Study Safety and Efficacy of Tenecteplase 0.25 mg/kg in Acute Ischemic Stroke: CDSCO Panel Tells Boehringer Ingelheim

New Delhi: Rejecting the drug major Boehringer Ingelheim’s request for waiver of the local clinical trial of Metalyse 25 mg (tenecteplase 0.25 mg/kg) for the additional indication, acute ischemic stroke (AIS), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct a phase III study in Indian patients to establish the safety and efficacy of the drug for AIS indication with the proposed dose of 0.25mg/kg.

This came after Boehringer Ingelheim India presented the proposal for approval of additional indications for the drug Metalyse 25 mg (tenecteplase 0.25 mg/kg) lyophilized powder for solution for injection based on the clinical data generated from the global clinical studies conducted for Acute Ischemic Stroke (AIS) with the request of local clinical trial waiver.

The committee noted that a dose of 0.2mg/kg for the drug is approved in India for AIS indication for another manufacturer. However, the firm has proposed a higher dose i.e. 0.25mg/kg for the drug which is not approved in India.

Tenecteplase is a modified form of recombinant human tissue plasminogen activator used in the emergency treatment of myocardial infarction and pulmonary emboli. Tenecteplase is an FDA-approved medication specifically indicated for reducing mortality in patients with ST-elevation acute myocardial infarction (STEMI). Off-label indications include thrombolysis in treating acute ischemic stroke, pulmonary embolism, and central venous catheter clearance.

Tenecteplase binds to fibrin-rich clots via the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.

At the recent SEC meeting for neurology and psychiatry held on the 18th and 19th of January 2024, the expert panel reviewed the proposal for approval of additional indications for the drug Metalyse 25 mg (tenecteplase 0.25 mg/kg) lyophilized powder for solution for injection.

After detailed deliberation, the committee did not consider the firm’s request for waiver of the local clinical trial and recommended the firm conduct a Phase III study in Indian patients to establish the safety and efficacy of the drug for acute ischemic stroke (AIS) indication with the proposed dose of 0.25mg/kg.

Also Read: Windlass Biotech gets CDSCO Panel Nod To Manufacture, Market Ezetimibe plus Atorvastatin Calcium tablet

Powered by WPeMatico

Doctor dismissed for pre-wedding shoot inside Hospital OT

The idea of holding a pre-wedding shoot inside a government-run hospital, proved heavy for a young doctor Dr Abhishek, after he was dimissed from his duty as his shoot went viral on social media.

A doctor was dismissed from service on Friday soon after a video of his pre-wedding photo shoot held inside an operation theatre of a government-run hospital in Karnataka’s Chitradurga district went viral, officials said.

For the full story, check out the link given below:

OOPS : Doctor Holds Medical Procedure-Based Pre-Wedding Shoot Inside Govt Hospital OT, Dismissed

Powered by WPeMatico

PG medicos compelled to stay in hostel, NMC warns medical colleges

Through a recent notice, the National Medical Commission (NMC) has issued a warning for medical colleges concerning the hostel accommodation for PG Medical students. The notice comes after the NMC received several complaints from students that hostels or medical institutions are compelling them to stay in the hostel and a hefty amount is being charged for the same.

As per the notice, the medical colleges will be penalised as per Regulations 9.1 and 9.2 of the PGMER, 2023 which includes monetary penalty, reduction of seats, stoppage of admission etc if they found ‘compelling the PG medicos to stay in the hostel offered by the Medical Colleges/ Institutions and charging a hefty amount.’

According to NMC regulations, hostel accommodation for postgraduate medical students is optional.

For the full story, check out the link given below:

NMC Slams Medical Colleges For Compelling PG Medicos To Stay In Hostel, Warns Of Strict Action

Powered by WPeMatico

Deadline to submit feedback on NMC National Exit Test Regulations 2023 extended

The National Medical Commission (NMC) has extended the deadline for submitting feedback on the NMC National Exit Test Regulations, 2023 by 10 days.

Earlier the Apex Medical Commission had asked the stakeholders to submit their comments/suggestions/feedback on the rules for conducting the proposed National Exit Test (NExT) by 07.02.2024. However, now the Commission has extended the deadline till 17.02.2024.

For the full story, check out the link given below:

NMC Extends Deadline For Submitting Comments On National Exit Test Regulations 2023

Powered by WPeMatico

GB Pant Hospital Vacancies: Assistant Professor Post In Various Specialties, Apply Now

New Delhi: Govind Ballabh Pant Institute of Postgraduate Medical Education and Research (GIPMER) has notified vacancies for the Assistant Professor post on a contract basis in this medical institute.

