FDA одобрило лекарство на 2 миллиона долларов, самое дорогое в истории Эта фотография, предоставленная Novartis, показывает Zolgensma. Единовременная генная терапия, разработанная Novartis, Zolgensma, обойдется в 2 миллиона долларов. Онo лечит редкое состояние, называемое мышечной атрофией позвоночника, или SMA, которое поражает около 400 детей, рожденных в США каждый год. Терапия, проводимая в течение одного часа, была одобрена для детей в возрасте до 2 лет и будет доступна в течение двух недель. (Новартис через AP)
Регуляторы США одобрили самое дорогое лекарство, когда-либо существовавшее, для редкого расстройства, которое разрушает мышечный контроль ребенка и убивает почти всех с наиболее распространенным типом заболевания в течение пары лет.
Стоимость лечения составляет 2 миллиона долларов. Фактические расходы пациентов будут варьироваться в зависимости от страхового покрытия.
Лекарство, продаваемое швейцарским производителем лекарств Novartis, является генной терапией, которая лечит наследственное состояние, называемое спинальной мышечной атрофией. Лечение направлено на дефектный ген, который настолько резко ослабляет мышцы ребенка, что он становится неспособным двигаться и, в конечном итоге, не может глотать или дышать. Он поражает около 400 детей, рожденных в США каждый год.
В пятницу Управление по санитарному надзору за качеством пищевых продуктов и медикаментов одобрило лечение под названием Zolgensma для всех детей в возрасте до 2 лет, у которых подтверждено генетическим тестом наличие любого из четырех типов заболевания. Терапия - одноразовая инфузия, которая занимает около часа.
Novartis заявила, что позволит страховщикам производить выплаты в течение пяти лет, по 425 000 долларов в год, и даст частичные скидки, если лечение не работает.
Еще одним лекарством от этой болезни, одобренным в США, является препарат под названием Спинраза. Вместо одноразового лечения оно должно проводиться каждые четыре месяца. Biogen, производитель Spinraza, назначает цену по прейскуранту в размере 750 000 долларов в первый год, а затем 350 000 долларов в год после этого.
Независимая некоммерческая группа «Институт клинического и экономического анализа», которая оценивает стоимость дорогих новых лекарств, подсчитала, что цена новой генной терапии оправдана при затратах от 1,2 до 2,1 млн. Долл. США, поскольку она «кардинально преобразует жизнь семей, подвергшихся воздействию. этой разрушительной болезнью. "
Президент ICER, доктор Стивен Д. Пирсон, назвал цену лечения «положительным результатом для пациентов и всей системы здравоохранения».
Дефектный ген, вызывающий мышечную атрофию позвоночника, не дает организму вырабатывать достаточное количество белка, который позволяет нервам, контролирующим движение, работать нормально. Нервы отмирают без белка.
В наиболее распространенном типе, который также является наиболее тяжелым, по крайней мере 90% пациентов умирают к 2 годам, и все еще живые нуждаются в вентиляторе, чтобы дышать. Дети с менее тяжелыми типами становятся инвалидами медленнее и могут жить до пары десятилетий.
Zolgensma работает, предоставляя здоровую копию дефектного гена, которая позволяет нервным клеткам затем производить необходимый белок. Это останавливает разрушение нервных клеток и позволяет ребенку развиваться более нормально.
При обследовании пациентов дети с наиболее тяжелой формой заболевания, получившие золгенсму в течение 6 месяцев после рождения, имели ограниченные проблемы с мышцами. Те, кто получил лечение раньше, сделали лучше всего.
Младенцы, получавшие Zolgensma через шесть месяцев, перестали терять контроль над мышцами, но лекарство не может полностью изменить нанесенный ущерб
Еще слишком рано знать, как долго длится польза от лечения, но надежды врачей растут, что они могут длиться всю жизнь, по словам доктора Джерри Менделла, невролога из Nationwide Children's в Колумбусе, штат Огайо, который возглавлял одну из ранние исследования пациента.
«Это начинает выглядеть так», - сказал он, потому что у нескольких детей, которым сейчас 4 или 5 лет, симптомы отсутствуют.
Ранняя диагностика имеет решающее значение, поэтому Novartis работает со штатами, чтобы получить генетическое тестирование новорожденных, необходимое при рождении. Ожидается, что большинство государств будут иметь это требование к следующему году.
FDA сказал, что побочные эффекты включали рвоту и потенциальное повреждение печени, поэтому пациенты должны находиться под наблюдением в течение первых нескольких месяцев после лечения.
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Deputy Minister of Villages, Disadvantaged Areas and Transmigration Budi Arie Setiadi starting Saturday (24/10) visited a number of tourist village destinations managed by Village-Owned Enterprises (BUMDes) in East Java Province.
The tourist village visited is Mbencireng Valley in Kebontunggul Village, Mojokerto Regency, then visits to Jombang Regency include Bale Tani tourist attractions in Banjaragung Village, Pandansili bath tour in Ngampungan Village and a tour of the village nuances of Segunung Traditional Village in Carangwulung Village.
During this visit, Deputy Minister Budi Arie held discussions and dialogues with village heads, village activists and a number of village residents related to tourist destinations in the village which are one of the increasing economies of rural communities that have declined due to the Covid 19 pandemic.
The Vice Minister also appreciated the youth in the village who helped promote the village with various creative innovations from the youth in the village.
"Many village youths help in the management of BUMDes. They have helped improve the economy with various innovations from BUMDes. One of them is a tourism village managed by BUMDes, ”said Deputy Minister Budi Arie after visiting a number of tourist villages in Mojokerto and Jombang.
