USFDA nod to first Nasal Spray for Anaphylaxis

U.S. Food and Drug Administration has approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).

“The approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.”

Allergic reactions happen when a person’s immune system reacts abnormally to a substance that normally does not cause symptoms. Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Common allergens that can induce anaphylaxis include certain foods, medications and insect stings. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection.

Neffy’s approval is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis. A study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.

Neffy is a single dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, and patients with these conditions should consult with a health care professional to consider use of an injectable epinephrine product. Neffy also comes with warnings and precautions about use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite.

The most common side effects of neffy include throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting.

The FDA granted neffy Fast Track designation for this application.

The FDA granted the approval of neffy to ARS Pharmaceuticals.

Read also: Major depressive disorder drug: USFDA nod to Granules India Trazodone Hydrochloride Tablets

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Dr. Reddy’s Lab gets CDSCO Panel nod to study Semeglutide injection

New Delhi: In line with the bioequivalence study report of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) (Synthetic Origin) presented by the drug major Dr Reddy’s Lab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to conduct a Phase III clinical trial of Semaglutide Injection as per the protocol presented.

In addition, the expert panel opined that the firm submit the results for further deliberation.

This came after Dr. Reddy’s lab presented the bioequivalence study report and the Phase-III clinical trial protocol before the committee.

Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.

GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone, such as semaglutide, stimulate the synthesis of insulin3 by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.

Earlier, at 106 the SEC meeting held on 27.09.2023 and 29.09.2023, the firm had presented Bioequivalence protocol and Justification for Phase-III clinical trial waiver before the committee. Responding to this, the expert panel had stated that Phase-III clinical trial waiver can be considered based on the review of the bioequivalence study report by the SEC committee.

Now in line with the above, at the recent SEC meeting for Endocrinology and Metabolism held on July 24, 2024, the expert panel reviewed the bioequivalence study report along with the Phase-III clinical trial protocol of the Semaglutide Injection presented by the drug major Dr Reddy’s Lab.

After detailed deliberation, the committee considered the bioequivalence report and recommended the grant of permission to conduct a phase III clinical trial study as per the protocol presented and further stated to submit the results for further deliberation.

Also Read: Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan

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Authorise enough centres for NEET PG 2024 exam in every state: Shashi Tharoor urges Health Minister Nadda

Amid the row over NEET PG 2024 exam centre allocation, the Congress MP Shashi Tharoor has written to the Union Health Minister J P Nadda urging for the authorisation of enough exam centres in every state on August 11 so that students do not have to travel thousands of kilometres and will be able to avoid the hassle of arranging affordable and safe accommodation.
In a letter to Nadda that Tharoor posted on X, the Congress leader also drew the minister’s attention to reports that the number of cities in which the tests are to be conducted has been reduced significantly.
For more information, click on the link below:

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On-duty doctor, 2 nurses assaulted by patient at Aundh District Hospital

Pune: A patient, reportedly under the influence of
alcohol, allegedly assaulted two nurses and a doctor at Aundh District
Hospital on Saturday. The accused was brought to the hospital by an ambulance exhibiting disruptive behaviour.

This incident marks the second time that hospital staff have been subjected to such violence in the past six months in
Pune. Officials have mentioned that this incident has caused panic among
the staff and raised security concerns about the hospital premises.

On Saturday around noon, from Sangavi, a patient was brought
into the hospital by an ambulance and became disruptive and allegedly
intoxicated. The man began verbally and physically abusing the
staff of the hospital. He allegedly assaulted two nurses and a doctor at Aundh
District Hospital. Although, there is a police chowky, on the hospital premises
but no policeman was stationed at that chowky at the time of the incident.

Also Read:Mumbai: Drunk Patient attacks doctor with knife, slashes arm

According to the HT, Dr Nagnath Yempalay,
district civil surgeon, said, “We have requested the police staff following the
recent incident where a male doctor and several nurses were verbally and
physically assaulted by an intoxicated patient. Also, there is a need for
police staff stationed regularly at the hospital to avoid such incidents.
However, despite several letters requesting it, there has been no response.”

