Archive for month: July, 2024

New Delhi: A total of 4762 healthcare facilities in Tamil Nadu received the highest number of Kayakalp Awards in the Fiscal Year 2023-24 by the government, informed the Union Minister of State for Health Smt. Anupriya Patel, during a session in the Lok Sabha on Friday. 

These facilities include District Hospitals (DHs), Sub-District Hospitals (SDHs), Community Health Centers (CHCs), Primary Health Centers (PHCs), Urban Primary Health Centers (UPHCs), Urban Community Health Centers (UCHCs), Ayushman Arogya Mandirs (AAMs), and Eco-Friendly Facilities.

Among the total 4762 healthcare facilities, 35 are DHs, 176 are SDHs, 406 are CHCs, 1251 are PHCs, 320 are UPHCs, 11 are UCHCs, 2559 are AAMs, 2 are Eco-Friendly DHs and 2 are Eco-friendly SDH/CHC. 

In the data shared by MoS Health, Odisha stands out as the second highest with 3570 facilities receiving the awards and incentives from the government followed by Madhya Pradesh with 1996 facilities, Uttar Pradesh with 1873 facilities, and Bihar with 1345 facilities in the year 2023-24. 

Also read- Kayakalp Team Pays Visit To AIIMS Bhubaneswar

The Union Minister of State for Health was responding to a series of questions raised by Shri Y S Avinash Reddy, who inquired about the total number of Kayakalp awardees since the inception of the scheme, year-wise as well as the distribution of these awards across District Hospitals/Primary Health Centres/Urban Primary Health Centre Services/Urban Community Health Centres, and Health & Wellness Centres.

The Indian government introduced a National Initiative called ‘Kayakalp’ on the 15th of May 2015 as an extension of the ‘Swachh Bharat Mission’ to promote cleanliness, hygiene, and sanitation in Public Health Facilities across the country. District Hospitals, Sub-divisional hospitals, Community Health Centres, Primary Health Centres, and Health & Wellness Centres within the public healthcare system that have demonstrated exceptional standards of cleanliness, hygiene, and infection control are acknowledged and honoured with awards. Healthcare facilities that achieve a score of over or at least 70% are given the award along with a Rs 50 lakh cash reward.

Responding to these questions, MoS Health informed that “The number of healthcare facilities given incentives as per Kayakalp Scheme since its inception, year-wise”.

Number of Healthcare Facilities Selected for Kayakalp Incentives are as follows:-

Healthcare Facilities	FY 2015-16	FY 2016-17	FY 2017-18	FY 2018-19	FY 2019-20	FY 2020-21	FY 2021-22	FY 2022-23	FY 2023-24
District Hospital	97	191	289	395	372	455	410	465	465
SDHs/CHCs	0	318	760	1140	1769	2559	2154	2806	2303
Primary Health Centers	0	1044	1729	2723	4078	6330	5329	7522	7246
Urban Health Facilities	0	0	181	562	1010	1531	1216	1867	1553
Ayushman Arogya Mandir (SC)	0	0	0	0	374	1932	4758	10575	14877
Eco-Friendly Facility(DH,SDH/CHC)	0	0	0	0	0	0	48	64	66
Total	97	1553	2959	4820	7603	12807	13915	23300	26510

Further, the Minister provided an exhaustive list of the Kayakalp winner facilities for FY 2023-24, classified by state and type of facility. The Andaman and Nicobar Islands, Arunachal Pradesh, Chandigarh, Daman Diu & Dadra Nagar Haveli, Goa, Ladakh, Lakshadweep and Meghalaya received the least awards with 2, 47, 40, 78, 22, 34, 6 and 40 respectively. 

Also read- JIPMER Bags Second Prize Under Kayakalp Award Scheme

New Delhi: The Government is not considering any proposal to abolish the National Eligibility-cum-Entrance Test (NEET) exam at the national level, the Minister of State in the Union Ministry of Health and Family Welfare, Smt Anupriya Patel recently confirmed before the Lok Sabha.

MoS Patel informed this in response to the questions raised by Parliament member Shri S Venkatesan. He sought to know from the Ministry if the Government was aware of the resolution of the Tamil Nadu State Legislative Assembly dated 28 June, 2024 urging the Union Government to approve Tamil Nadu’s NEET exemption bill and to make amendments to the National Medical Commission Act in order to abolish NEET at the national level.

He also sought to know the details of the Government’s response to the resolution of the Tamil Nadu Legislative Assembly.

However, in response to these questions, the Union Minister of State for Health confirmed that there was no plans by the Government to amend NMC Act 2019 and abolish NEET exam, which is the undergraduate entrance test for admission to undergraduate medical courses including MBBS.