BUMDes, said Deputy Minister Budi Arie, could be a benchmark for village progress. If a village does not have BUMDes, it means that the potential for economic movement is not there.
"So let's work together to push the BUMDes forward. Because BUMDes operates in all fields, tourism can be culinary. Because bumdes is the motor that drives the village economy, "he said.
Furthermore, Deputy Minister Budi Arie considered that the villages in Mojokerto and Jombang had potential that could continue to be developed. Moreover, the natural and cultural wealth that continues to be preserved so that it becomes a force in providing attraction to natural and cultural tourism.
"The progress of the village lies in the seriousness of the villagers themselves to advance their village, because as long as the villagers wish to progress, I am sure that the village will definitely progress with optimism, enthusiasm, cooperation and mutual cooperation of the villagers," he said.
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In the event that you need an eating routine intend to get thinner quick, at that point you are in the correct spot. Starting a broad exercise procedure is obviously a vital piece of achieving your sound lifestyle targets, nonetheless, it is vital to remember that practicing can simply get you as of recently.
At least as fundamental is a sound eating routine arrangement, and a solid eating regimen plan doesn't just suggest taking out on Friday night takeaway gorges.
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Another crucial piece of a solid eating regimen plan when endeavoring to lessen weight is to guarantee your food has a lot of fiber. This will keep you feeling total, alongside offering your body with a lot of significant supplements and enemies of oxidants.
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It merits remembering, by the by, that as this eating regimen technique is made to help you to shed fat and drop weight, gaining bulk will be intense.
A beginner lifter with practically zero preparing experience may likely build some size, nonetheless, that is inferable from changes in the primary nerve framework.
Luckily is, in any case, the degree of protein found in this dietary strategy should be sufficient to save your current bulk.
When hoping to improve productivity and protect the muscle you have really got, you need to in like manner consider your preparation times. At the point when you take in the main part of your carb, it is ideal to work out around the occasions.
Sugars supply your body with muscle glycogen and ensuring these glycogen levels are beaten up proposes that your body won't exploit muscle tissue to support the exercise.
Having your sugars around your preparation shows that your muscles will be prepared and sufficiently able to manage whatever weight you throw at them, paying little heed to your bigger weight reduction objective.
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Monday
Breakfast:
45g oats with 300ml skimmed milk and 1tsp nectar; 200ml squeezed apple.
Treat:
120g low-fat yogurt with blueberries and nectar.
Lunch:
Barbecued chicken (1 chicken bosom) plate of mixed greens sandwich with wholemeal bread.
1 low-fat yogurt with blueberries and a small bunch of oats and nectar.
Lunch:
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Treat:
100g low-fat home cheddar and pineapple.
Dinner:
Fish niçoise plate of mixed greens (100g fish, mixed plate of mixed greens leaves, plum tomatoes, red pepper, and 4 fresh out of the plastic new potatoes).
The sharp looked at among you will have seen this technique simply covers you for multi week. You may copy the technique multiple times over, in any case, that would get a bit of exhausting. We suggest you mix it up anyway keep in the significant things you really thoroughly enjoyed devouring and change those you didn't.
Obviously, you want to keep the carbohydrate levels for every day around exactly the same anyway don't pressure about making it explicit. Just assurance you make trades for equivalent food sources. Change it out for fish.
This is anything but an exact science, it's nearly adjusting your schedules so you don't get crisps, chocolate, or any handled food sources when you're starving. What's more, perhaps most strikingly, forestalling sugar however much as could be expected.
We can't stress over this sufficient. You may follow this procedure precisely notwithstanding on the off chance that you have a jar of the carbonated drink each day notwithstanding it, you'll basically be messing yourself up.
You have really been forewarned!
Having expressed that, keeping a sound weight doesn't suggest you can never under any circumstance treat yourself. When you have really clung to a severe plan for about a month present one cheat day seven days, regardless of whether that is Saturday when you're hungover and longing scrap, or Wednesday since that is night out.
In the event that you contribute 6 days devouring admirably (or maybe essentially 5 on certain weeks) getting yourself pizza, chips, and all the things you have really killed isn't an issue. We 'd actually prompt staying a long way from sweet refreshments however.
Lean Snacks for Grumbling Stomachs.
While you become acclimated to this technique you'll probably find desires starts to get the absolute best of you. Try not to remain away, rather, get into these solid treats that will keep you fulfilled without fixing your weight reduction endeavors.
Apple cuts with nut spread:
Cut up an apple and devour it with 2 tablespoons of nut margarine almond, nut, cashew or pecan are generally extraordinary anyway pick low sugar, whole other options. Smooth or stout relies upon you.
Biltong:
This South African scope of hamburger jerky packs in the protein–you explore 30g per 100g serving–is basically zero-carb and need not taste like cardboard on the off chance that you find a magnificent butcher. By and by, choose the most un-sweet ranges.
Crudites and hummus:
Dunk new, fresh celery, carrots, peppers, or sugar snap beans into this sound chickpea-based plunge. Select your hummus cautiously notwithstanding, analyze the name to guarantee it's not stacked with salt.
Greek yogurt:
It has a lot of solid minerals comprising of potassium, phosphorous, and calcium, stacked with live germs to improve food assimilation and has multiple times the protein of routine yogurt, so it helps your satiety levels.
Guacamole:
Forestall the store variety to guarantee it's without any fixings and make your own. Crush a large portion of an avocado and incorporate a spurt of lime, a spot of coriander, and a little cut tomato.
5 Nutritional Tips to Assist Burn Fat.
Devour water and extraordinary arrangements of it.
Water is essential inconclusively all components of actual wellness and sustenance and it's sudden to numerous people how pivotal it stays in consuming fat. H20 is the medium where most cell
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