In the past six months, this is the second time that
hospital staff have been subjected to such violence. The previous incident
involved an unknown visitor who damaged the hospital furniture, such as the
glass and table. Fortunately, the security staff prevented any major disaster
that day, said doctor Yempalay. He also mentioned the need for security and
police intervention in the hospital premises to ensure the safety of both staff
and patients.

A senior doctor speaking on the incident of violence has
expressed his concerns about the security of the hospital and has talked about
the need to increase police involvement to enhance the security system. He
mentioned, “The security at the hospital is inadequate, with only 21 security
guards. Seven security guards are there during the night shift which is
insufficient considering the huge hospital area and wards. There is no proper
lighting inside the hospital campus. The boundary wall of the hospital is
broken with huge trespassing,”

However, Mahesh Bansode Senior police Inspector at Sangavi
police station assured police officials are stationed at the police chowky
in the hospital. “However, if there are instances where they are not present
during their office hours, I will investigate the matter. We will ensure that
proper arrangements are made for policemen to be stationed at the
hospital,” he said.

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BFUHS invites applications for NEET 2024 counselling

Baba Farid University of Health Sciences (BFUHS) is inviting online applications for combined online counselling from eligible candidates on the basis of National Eligibility and Entrance Test-Undergraduate (NEET UG) 2024 for admission to UG Medical and Dental Courses in Government and Private Colleges and Minority Institutions in the state of Punjab.
The registration for combined online counselling for NEET UG 2024 has started and will end on August 15, 2024. Meanwhile, the 1st round of online counselling will begin on August 10 and will continue till September 05, 2024. The detailed schedule of the registration process and counselling of NEET UG 2024 is mentioned below-
For more information, click on the link below:

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Doctor transferred despite appointment being non-transferrable! High Court slams DME for violating service terms, slaps compensation

The Madhya Pradesh High Court recently asked the Director of Medical Education (DME) to pay Rs 25,000 as cost while considering a plea by a doctor who was transferred for a second time in violation of the terms of her service.
Quashing the transfer order, the HC bench comprising Justice Vishal Mishra clarified the amount of cost has to be paid by the Director of Medical Education out of his pocket.
For more information click on the link below:

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Health Bulletin 10/ August/ 2024

Here are the top health stories for the day:

Supreme Court rejects plea to postpone NEET PG 2024
The Supreme Court dismissed the plea seeking a postponement of the National Eligibility-and-Entrance Test Postgraduate (NEET-PG) 2024 examination, scheduled to take place on August 11, 2024.
Filing the plea before the Supreme Court, the petitioners highlighted the inconvenience faced by the candidates who were allocated test cities far away from their home.
For more information, click on the link below:
Kolkata Tragedy: PG chest medicine student at RG Kar Hospital found dead, doctors demand CBI probe
In a shocking incident in Kolkata, a second-year postgraduate medical student at the Chest Medicine Department of R.G. Kar Medical College and Hospital was found dead under mysterious circumstances.
While it is still unclear what happened to the doctor and what led to her death, her half-naked body was recovered from the seminar hall, Kolkata TV has reported.
For more information, click on the link below:
NEET PG 2024 exam centre controversy: Shashi Tharoor urges Health Minister Nadda to ensure adequate centres in every state
Amid the row over NEET PG 2024 exam centre allocation, the Congress MP Shashi Tharoor has written to the Union Health Minister J P Nadda urging for the authorisation of enough exam centres in every state on August 11 so that students do not have to travel thousands of kilometres and will be able to avoid the hassle of arranging affordable and safe accommodation.
In a letter to Nadda that Tharoor posted on X, the Congress leader also drew the minister’s attention to reports that the number of cities in which the tests are to be conducted has been reduced significantly.
For more information, click on the link below:

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MBBS, BDS Admissions 2024 begin in Andhra Pradesh: NTRUHS releases fee structure, eligibility criteria for candidates

Andhra Pradesh- Dr NTR University of Health Sciences (NTRUHS) is inviting online application form and uploading of scanned original certificates for Admission into undergraduate MBBS and BDS Courses for the seats available under Competent Authority Quota in the colleges affiliated to Dr NTR UHS, Vijayawada and also for MBBS seats in Sri Padmavathi Medical College for Women (under SVIMS), Tirupati for the Academic Year 2024-25. 

