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Rs 30,000 applicator gun complicated govt talks for ZyCov-D vaccine, six shots per patient

by Medically Speaking September 28, 2021

written by Medically Speaking

New Dehli: During ongoing pricing discussions between the Government of India and Zydus Cadila pharmaceutical company on Covid vaccine ZyCov-D, two unresolved issues have arisen.

First, ZyCov-D needs 3 doses for full efficency unlike the vaccines currently in use, and secondly, it needs to use a special vaccine application costing RS 30,000 to provide a vaccine.

ZyCov-D — the world’s first DNA vaccine — is a three-dose vaccine that will be given on day zero, day 28 and day 56. Each dose consists of two shots that are supposed to be administered on each arm, and thus, a person has to be injected with a total of six shots of this vaccine to be fully vaccinated.

This means that even if the vaccine is available for the same price as the ones currently in use, the total cost of the vaccination will be about 33 per cent higher.

The vaccine also uses a needle-free applicator or a jet injector, which pressurises liquid medication into a narrow stream that is capable of penetrating skin.

The injector has two parts — an applicator that costs Rs 90 and has to be replaced after every person, and a gun that costs Rs 30,000. The gun has to be replaced after 20,000 shots, which means that it can be used on 10,000 people since each vaccine dose consists of two shots.

According to government sources, both the central government and Zydus have to reach a middle point in the ongoing price talks.

“We are awaiting the NTAGI (National Technical Advisory Group on Immunisation) recommendation on its (ZyCov-D) use but there are two obvious issues. One is that it is a three-dose vaccine. That does not mean we will not use it but we just have to reach a middle point (in price talks with Zydus). The second is that the applicator will also be provided by Zydus. One applicator (gun) can vaccinate 10,000 people but that price will also be factored into the final figure.

The vaccine’s jet injectors are manufactured by a company called Pharmajet, but the government is not looking at procuring the devices from the manufacturer at present, clarified the source.

“For now at least the applicators will be supplied by Zydus,” he said. India has already started training vaccinators in using the device.

“The gun is imported and the applicator is manufactured in the country. Eventually the gun too will be manufactured indigenously and that will change the situation considerably,” a senior health ministry official.

According to the US Centers for Disease Control (CDC), there are many advantages of using jet injectors instead of a needle for inoculation since they “prevent needle-stick injuries to health-care providers and can overcome improper, unsterile reuse”.

ThePrint reached Zydus via phone calls and email for a response but did not receive a response till the time of publishing this report.

September 28, 2021 0 comment

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Eisai, Biogen start U.S. accelerated approval for new Alzheimer’s drug Adulhem

by Medically Speaking Team September 28, 2021

written by Medically Speaking Team

Eisai Co, a Japanese pharmaceutical, started the application process for its experimental treatment for early Alzheimer’s disease on Monday, following the same fast approval pathway that helped Eisai’s research partner Biogen Inc obtain U.S. clearance for its medication in June.

The Biogen/Eisai drug Aduhelm was the first Alzheimer’s treatment to receive FDA approval in nearly 20 years, but the FDA’s controversial use of the accelerated approval process – which allows drugs for severe conditions to be approved without strong proof of patient benefit – has drawn widespread criticism.

Aduhelm was approved by the FDA based on data that it can decrease brain plaques, a known factor to Alzheimer’s disease, rather than compelling proof that it slows the illness’s progression. Companies must conduct confirmatory trials to demonstrate that the medication performs as planned.

Eisai, which is leading the development of the Alzheimer’s medication lecanemab, is now citing data from a midstage study that shows their drug candidate eliminates brain plaques even more effectively than Aduhelm while causing less brain swelling.

As it goes through the regulatory procedure, Eisai aims to benefit from its partners’ experiences. In an interview, Ivan Cheung, president of Eisai’s worldwide neurology group, stated that the business is being as open as possible.

Eisai plans to submit its application to the FDA on a rolling basis, with the goal of finishing it in the coming months. After 18 months of therapy, 80 percent of patients had no amyloid remaining in their brains, according to results from the company’s midstage trial of 856 volunteers.

That benefit also correlated with improvements seen in some patients, Cheung said. The trial was published in Alzheimer’s Research and Therapy, a peer-reviewed journal, in April.