The Institution has a unique recognition by the Medical Council of India and the University Grants Commission as an independent post-graduate College affiliated with Delhi University. the Foundation stone of Govind Ballabh Pant Hospital was laid in October 1961 and was commissioned by the then Prime Minister late Pt. Jawaharlal Nehru on 30th April 1964. From a very humble beginning with 229 beds, it has expanded to currently over 700 beds (714 beds). Today it is an internationally recognized tertiary care institution for Heart, Brain Gastrointestinal, and Psychiatric disorders. It offers super specialty treatment to about 3 lac patients in the OPD and almost 15,000 patients in General and Private wards yearly.

GIPMER Vacancy Details:

Total no of vacancies: 22

The vacancies are in the Departments of Cardiology, Gastroenterology, Neurosurgery, Neurology, Anesthesiology, and Pathology.

The last date of submission of the Application is 15th February 2024.

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=GB+Pant+Hospital&location=&job_sector=all

How to Apply For Eligible Candidates:-

The application complete in all respect must reach the Academic Cell, 5th Floor, D Block, G.B. Pant Institute by 15th February 2024 upto 10:00 AM. The format of application, eligibility criteria and other details are available on the website of this institute i.e. http://gbpant.delhi.gov.in The incomplete application shall be summarily rejected. Walkin-interview shall be held on 15th February, 16th February 2024

The eligible and desirous candidates fulfilling educational qualification/eligibility condition to submit the application form with one set of attested photocopy of the relevant documents in support of Age, Qualification, Mark sheet, Degree, Category, Experience & Three passport size photographs and a demand Draft of Rs. 1000/- (for SC/ST candidates Rs.300/-) (Non Refundable) payable at Delhi/ New Delhi (issued by the Bank after the date of publication of advertisement) in favour of “MEDICAL SUPERINTENDENT, G B PANT HOSPITAL” or through Cash(To be deposited with Cashier, G B Pant Institute). No TA/DA will be paid to the candidates. In case of any legal dispute the Jurisdiction of Court will be Delhi/New Delhi.

Powered by WPeMatico

Health Bulletin 10/February/2024

Here are the top health stories for the day:

NMC extends deadline for public input on National Exit Test regulations 2023

The National Medical Commission (NMC) has extended the deadline for submitting feedback on the NMC National Exit Test Regulations, 2023 by 10 days.

Earlier the Apex Medical Commission had asked the stakeholders to submit their comments/suggestions/feedback on the rules for conducting the proposed National Exit Test (NExT) by 07.02.2024. However, now the Commission has extended the deadline till 17.02.2024.

For the full story, check out the link given below:

NMC Extends Deadline For Submitting Comments On National Exit Test Regulations 2023


NMC issues stern warning to medical colleges over forcing PG medicos into hostel stay

Through a recent notice, the National Medical Commission (NMC) has issued a warning for medical colleges concerning the hostel accommodation for PG Medical students. The notice comes after the NMC received several complaints from students that hostels or medical institutions are compelling them to stay in the hostel and a hefty amount is being charged for the same.

As per the notice, the medical colleges will be penalised as per Regulations 9.1 and 9.2 of the PGMER, 2023 which includes monetary penalty, reduction of seats, stoppage of admission etc if they found ‘compelling the PG medicos to stay in the hostel offered by the Medical Colleges/ Institutions and charging a hefty amount.’

According to NMC regulations, hostel accommodation for postgraduate medical students is optional.

For the full story, check out the link given below:

NMC Slams Medical Colleges For Compelling PG Medicos To Stay In Hostel, Warns Of Strict Action

Doctor dismissed for pre-wedding photoshoot in government hospital operating room

The idea of holding a pre-wedding shoot inside a government-run hospital, proved heavy for a young doctor Dr Abhishek, after he was dimissed from his duty as his shoot went viral on social media.

A doctor was dismissed from service on Friday soon after a video of his pre-wedding photo shoot held inside an operation theatre of a government-run hospital in Karnataka’s Chitradurga district went viral, officials said.

For the full story, check out the link given below:

OOPS : Doctor Holds Medical Procedure-Based Pre-Wedding Shoot Inside Govt Hospital OT, Dismissed

Powered by WPeMatico

No new concerns raised by USFDA staff about Abbott heart device

The U.S. Food and Drug Administration (FDA) staff reviewers did not raise any new concerns over the safety and effectiveness of Abbott’s heart valve repair device designed for patients who are at risk for surgery.