On this, Dr NTRUHS has released a notification detailing the eligibility, fee structure, documents and other relevant information regarding the admission to MBBS and BDS courses.

As per the notification, candidates who are willing to take admission in undergraduate medical and dental courses must fill out the application form which is already available on the official website of NTR from 09 August 2024 at 02.00 PM to 16 August 2024 at 06.00 PM. 

Along with the registration, candidates also have to pay the registration fee, OC/BC candidates have to pay Rs. 2950/- (Rs. 2500/- + Rs. 450/- (GST @ 18%) Bank charges extra) and SC/ST candidates have to pay Rs. 23601- (Rs. 2000 + Rs. 360/- (GST @ 18%) Bank charges extra).

At the same time, if the candidates pay the registration fee after 06.00 PM on 16th August 2024, then an additional late fee will be charged from the candidates. Candidates can pay the late fee till 09.00 AM on 19th August 2024 till the display of the provisional merit list. After the addition of the late fee, the OC/BC candidates have to pay Rs. 22950/- and SC/ST candidates have to pay Rs. 22360/-. However, after the display of the Provisional Merit List, no further registrations will be allowed under any circumstances. The detailed registration with a late fee is as follows-

S.NO

CATEGORY

FEE IN RS.

LATE FEE RS.

TOTAL AMOUNT

1

OC/BC

(Rs.2500/- + Rs.450/- (GST

18 %).

(Fee Rs.16,950 + GST @ 18% = 3,050!-)

Rs. 22950/-

2

SC/ST

(Rs.2000 + Rs.360/- (GST

18 %)

(Fee Rs.16,950 + GST @ 18% = 3,050/-)

Rs. 22360/-

The eligible candidates have to submit their applications through online mode only along with uploading the scanned copies of all relevant original certificates and images of photo/signature.

Also, the same application will be considered for all the rounds of the counselling including MOP-UP round counselling and also for stray vacancies subject to fulfilment of eligibility criteria.

It is to be noted that due to technical reasons, candidates are informed that the availability of Online application will not be available from 07.00 PM on 16 August 2024 upto 09.00 PM on 18 August 2024. Hence, candidates who got registered and paid upto the above cutoff date but who could not upload the required scanned original documents can upload the same after 09.00 PM on 18 August 2024 and upto 20 August 2024 by 06.00 PM. Also, the application and Processing Fee including the Late Fee once paid will not be refunded or adjusted to a future date under any circumstances.

DOCUMENTS

Candidates also need to submit a few documents for Admission into undergraduate medical and Dental Courses for the seats available under Competent Authority Quota in the colleges affiliated to Dr NTR UHS, Vijayawada and also for MBBS seats in Sri Padmavathi Medical College for Women (under SVIMS), Tirupati for the Academic Year 2024-25. Following are the details to be submitted by the candidates-

1 NEET UG – 2024 Re-revised Rank Card.

2 Birth Certificate (SSC Marks Memo).

3 Qualifying Exam Certificate (Intermediate Marks Memo OR Equivalent — Grade Certificate not Accepted).

4 Study Certificates from 6th to 10th (If Single certificate upload the same for all years as a PDF file).

5 Study Certificates – Intermediate or equivalent for 2 Years Of Single certificate upload the same for arrears as PDF file).

6 Transfer Certificate (Intermediate / 10+2).

7 Caste Certificate.

8 Minority Certificate issued by Minority Welfare Officer (Muslim Only.

9 Income and Asset certificate for Economically Weaker Sections (EWS) valid for the year 2024-25 (Financial year 2023-24) issued by the Tahsildars concerned on or after 01.04.2024 pertaining to A.P – Non­Statewide Institutions and Tahsildars of AP & Telangana pertaining to Statewide Institutions for claiming reservation under EWS (candidates who are not covered under SC, ST & BC).