A key point of contention with the Aduhelm approval is the timing of the confirmatory trial, which FDA officials said could take several years. Eisai already has a confirmatory, Phase III trial fully enrolled. Cheung expects results before the end of 2022.
“We understand the urgency for the public to have validating clinical data,” Cheung said.

The FDA first awarded Aduhelm a wide indication that extended beyond the studies’ findings. Cheung stated that his business solely wants the FDA to take into account the drug’s precise trial population – those with early Alzheimer’s disease.

In July, Eli Lilly and Company said that, based on mid-stage data, it intends to pursue expedited clearance for its Alzheimer’s candidate, donanemab. Lilly has stated that it intends to seek regulatory clearance in the United States before the end of the year.

September 28, 2021 0 comment

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Covid case update: Active cases below 3 lakh mark for first time in 6 months

by Medically Speaking Team September 28, 2021

written by Medically Speaking Team

After 201 days, India had a daily new case count of less than 20,000. In the previous 24 hours, 18,795 new cases have been recorded. For the first time in six months, a gradual slowdown in the country has lowered the number of active cases below 3 lakh.

India recorded its lowest number of daily Covid-19 cases in over 200 days. India’s Covid case count on Monday was just over 19,860. The last time the country had reported a lower number of daily cases was on March 9, 202 days ago. Deaths from the virus also fell to 178, the lowest daily toll since March 22. Kerala logged 11,699 fresh infections, the fewest in nearly five weeks.

The current weekly positivity rate stood at 1.88 per cent with the figure remaining less than three per cent for 95 days. The daily positivity rate has also remained below the three per cent-mark for 29 days and it stood at 1.42 per cent at present.

As many as 26,030 people were cured from the disease during the day, while 179 patients lost their lives to the virus battle. This took the total recoveries to 3,29,58,002 at 97.81 per cent.

With the administration of 1,02,22,525 vaccine doses in the last 24 hours, India’s COVID-19 vaccination coverage crossed the landmark of 87 Cr (87,07,08,636) as per provisional reports till 7 am today. This has been achieved through 84,62,957 sessions.

September 28, 2021 0 comment

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Digital Health Mission: 5 pointers that will secure your digital health record

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

Prime Minister Narendra Modi inaugurated the Ayushman Bharat Digital Mission on Monday, which will offer individuals with a digital Health ID that would store their health information. The digital Health ID’s national deployment coincides with the National Health Authority’s (NHA) celebration of the third anniversary of the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY).

Over one lakh unique Health IDs have currently been established under the National Digital Health Mission (NDHM), which was first launched on a trial basis on August 15th across six states and Union territories.

Digital health ID: Key things you should know

-Based on the foundations laid down in the form of Jan Dhan, Aadhaar and Mobile (JAM) trinity and other digital initiatives of the government, PM-DHM will create a seamless online platform through the provision of a wide-range of data, information and infrastructure services, duly leveraging open, interoperable, standards-based digital systems while ensuring the security, confidentiality and privacy of health-related personal information.

This mission will create interoperability within the digital health ecosystem, similar to the role played by the Unified Payments Interface in revolutionising payments.

– The key components of PM-DHM include a Health ID – unique 14-digit health identification number- for every citizen that will also work as their health account. The national Health ID will be a repository of all health-related information of a person. The health ID will enable access and exchange of longitudinal health records of citizens with their consent.

-This health account will contain details of every test, every disease, the doctors visited, the medicines taken and the diagnosis. This information will be very useful as it is portable and easily accessible even if the patient shifts to new place and visits a new doctor.

-The Health ID is created by using a person’s basic details and mobile number or Aadhaar number. Personal health records can be linked and viewed with the help of a mobile application, a Healthcare Professionals Registry (HPR), and Healthcare Facilities Registries (HFR).

September 27, 2021 0 comment

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10 fruits that people with diabetes must include in their diet

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

We have repeatedly emphasised the need of a robust immune system during the last 17 months. And, especially if you are diabetic, your food and nutrition play a significant role in developing the correct sort of immunity. Eating fruits is one of the most pleasant methods to fulfil your sweet appetite while also meeting your nutritional needs. Despite several studies and research on fruit intake in diabetes, there are numerous hypotheses on the appropriate type of fruit consumption and its relationship to blood sugar levels.