The assessment comes ahead of the FDA’s independent expert panel meeting on Tuesday, which will make recommendations on whether or not to clear the use of the device, TriClip, in patients with tricuspid regurgitation (TR).
TR is a disorder in which the tricuspid valve that separates the right lower heart chamber from the right upper heart chamber does not close tight enough, potentially causing heart failure.
About 1.6 million Americans are estimated to have the disorder, according to government data.
The FDA, however, noted that there was no signal of reduced deaths or hospitalizations in patients who received the implant compared to those who were on medical therapy.
“With limited alternatives, we think this alone should be enough to drive approval and adoption despite the lack of a mortality or hospitalization benefit, which the overall tone and substance of the briefing documents are supportive of as well,” J.P.Morgan analyst Robbie Marcus wrote in a note.
The device, already approved in more than 50 countries, is inserted through the femoral vein in the leg and is then guided and clipped on to the tricuspid valve.
The FDA had approved a similar device from rival Edwards Lifesciences earlier this month to treat patients with TR.
Abbott’s application is based on data from a late-stage study in which TriClip was shown to significantly improve patients’ quality of life.
Read also: Abbott Labs must face lawsuit over PediaSure height claims

Powered by WPeMatico

NExT exam evaluation criteria must be moderate, allocate ample time for preparation, release schedule early: Parliamentary panel tells Health Ministry

New Delhi: After the recent suggestion from the Indian Medical Association (IMA) to reconsider the implementation of the National Exit Test (NExT) exam, a parliamentary committee has recommended to the Union Ministry of Health and Family Welfare to thoroughly examine the implications of NExT exam, which will serve as a common qualifying final-year MBBS exam, a licentiate exam to practise modern medicine and also as the gateway to get admission to postgraduate medical courses.

Besides, the Parliamentary panel has also advocated for due diligence in addressing the concerns of all the relevant stakeholders, reports PTI. The committee recommended that the government allocate ample time for thorough preparation and provide an early release of the exam schedule, along with other relevant details regarding the examination.

This will enable the first batch of candidates to prepare adequately and smoothly transition to the new examination format. Additionally, considering the diverse background of medical colleges from which the first batch of NExT aspirants would come, the committee suggested that the evaluation criteria should be moderate.

In its report, which was tabled in the Parliament this week, the panel mentioned, “It is imperative to ensure that no group of graduates faces an undue advantage or disadvantage in the examination. Striking a fair and equitable balance in the evaluation process will be pivotal in ensuring the success and fairness of the NExT exam.”

The panel noted that the assessment of medical graduates would ensure that all medical graduates have a uniform level of knowledge and skills, regardless of where they studied.

“This improves the quality of medical education and training in India and makes the process of licensure and postgraduate admissions more transparent and fairer,” said the panel.

The issue of the NExT exam has been making waves in the medical fraternity ever since its first announcement. Although last year NMC released the NExT regulations and announced conducting the exam for the 2019 MBBS batch, it was ultimately put on hold for an indefinite time.

Thereafter, the Union Health Ministry has constituted a seven-member committee to look into the preparedness of States and medical colleges for the implementation of the exam for the final year MBBS students of the 2020 batch.

Amidst the debate and uncertainty regarding the conduct of NExT exam, NMC made the issue open to all the stakeholders. Recently, issuing a notice, NCM asked the stakeholders to submit their feedback on the NMC National Exit Test Regulations, 2023 by 07.02.2024. The deadline was further extended by the Commission till 17.02.2024.

Also Read: Reconsider implementation of National Exit Test: IMA to NMC

Meanwhile, recently, submitting its feedback on the NEXT examination, the Indian Medical Association (IMA) has opposed the Commission’s plans for conducting the exam as it opined that since the standards of medical education across all academic institutions vary, testing the entire country with one test would not be “feasible”.

In a letter addressed to the Chairman of NMC, Dr B.N.Gangadhar, the association highlighted that the medical colleges across the country are facing inadequate technical infrastructure, and faculty training and support. Therefore, IMA stated that NMC should not proceed with NExT until these prerequisites are duly satisfied.

Now, a parliamentary committee has also recommended to the Union Health Ministry to thoroughly examine the implications of NExT Exam and advocated for due diligence in addressing the concerns of all the relevant stakeholders.

Further, the panel stated that in addition to standardised final assessment of graduates, there is an urgent need to universalize or standardise undergraduate and postgraduate education.

Reputed institutes like AIIMS impart different quality of medical education while newly opened medical institutes need such quality.