10 Parental Income Certificate/White Ration Card.

11 Person with Benchmark Disability (PwBD) Certificate.

12 NCC Certificates (If more than one certificate scan all into a single PDF file).

13 CAP Certificate (If more than one certificate scan all into a single PDF file) (If applicable)

i If retired personnel: 1. Children of Armed Forces Personnel (CAP) Certificate issued by the Zilla Sainik Welfare Officer. 2. Discharge Book (All pages). 3) Ex-Servicemen Identity Card issued by the Zilla Sainik Welfare Officer. 4) Pension Payment Order. 5) If any other priorities the proof of related documents. All certificates should be in a single PDF.

ii If Serving Personnel:

1. A Service Certificate issued by the Commanding Officer from the working Unit / Regiment duly mentioning the permanent home address declared by serving personnel at the time of enrolment in the Armed Forces.

2. If any other priorities the proof of related documents. All certificates should be in a single PDF.

14 Sports Certificate (If more than one certificate scan all into a single PDF file).

15 Police Martyr Children Certificate.

16 Anglo Indian Certificate.

17 Bharath Scouts and Guides Certificate.

18 Non-local candidates claiming 15 % of AP Unreserved seats.

19 Minimum 10 years Study Certificate of Student / either of parents, if studied in Andhra Pradesh only OR Minimum 10 years Residence Certificate (only Andhra Pradesh State) of either of parents OR Current employment Certificate of either of parents, if working in Andhra Pradesh only.

20 Aadhar Card.

21 Local status Certificate issued by MRO of AP (candidates migrated from Telangana to Andhra Pradesh.

22 Candidate’s Latest passport-size Photo.

23 Specimen Signature of the Candidate.

The application forms for Admission into undergraduate medical and Dental Courses are invited from the eligible General category (OC / EWS) candidates who have secured the 720/162 minimum cut-off score, Persons with Disability-General Category (OC/EWS) candidates who have secured the 161/144 minimum cut-off score and SC/ST/BC& Persons with Benchmark Disability of BC / SC/ ST Categories candidates who have secured the 161/127 minimum cut-off score in National Eligibility and Entrance Test- Undergraduate (NEET UG) 2024. Below are details of the minimum cutoff score obtained in NEET UG 2024

S.NO

CATEGORY

QUALIFYING CRITERIA

CUTT-OFF SCORE (OUT OF 720)

REMARKS

1

General category (OC / EWS)

50th Percentile

720/162

Candidates scoring equal to or more than this cut-off score have been declared as qualified.

2

Persons with Disability-General Category (OC/EWS)

40th Percentile

161/144

OC-PwBD candidates scoring equal to or more than this cut-off score have been declared as qualified.

3

SC/ST/BC& Persons with Benchmark Disability of BC / SC/ ST Categories.

45th Percentile

161/127

SC / ST / BC / SC-PwBD / BC-PwBD / PwBD-ST candidates scoring equal to or more than this cut-off score have been declared as qualified.

ELIGIBILITY

1 The candidate should be an Indian National or Person of Indian Origin (PIO) or Overseas Citizen of India (OCI) Card holder and should satisfy the Local or Non-local status in Andhra Pradesh. Provided that the candidates who got registered as Persons of Indian Origin (PIO) / Overseas Citizen of India (OCI) Cardholders on or after 04.03.2021 are eligible for admission only against any Non-Resident Indian seat or any supernumerary seat and will not be eligible for admission against any seat reserved exclusively for Indian Citizens.

2 The candidate should have passed Intermediate (10+2 pattern) or its equivalent examination with Physics, Chemistry, Biology (Botany, Zoology) / Biotechnology and English.

i OC candidates should obtain not less than 50% marks in Science subjects.

ii BC/SC/ST candidates should obtain not less than 40% marks in science subjects.

iii OC PwBD candidates should obtain not less than 45% marks in science subjects.