Eating seasonal and locally available fruit offers several health advantages, ranging from lowering blood sugar and inflammation to combating high blood pressure – all owing to their rich vitamin and mineral content! They are high in antioxidants such as vitamins A, B, C, and E, as well as minerals such as iron, calcium, magnesium, and fibre.

Monika Manchanda, Chief Culinary Officer, and Co-Founder, LiveAltLife listed 10 fruits that are not just diabetic-friendly but are loaded with fiber and water content which can slow down the sugar spikes and sugar absorption rate.

Apples: Apples are not just nutritious and filling; According to a study, they are significantly associated with a lower risk of type 2 diabetes if consumed in moderation. Turns out there is a truth in the old saying, “An apple a day keeps the doctor away”, after all!
Avocados are a great source of healthy fats and more than 20 vitamins and minerals. They are high in fibers as well and have been linked with lowering the risk of diabetes.
Berries: Adding berries is one of the best ways to add a variety to your diabetes-friendly diet. You can choose from blackberries, blueberries, or strawberries because all of them are power-packed with antioxidants, vitamins, and fibers.
Papaya is rich in natural oxidants, which makes it a perfect pick for people with diabetes. It reduces the chances of future cell damage.
Star fruit: This sweet and sour fruit is rich in dietary fiber and vitamin C. It also positively impacts anti-inflammatory processes and can help repair cell damage, and it has minimal fruit sugars as well.
Kiwi fruit is an excellent source of Vitamin E, K, and potassium, and they are low in fruit sugars as well, which makes it a perfect diabetic-friendly fruit.
Melons (Musk melon and watermelon): Powerful hydrating fruits like cantaloupe and melons are recommended for people with diabetes, and people with the risk of developing diabetes. Eat-in moderation for multiple nutritional benefits like fiber, potassium, magnesium, vitamin B, and C.
Dragon fruit is full of dietary fibers, vital vitamins, minerals, and antioxidants.
Pears are nutrient-rich, and they are known to fight inflammation and improve digestion.? Studies also suggest that consuming pears along with a healthy diet reduces the risk of type 2 diabetes.
Orange: This citrus fruit is full of fiber that helps slow down sugar absorption into the bloodstream, and its vitamin C component helps improve immunity levels.

Add fruit to your salads to enjoy their goodness with a sprinkle of cinnamon, it tastes better and reduces sugar spikes. Add nuts like walnuts and almonds to complement your fruit snack. you can also add flaxseeds to balance the glycemic load in the body.

Input Source: IANS

September 27, 2021 0 comment

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Taking breaks may lead to breakthroughs

by Medically Speaking September 27, 2021

written by Medically Speaking

Thought it might feel like it at first, meditation isn’t actually doing anything. You might find it difficult to not fidget if you’re new to meditation.

But it’s all worth it once you pass that stage.

What is the reason for meditating? It calms the mind, relaxes the body, releases good feelings into the bloodstream and produces measurable changes in the physical brain.YourYour brain is constantly reacting to stimulation and creating new neural pathways through a process called neuroplasticity. Positive messages have positive effects. Negative messages have negative effects.

And positive ones can increase gray matter volume.

This means the way you talk to yourself is important. Messages like “This may be a lot of work, but I know I can get it done” are key. Because whether you opt for positive or negative, your brain probably believes you!

So, to defeat feelings of being overworked and overwhelmed, try this. Sit still, breathe deeply and picture something pleasant — or better yet, something you feel grateful for. When your attention strays (and it will), just keep bringing it back to your breath and whatever image you’ve chosen.

Even 5 minutes can make a big difference. But don’t be surprised if your sessions start naturally getting longer because meditation just feels good.

Best of all, you might return to the task that felt like a major challenge with a new perspective — and maybe some creative inspiration — to help you get the job done. Efficiently. Effectively.

And with a deep sense of calm.

September 27, 2021 0 comment

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Eating less fat may save your hair

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

Normally, HFSCs self-renew every hair follicle cycle. This is part of the process that allows our hair to continuously grow back. As humans age, HFSCs fail to replenish themselves leading to fewer HFSCs and therefore hair thinning. Although overweight people has higher risk of androgenic alopecia, whether obesity accelerates hair thinning, how and the molecular mechanisms have been largely unknown. The TMDU group aimed to address those qeustions and identified some of the mechanisms.

