, double-blind, placebo-controlled study has revealed compelling evidence supporting the efficacy of intrarectal injections of botulinum toxin type A (BoNTA) in treating urge faecal incontinence. This five-year study, conducted by a team from eight specialized French hospitals, aimed to evaluate the effectiveness of BoNTA injections compared to a placebo in adult patients experiencing at least one weekly episode of urgency or faecal incontinence for a minimum of three months, despite prior conservative or surgical treatments. The study was published in the Lancet Gastroenterology and Hepatology journal.

Between November 2015 and November 2020, 200 patients were randomly assigned to receive either BoNTA (n=100) or a placebo (n=100). Following withdrawals before injections, 96 patients received BoNTA, and 95 patients received the placebo. The primary endpoint was the number of faecal incontinence and urgency episodes per day, assessed using 21-day patient bowel diaries three months after treatment.

The findings revealed a significant decrease in the mean number of episodes in the BoNTA group from 1.9 at baseline to 0.8 at 3 months post-injections, compared to a decrease from 1.4 to 1.0 in the placebo group. The adjusted mean group difference at 3 months was estimated at -0.51 (95% CI -0.80 to -0.21, p=0.0008), highlighting the remarkable effectiveness of BoNTA injections.

The study demonstrated no serious treatment-related adverse events. Constipation was the most frequently reported non-serious adverse event, observed in 40% of patients receiving both BoNTA and placebo injections.

Lead researcher Anne-Marie Leroi, PhD, highlighted the significance of BoNTA injections as an efficacious treatment for urge faecal incontinence. Despite these promising results, further research is warranted to optimize selection criteria, dosage, injection site, frequency of re-injection, and long-term outcomes.

These findings mark a significant advancement in the treatment landscape for faecal incontinence, offering hope to individuals who have faced challenges with existing treatment options. The study’s success in significantly reducing episodes of faecal incontinence and urgency with minimal adverse effects positions BoNTA injections as a potential breakthrough therapy in this field.

The study’s results could pave the way for further research aiming to refine treatment protocols and assess the sustained effectiveness of BoNTA injections in managing urge faecal incontinence, ultimately improving the quality of life for affected individuals.

Reference:

Leroi, A.-M., Queralto, M., Zerbib, F., Siproudhis, L., Vitton, V., Amarenco, G., Etienney, I., Mion, F., Bridoux, V., Philip, J., Brochard, C., Damon, H., Lacroix, E., Gillibert, A., & Gourcerol, G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. The Lancet. Gastroenterology & Hepatology,2023. https://doi.org/10.1016/s2468-1253(23)00332-1

Powered by WPeMatico

68 Vacancies For SR Post: Walk In Interview At AIIMS Kalyani, Apply Now

Kalyani: The All India Institute of Medical Sciences Kalyani (AIIMS Kalyani) has released Vacancies for Senior Residents (Non-academic) post on a contract basis in various dept.

All India Institute of Medical Sciences, Kalyani under the Ministry of Health and Family Welfare, Govt. of India, has been established as an Institute of National Importance and is one of the new upcoming AIIMS and apex healthcare Institutes being selected by the Ministry of Health & Family Welfare, Government of India under the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) with the aim of correcting the regional imbalance in quality tertiary level healthcare in the country, and attaining self-sufficiency in graduate, postgraduate and higher medical education and training.

AIIMS Kalyani Vacancy Details:
Total No of Vacancies: 68

The Vacancies are in the Departments of Anesthesiology, Anatomy, Biochemistry, Community & Family Medicine, Dermatology, ENT, Forensic Medicine and Toxicology, Microbiology, Nuclear Medicine, Obstetrics and Gynecology, Ophthalmology, Physiology, Pediatrics, Radiology, Transfusion Medicine & Blood Bank, Trauma & Emergency Medicine, General Surgery, and General Medicine.

Date of Walk-In-Interview – 26th December 2023.

Venue: Administrative Building, 1st, Floor, Committee Room of AIIMS, Kalyani, Pin -741245.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:

If the interview is not completed in a stipulated day and time, the candidate may have to attend the same on subsequent day. Documents to be bought in original with one set photocopy:

1. Proof of Date of Birth – Xth Admit/ marksheet/ certificate/ Birth Certificate

2. 12th certificate

3. MBBS certificate and marksheets

4. MD / DNM passing certificate

5. NMC Registration certificate;

6. NOC from current employer,

7. category certificate,

8. experience certificate

Also Read:SR Post Vacancies: Walk in interview At AIIMS Kalyani, View All Details Here

Powered by WPeMatico

BMC Hospitals OPD to start at 8 AM now, biometric must for doctors

Mumbai: The Brihanmumbai Municipal Corporation (BMC) on Tuesday directed all major hospitals in Mumbai to implement the biometric system which will be linked to doctors’ salary, aiming to reduce long queues of patients.

Meanwhile, a biometric fingerprint system has also been installed in hospitals on Wednesday.

According to the circular, it states “Commencing at 8:00 am, all major medical municipal hospitals will enforce mandatory biometric registration for doctors upon entry and exit. This biometric attendance system will be intricately tied to the salary of every doctor through SAP”.