“No proposal is under consideration with Government to amend National Medical Commission (NMC) Act, 2019 for abolishing NEET at the national level,” the MoS Health informed.

Medical Dialogues had earlier reported that amid the row over NEET paper leak controversy, the Tamil Nadu Assembly had unanimously passed a resolution against the NEET exam, urging the union government to scrap NEET and allow state governments to undertake medical admissions based on class 12 marks, as was done before NEET’s implementation.

The resolution was introduced by Tamil Nadu Chief Minister MK Stalin amid uproar over a paper leak in the NEET-UG 2024 examination and the sudden postponement of the NEET-PG 2024 examination.

Several regional parties, including Manithaneya Makkal Katchi, Marumalarchi Dravida Munnetra Kazhagam, Tamilaga Vettri Kazhagam, and the Communist Party of India (Marxist), supported the resolution.

Earlier, Dravida Munnetra Kazhagam (DMK) MP K. Kanimozhi reiterated the demand to “exempt” Tamil Nadu from NEET, conducted by the National Testing Agency (NTA) for medical admissions across the country.

Also Read: Tamil Nadu Assembly unanimously passes resolution to scrap NEET

Italy: Findings from contemporary registry data have revealed encouraging data for interventionists hoping that a new generation of coronary balloons may improve the treatment of in-stent restenosis (ISR).

New research to be presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) (Madrid, 9-13 September) shows that a child is almost twice as likely to develop type 1 diabetes (T1D) if their father has the condition, than if their mother has the condition.

The study, the largest of its kind, suggests that exposure to T1D in the womb confers long-term protection against the condition in children with affected mothers relative to those with affected fathers.

Understanding what is responsible for this relative protection could lead to opportunities to develop new treatments to prevent type 1 diabetes.

Lead researcher Dr Lowri Allen, of the Diabetes Research Group, Cardiff University, Cardiff, UK, says: “Individuals with a family history of type 1 diabetes are 8-15 times more likely to develop the autoimmune condition-however, studies have shown the risk is higher if the affected relative is the father rather than the mother. We wanted to understand this more.

“Previous studies have suggested that maternal type 1 diabetes is associated with relative protection against type 1 diabetes in offspring during early life. We wanted to know if this relative maternal protection from type 1 diabetes is confined just to childhood. We were also interested in what might be responsible for the effect.”

To find out more, Dr Allen, Professor Richard Oram, of the Department of Clinical and Biomedical Sciences, University of Exeter Medical School, Exeter, UK, and colleagues in the UK, Sweden and US performed a meta-analysis of data from five studies (BOX, Better Diabetes Diagnosis, TrialNet Pathway to Prevention Study, Type 1 Diabetes Genetic Consortium and StartRight) that contained information about individuals with T1D and their parents.

The analysis involved 11,475 individuals with T1D who were diagnosed when they were between 0 and 88 years old. The results show they were almost twice as likely (1.8 times more likely) to have a father with T1D as a mother with the condition. This was the case for individuals who were diagnosed with T1D in childhood (≤18 years) and as adults (>18 years). Individuals with mothers with T1D were diagnosed at a similar age to those with fathers with T1D.

“Taken together, our findings suggest the relative protection associated with having a mother versus father with type 1 diabetes is a long-term effect that extends into adult life,” says Dr Allen.

The researchers also used a genetic risk score that takes into account more than 60 different genes known to be associated with T1D, to compare the inherited genetic risk of T1D in individuals with affected mothers and fathers.

Individuals with mothers with T1D had similar scores to those whose fathers had T1D, suggesting their relative protection against T1D wasn’t due to the genes they had inherited.

However, the timing of the parent’s diagnosis was important. An individual was only more likely to have a father, rather than a mother, with T1D, if the parent was diagnosed before the individual was born.

In other words, having a mother with T1D only appears to provide a child with protection against the condition (relative to having a father with T1D) if the mother has the condition during pregnancy.

“This, coupled with the finding that the inherited genetic risk of type 1 diabetes was not different in individuals with affected mothers and fathers, suggests that exposure to type 1 diabetes in the womb is critical,” says Dr Allen.

“Further research is needed to determine what it is about exposure to type 1 diabetes in the womb that is most important – is it exposure to high blood glucose levels, insulin treatment, antibodies associated with type 1 diabetes, a combination of these, or exposure to another aspect of type 1 diabetes?”

Professor Oram says: “This study, the largest to investigate the risk of type 1 diabetes in individuals with affected mothers and fathers, has enriched our understanding of the differences in parental risk, relative maternal protection from type 1 diabetes and underlying mechanisms.

“This can potentially help open up new therapeutic avenues for type 1 diabetes.”