“High-fat diet feeding accelerates hair thinning by depleting HFSCs that replenish mature cells that grow hair, especially in old mice. ” says lead author of the study Hironobu Morinaga. “We compared the gene expression in HFSCs between HFD-fed mice and standard diet-fed mice and traced the fate of those HFSCs after their activation. “We found that those HFSCs in HFD-fed obesed mice change their fate into the skin surface corneocytes or sebocytes that secrete sebum upon their activation. Those mice show faster hair loss and smaller hair follicles along with depletion of HFSCs.”

“Even with HFD feeding in four consecutive days, HFSCs shows increased oxidative stress and the signs of epidermal differentiation.”

“The gene expression in HFSCs from the high-fat-fed mice indicated the activation of inflammatory cytokine signaling within HFSCs” describes Emi K. Nishimura, senior author. “The inflammatory signals in HFSCs strikingly repress Sonic hedgehog signaling that plays crucial role in hair follicle regeneration in HFSCs.

The researchers confirmed the activation of the Sonic hedgehog signaling pathway in this process can rescue the depletion of HFSCs. “This could prevent the hair loss brought on by the high-fat diet. “said Nishimura.

This study provides interesting new insights into the specific cellular fate changes and tissue dysfunction that can occur following a high-fat diet or genetically induced obesity and may open the door for future prevention and treatment of hair thinning as well as for understanding of obesity-related diseases.

Story Source: Materials provided by Tokyo Medical and Dental University.

September 27, 2021 0 comment

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Ligelizumab And Omalizumab Effective For Treating Chronic Spontaneous Urticaria, JAMA findings suggest

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

The biologic medicines ligelizumab (72 or 240 mg) and omalizumab (300 or 600 mg) can be suggested as effective therapies for chronic spontaneous urticaria (CSU) that is not controlled by H1 antihistamines. The findings were reported in the journal JAMA Dermatology. Chronic spontaneous urticaria (CSU) is a kind of autoimmune condition. Therapy is frequently challenging, although the initial approach necessitates the use of high-dose non-sedating antihistamines. No study has been able to produce a comprehensive evaluation of the advantages and risks of all known therapies for persistent spontaneous urticaria caused by H1 antihistamines.

Surapon Nochaiwong, Chiang Mai University, Chiang Mai, Thailand, and colleagues, therefore, aimed to evaluate different treatment effects of pharmacologic treatments among patients with H1 antihistamine–refractory CSU.

The researchers explored internet databases from conception until April 19, 2021 for this aim. It comprised randomised controlled studies (RCTs) that looked at the benefits and risks of pharmacologic therapies in adolescent or adult CSU patients. who had an insufficient reaction to H1 antihistamines were independently assessed for inclusion by two investigators
There were 23 randomised clinical studies with a total of 2480 individuals that evaluated 18 different treatments or doses with placebo.

The results of the study were:

The standardized mean differences for change in urticaria symptoms were −1.05 for ligelizumab, 72 mg;−1.07 for ligelizumab, 240 mg;−0.77 for omalizumab, 300 mg;and −0.59 for omalizumab, 600 mg.
No significant differences in treatment unacceptability were observed.With respect to benefits and harms, the network estimates illustrated that the most efficacious treatments were achieved with ligelizumab, 72 or 240 mg (large beneficial effect), and omalizumab, 300 or 600 mg (moderate beneficial effect).

Nochaiwong and the team concluded that “The findings in this meta-analysis suggest that the biologic agents ligelizumab, 72 or 240 mg, and omalizumab, 300 or 600 mg, can be recommended as effective treatments for patients with CSU who have had an inadequate responseto H1 antihistamines. Head-to-head trials with high methodologic quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of CSU.”

September 27, 2021 0 comment

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Better health infra, COVID-19 vaccination will help hospitality sector, says PM Modi

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

Addressing the launch event of the Ayushman Bharat Digital Mission on Monday, the Prime Minister Narendra Modi said in order to make tourists feel safe, tourism-dependent States and UTs like Himachal Pradesh, Andaman and Nicobar vaccinated the resident population at a fast pace.

Hospitals and hospitality work in tandem, said PM Modi, adding that places with more vaccination and better healthcare infrastructure will attract more tourists, especially during the COVID-19 pandemic.