3 The candidate should complete 17 years of age as on 31-12-2024. The candidates who do not complete 17 years as on 31-12-2024 are not eligible for admission into MBBS and BDS Courses and they need not apply for the counseling.

4 The candidates who wish to claim seats under Anglo Indian, Sports & Games, CAP (Army), NCC, Persons with Disabilities (PWD), Bharath Scouts and Guides and Police Martyrs Children (PMC) also need to fulfil the eligibility criteria.

5 The candidates who claim admission under the Persons with Benchmark Disabilities (PwBD) category shall mention in the online application that they are applying under the PwD category and have to appear before the Medical Board, to be constituted by the Competent Authority and notified by the University for Eligibility under PwBD status along with a valid disability certificate issued not later than three months prior to submitting his /her application.

FEE STRUCTURE FOR MBBS COURSE

For the MBBS Course, all the government medical colleges have to pay a total of Rs. 15,000/-. Government Medical Colleges permitted from the academic year 2023-24 onwards will have to pay a total of Rs 32,15,000/-, Sri Padmavathi Medical College for Women (SVIMS), Tirupati have to pay a total of Rs 25,60,000 and Private Un-aided Minority and Non-Minority Medical Colleges will have to a total of Rs 52,96,500. Below are details of the fee structure for the MBBS Course-

S.NO

CATEGORY OF SEAT

TUITION FEE PER ANNUM

1

All Government Medical Colleges.

Competent Authority Quota incl. All India Quota: Rs. 15,000/-.

2

Government Medical Colleges are permitted from the academic year 2023-24 onwards.

General Category incl. All India Quota: Rs.15,000/- (MBBS)

Self-Financing Category: Rs.12,00,000/-

NRI Category: Rs.20,00,000/-.

3

Sri Padmavathi Medical College for Women (SVIMS), Tirupati

Competent Authority Quota incl. All India Quota: Rs.60,000/-.

NRI Category: Rs.25,00,000/-.

4

Private Un-aided Minority and Non-Minority Medical Colleges.

Category A (Competent Authority): Rs.16,5001-.

Category B (Management): Rs.13,20,000/-.

Category C (NRI): Rs.39,60.000/-.

FEE STRUCTURE FOR BDS COURSE

For the BDS Course, all government Dental colleges have to pay a total of Rs. 9,000 and Private Un-aided Minority and Non-Minority Dental Colleges will have to pay a total of Rs. 17,74,300. Below are details of the fee structure for the BDS Course-

S.NO

CATEGORY OF SEAT

TUITION FEE PER ANNUM

1

All Government Dental Colleges.

Competent Authority Quota incl. All India Quota: Rs. Rs.9,000/-

2

Private Un-aided Minority and Non-Minority Dental Colleges.

Category A (Competent Authority): Rs.14,300/.

Category B (Management): Rs.4,40,000/-/-.

Category C (NRI): Rs.13,20.000/-.

To view the notification, click the link below

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SC dismisses plea seeking NEET PG 2024 postponement

The Supreme Court dismissed the plea seeking a postponement of the National Eligibility-and-Entrance Test Postgraduate (NEET-PG) 2024 examination, scheduled to take place on August 11, 2024.
Filing the plea before the Supreme Court, the petitioners highlighted the inconvenience faced by the candidates who were allocated test cities far away from their home.
For more information, click on the link below:

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ICMR initiates National Health Research Priority Project to enhance emergency care systems

The Indian Council of Medical Research (ICMR) has initiated the National Health Research Priority Project to enhance emergency care systems, focusing on the immediate treatment of patients experiencing heart attacks or brain strokes, officials said on Wednesday.
The project will initially launch as a pilot in five locations- Puri (Odisha), Ludhiana (Punjab), Vidisha (Madhya Pradesh), Vadodara (Gujarat), and Pondicherry.
For more information, click on the link below:

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