Dr Allen adds: “Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers.

“Further research is needed but ultimately, we hope that it might be possible in the future to offer treatments at the very earliest stages of life to prevent the onset of type 1 diabetes in individuals who are at particularly high risk of the disease.

“To date, just one drug has been licensed to delay the onset of the type 1 diabetes and, whilst several studies are under way to develop other treatments that delay or prevent the condition, limited progress has been made in identifying treatments that can be offered before diabetes has even begun to develop.”

Reference:

Children are less likely to have type 1 diabetes if their mother has the condition than if their father is affected, Diabetologia, Meeting: Annual Meeting of the European Association for the Study of Diabetes (EASD).

Aquestive Therapeutics, Inc. released positive topline PK data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film.

According to topline pharmacokinetic data released by Aquestive Therapeuticsregarding an epinephrine sublingual film if approved could become the first non-invasive and orally-administered epinephrine treatment for individuals with severe allergic reactions such as anaphylaxis. 

Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the United States Food and Drug Administration (FDA).

“The self-administration data again demonstrates the versatility of Anaphylm, as a product that is easy to remember, easy to carry, and easy to use,” said Daniel Barber, President & Chief Executive Officer of Aquestive. “Our groundbreaking Anaphylm formulation indicates that rapid and substantial epinephrine absorption is achieved under a variety of administration conditions. This built-in functionality addresses potential real-world emergency scenarios, where ideal administration may not happen. In contrast to single-use medical devices, Anaphylm has unique administration properties that allow delivery of the needed levels of epinephrine to provide life-saving medication to patients.”

The single-dose, three-period, randomized crossover study design compared the PK and pharmacodynamics (PD) of Anaphylm self-administered, Anaphylm HCP administered, and Adrenalin manual intramuscular (IM) injection HCP administered. The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 36 healthy adult subjects. Graph 1 below provides a comparison of epinephrine concentration across the first 60 minutes post-administration. There was no statistical difference between the Anaphylm self-administered and HCP-administered arms of the study. The median time to maximum concentration (Tmax) was 15 minutes for both the Anaphylm self-administered and HCP-administered arms, while the median Tmax for the Adrenalin IM HCP administered arm was 50 minutes post administration.

Graph 1: Baseline-Corrected Epinephrine Concentration Across Time*:

(*Lines on the graph above represent the geometric means of baseline-corrected epinephrine concentration across study timepoints. Baseline-corrected values were calculated by subtracting from the mean of three pre-dose concentrations measured at 60-, 30- and 15-minutes prior to treatment administration.)

“Experiencing and managing a severe allergic reaction can be unsettling and chaotic for patients and caregivers,” said Matthew Greenhawt, MD, MBA, MSc, an anaphylaxis expert, and allergist at Children’s Hospital Colorado and Aquestive Scientific Advisory Board member. “An orally administered product that can be rapidly and easily administered has the potential to be a game-changer for the allergy community. Anaphylm encompasses many features important to patients and caregivers, including ease of carry, ease of administration, rapid delivery of epinephrine, and no needles.”

The Company’s remaining supportive study, the oral allergy syndrome (OAS) challenge study, is underway, and the study is expected to be completed late in the third quarter or early fourth quarter of 2024. The Company is maintaining its guidance on a full product launch of Anaphylm at the end of 2025 or in the first quarter of 2026. This is based on filing an NDA late in the fourth quarter of 2024 or early in the first quarter of 2025. The table below indicates the remaining clinical studies anticipated before the submission of the NDA.

About Anaphylaxis

Anaphylaxis is a serious systemic hypersensitivity reaction that is rapid in onset and potentially fatal. As many as 49 million people in the United States are at chronic risk for anaphylaxis. Lifetime prevalence is at least 5%, or more than 16 million people in the United States. Direct costs of anaphylaxis have been estimated at $1.2 billion per year, with direct expenditures of $294 million for epinephrine, and indirect costs of $609 million. The frequency of hospital admissions for anaphylaxis has increased 500–700% in the last 10–15 years. Of patients who previously experienced anaphylaxis, 52% had never received an epinephrine auto-injector prescription, and 60% did not have an auto-injector currently available. The most common causes of anaphylaxis are foods (such as peanuts), venom from insect stings, and medications. Epinephrine injection is the current standard of treatment intended to reverse the severe manifestation of anaphylaxis, which may include skin rash, throat swelling, respiratory difficulty, gastrointestinal distress, and loss of consciousness.

About Anaphylm™

Anaphylm™ (epinephrine) Sublingual Film has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the FDA. Anaphylm is a polymer matrix-based epinephrine prodrug candidate product. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The “Anaphylm” tradename for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.