“Hospitals and hospitality work in tandem. Today is also World Tourism Day, integrated health infra’s positive impact reflects on tourism, especially after COVID. More vaccination means more tourists, which is why vaccination in Himachal Pradesh, Andaman and Nicobar is at pace,” he said.

Speaking on the occasion, the Prime Minister also expressed gratitude to all doctors, nurses, the medical staff of the nation, for their efforts in the vaccination drive or treatment of COVID patients.

The Prime Minister said in order to improve healthcare services in India, it is very important that the medical services of the villages should be improved.

“Today the network related to primary health care is being strengthened in the village and near the house. So far 80,000 such centres have been made operational. Unprecedented reforms are also taking place in medical education to transform India’s health sector. Today more doctors and paramedical are being prepared in the country than before in 7-8 years,” he said

He said that along with a better medical system, it is also necessary that the poor and middle class spend the least on medicines.

Therefore, the Central government has kept essential medicines, and equipment required for surgery, and dialysis cheap. Incentives have been given to use the best generic drugs made in India for maximum use in treatment. More than 8,000 Jan Aushadhi Kendras have given great relief to the poor and middle class,” he stated.

The Prime Minister noted that Ayushman Bharat Digital Mission will now connect the digital health solutions of hospitals across the country.

He noted that Ayushman Bharat Digital Mission will play a big role in eliminating problems in the medical treatment of the poor and middle class.

September 27, 2021 0 comment

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PM Modi launches Ayushman Bharat Digital Mission via video conferencing

by Medically Speaking Team September 27, 2021

written by Medically Speaking Team

Prime Minister Narendra Modi launched the Ayushman Bharat Digital Mission through video conferencing on Monday. The pilot project of Ayushman Bharat Digital Mission was announced by the Prime Minister from the ramparts of Red Fort on August 15 last year. Currently, the programme is being implemented on a pilot basis in six Union Territories.

“Today begins a Mission that has the power to bring a revolutionary change in India’s health facilities. Three years ago, on Pandit Deendayal Upadhyaya’s birth anniversary, Ayushman Bharat Yojana was implemented. Happy that Ayushman Bharat Digital Mission is being started nationwide from today,” said PM Modi.

The Prime Minister said that in the last seven years, the campaign, which has been going on for the last seven years to strengthen the health services of the country, is entering a new phase from today.

“We have been able to take the vaccine to everyone, under the free vaccine campaign. India has been able to apply about 90 crore vaccine doses today, and Co-WIN has a big role in it,” he said

Ahead of the launch Union Health Minister Mansukh Mandaviya said, “On 15th August 2020, PM Modi had announced the mission (Ayushman Bharat Digital Mission) from the ramparts of the Red Fort. I am happy that he is launching it today. I believe that this will bring a revolutionary change in the health sector.

According to the Prime Minister’s Office (PMO), the nation-wide rollout of the Ayushman Bharat Digital Mission coincides with the National Health Authority (NHA) celebrating the third anniversary of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY).Union Health Minister Mansukh Mandaviya will be present on the occasion.

PMO said Ayushman Bharat Digital Mission will create a seamless online platform through the provision of a wide range of data, information and infrastructure services, duly leveraging open, interoperable, standards-based digital systems while ensuring security confidentiality and privacy of health-related personal information.

The Mission will enable access and exchange of longitudinal health records of citizens with their consent.

“The key components of the Mission include a health ID for every citizen that will also work as their health account, to which personal health records can be linked and viewed with the help of a mobile application; a Healthcare Professionals Registry (HPR) and HealthcareFacilities Registries (HFR) that will act as a repository of all healthcare providers across both modern and traditional systems of medicine. This will ensure ease of doing business for doctors/hospitals and healthcare service providers,” the release said.

“Ayushman Bharat Digital Mission Sandbox, created as a part of the Mission, will act as a framework for technology and product testing that will help organizations, including private players, intending to be a part of the National Digital Health Ecosystem become a Health Information Provideror Health Information User or efficiently link with building blocks of Ayushman Bharat Digital Mission,” it added.

“The Centre believes that the Mission will create interoperability within the digital health ecosystem, similar to the role played by the Unified Payments Interface in revolutionizing payments. “Citizens will only be a click away from accessing healthcare facilities,” said PMO.

September 27, 2021 0 comment

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