Also Read: Mumbai doctor accuses Sajjan Jindal of rape, sexual assault for two years; Steel group baron denies allegations

This initiative was taken after the visit of Additional Municipal Commissioner Dr Sudhakar Shinde to several municipal hospitals on Tuesday. During the visit, he observed a huge queue at the OPD for registration and consultation with doctors. Speaking to the Indian Express Dr Shinde said, “We are streamlining the process. Introducing biometric attendance will enhance transparency regarding the availability of doctors. Moreover, with early registrations, we anticipate a reduction in lengthy queues at the OPD”.

The move has been initiated due to inconsistency in the attendance of doctors, leading to delays in the morning outpatient department (OPD) schedule. Late arrival of doctors at the hospital causes inconvenience to patients coming from far-flung areas like Palghar and Navi Mumbai. It has been observed that KEM, Sion, Nair and Cooper hospitals receive more than 10,000 patients from different parts of Maharashtra. Of these, 40% of these patients come from outside Mumbai. “We received complaints about patients facing long waiting periods in OPDs due to delays in starting the OPD. We have instructed the deans to ensure the biometric system is followed and OPDs are started on time”, mentioned Dr Shinde to Hindustan Times.

Also Read: AstraZeneca Pharma India launches Centre of Excellence for severe asthma in Mumbai

However, according to officials, biometric facilities were already there in the hospitals but it was stopped during the Covid-19 pandemic. On this, Dr Neelam Andrade the director of major civic hospitals, said “The biometric was earlier not linked to the salary. If the doctor reports late to the OPD, it will now directly affect their salary”.

On the first day after the implementation of the plan, the crowd of patients in the hospital reduced by noon, which usually remained even after 1 pm. Due to this, patients often had to return from the hospital as the OPD timings used to get over. Besides, all the washrooms in the OPD building were also cleaned.

Many complaints have been received from the patients regarding the late arrival of doctors, especially senior doctors, in OPD. It has been alleged that many senior doctors maintain private clinics close to the hospitals where they work. They often reached the OPD early and left before time, leaving the entire workload on the junior resident doctors. When Indian Express asked Dr Sudhakar Shinde on this matter, he said, “We will initiate serious action if such allegations are proven.”

Also Read: All-women team at Mumbai civic hospital performs complex Cesarean on woman with stuck placenta

Powered by WPeMatico

Female Patient Death Case: GMC suspends doctor’s licence for three months

Ahmedabad: Taking action against a Surat-based doctor from Guru Nanak Hospital, the Gujarat Medical Council (GMC) has suspended his licence for three months for his alleged negligent approach while treating a patient, who ultimately died.

Even though the patient, who was initially taken to the hospital for treatment of common cold and fever, was physically weak, saline bottles were administered to her. Consequently, her condition worsened resulting in heart failure.

The Gujarat Medical Council (GMC), decided on suspension after the panel comprising the president of the Council Dr. Nitin Vora interviewed the treating doctor and opined that the casual treatment approach on the part of the doctor resulted in the death of the patient, adds TOI.

Therefore, the treating doctor is now facing cancellation of his license for medical practice for three months. According to a GMC statement, the registration of the treating doctor was revoked on Friday based on a complaint by the mother of the deceased patient.

Also read- Patient’s Death Case At GMCH Chandigarh: No Medical Negligence, Says Hospital Panel

As per the latest media report by the Times of India, the matter goes back to January 07, when the patient was admitted to the Guru Nanak Hospital for a common cold and fever. The treating doctor diagnosed the patient with tuberculosis. Consequently, the patient was administered 4-5 injections and seven saline bottles.

It was alleged by the complainant that another doctor while checking the patient previously had mentioned that the girl was physically weak. The concerned doctor had also warned about the possibility of heart failure if the patient was administered saline.

The complainant alleged that even though this instruction was conveyed to the treating doctor and the staff of the hospital, saline bottles were administered to the girl.

In her complaint, the patient’s mother mentioned that the condition of her daughter gradually worsened on January 8. However, the staff of the hospital allegedly took no action. 

Following this, on January 9, the girl started having difficulty in breathing and when she could not move to the washroom, the treating doctor was called immediately. Consequently, the treating doctor performed CPR. However, the patient suffered heart failure.

Although she was transferred to Surat-based Unique Hospital and was placed on a ventilator, she could not be saved and declared dead on January 10.

Based on the complaint of the deceased patient’s mother, the GMC panel led by its president interviewed the treating doctor. Consequently, the panel opined that the treating doctor’s casual treatment approach resulted in the death of the patient. Therefore, taking action against the doctor, the Council suspended his licence for medical practice for three months. 

Also read- Newborn Dies After C-Section: Doctor Accused Of Medical Negligence, Booked

Powered by WPeMatico

GSK enters exclusive license agreement with Hansoh for HS-20093

London: GSK plc and Hansoh Pharma, a Chinese biopharmaceutical company have announced that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload.

Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093.

Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said, “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.”

This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours. HS-20093 is currently being investigated in ongoing phase I and II trials in China. Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile.

Eliza Sun, Executive Director of Board, Hansoh Pharma, said, “HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.”

GSK plans to begin phase I trials for HS-20093 outside of China in 2024.

In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours.

Under the terms of this agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialisation of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan.

This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

Read also: Jemperli plus Zejula combo significantly improved progression-free survival in primary advanced or recurrent endometrial cancer: GSK

Powered by WPeMatico