Keeping this in view, it recommended the government to divide India into zones, and in each zone reputed institutes like AIIMS can function as mentor institutes for all the other medical colleges in that zone.

Mentor institutes shall play a significant role in monitoring the standard of education and the classes in the newly set medical colleges or private medical colleges, it said.

The committee further recommended that the National Medical Commission (NMC) should address the inconsistencies in granting permanent registration to foreign medical graduates across various states.

The FMG Regulations 2021 are a pivotal framework to maintain and uphold the quality of medical professionals in India.

“However, these regulations must adopt a facilitative role rather than imposing unwarranted obstacles in the registration and internship process for foreign medical graduates,” it observed.

The panel recommended the NMC to strike a balance between quality assurance and inclusivity, ensuring that bureaucratic or procedural impediments do not unduly burden foreign medical graduates who meet the necessary standards.

By acting as facilitators, regulatory authorities can streamline the registration and internship procedures, enhancing the integration of foreign medical graduates into the Indian healthcare system, it said in the report.

Further to address the issue of ghost faculty and ensure that the available faculty comes to the college to teach, the committee recommended to the government to strictly enforce the regulations already in place to curb the problem of ghost faculty and zero attendance.

The NMC should conduct regular inspections of medical colleges and take action against colleges that are found to be violating the regulations, it stressed.

Also Read: NMC Extends Deadline for Submitting Comments on National Exit Test Regulations 2023

Powered by WPeMatico

MCC declares final results of NEET SS Counselling special round

New Delhi- The Medical Counselling Committee (MCC) has declared the final results of the candidates who appeared for the NEET Super Specialty (SS) Counseling 2023 special round for D.M, M.Ch and DNB SS courses.

The list includes rank, allotted institute, course, remarks, qualifying exam and option number. This is the combined result of all the rounds i.e. Round 1, 2 and 3.

Earlier, MCC had declared the provisional results.

The special round of SS counselling was held on 7 February 2024. It was conducted to fill the remaining vacant DM, M.Ch and DNB SS seats after Round 2 of AIQ SS Counseling 2023.

The Medical Counselling Committee (MCC) is an organisation under the Directorate General of Health Services (DGHS) affiliated to the Ministry of Health and Family Welfare, Government of India and responsible for allotting seats for undergraduate, postgraduate and super-speciality medical and dental courses in government-run/aided colleges and deemed-to-be-university colleges.

To view the result, click the link below-

Powered by WPeMatico

AstraZeneca-Ionis Eplontersen granted USFDA fast track designation for transthyretin-mediated amyloid cardiomyopathy

Carlsbad: Ionis Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ionis and AstraZeneca’s eplontersen, an investigational therapy for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults. The FDA grants development programs Fast Track designation to facilitate the development and expedite the review of drugs that demonstrate the potential to treat serious conditions and fill an unmet medical need.

“Receiving Fast Track designation from the FDA reinforces our belief that eplontersen has the potential to be a transformational treatment for patients with ATTR-CM, which remains a progressive and fatal condition for hundreds of thousands of people worldwide despite available treatment options,” said Eugene Schneider, M.D., executive vice president and chief clinical development officer, Ionis. “CARDIO-TTRansform is the largest, most comprehensive study ever conducted in ATTR-CM patients, with results expected as early as next year.”

Sarah Walters, vice president, U.S. cardiovascular, renal and metabolic diseases, AstraZeneca said, “We are committed to accelerating innovation and addressing the spectrum of unmet patient needs in amyloidosis. Together with our partner Ionis, AstraZeneca is building on our heritage in cardiovascular disease and RNA-targeted therapeutics to bring a potential best-in-class treatment for people living with ATTR-CM.”

In December 2023, eplontersen was approved in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN, under the brand name WAINUA (eplontersen). As part of a global development and commercialization agreement, AstraZeneca and Ionis are commercializing WAINUA for the treatment of ATTRv-PN in the U.S. and are seeking regulatory approval in Europe and other parts of the world. WAINUA was granted Orphan Drug Designation in the U.S. and in the EU for the treatment of transthyretin-mediated amyloidosis (ATTR).

The global CARDIO-TTRansform Phase 3 study of eplontersen in adults with ATTR-CM is fully enrolled with more than 1,400 patients – making it the largest study in this patient population to date. The company plans to share data from the CARDIO-TTRansform study as early as 2025.

Read also: AstraZeneca Enhertu granted priority review in US for metastatic HER2-positive solid tumours

Powered by WPeMatico