US FDA extends review of KalVista's swelling disorder drug due to heavy workload
June 13 (Reuters) - The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' (KALV.O), opens new tab drug for a type of hereditary swelling disorder due to heavy workload and limited resources, the company said on Friday.
The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said.
The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator.
The extension is the latest instance of the FDA missing a deadline following mass layoffs under a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.
The regulator also missed the target date for GSK's Nucala to treat smoker's lung.
KalVista said the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat.
The company also said it has addressed all prior information requests in a timely manner and believes the only remaining item under FDA review is the finalization of the packaging insert.
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The Sun
an hour ago
- The Sun
The 5 most common types of insomnia and the best ways to treat each – plus experts answer your burning sleep questions
WE all need good quality sleep, ideally seven to nine hours a night. Without it, we put ourselves at increased risk of cardiovascular disease, anxiety, obesity and diabetes - not to mention being short-tempered and bleary-eyed. 6 Worryingly, however, one in three of us suffers from insomnia, which can mean struggling to fall asleep, stay asleep or get restful sleep. Dr Kat Lederle, a sleep and circadian rhythm specialist at The London General Practice, tells Sun Health: 'The definition of chronic insomnia is three or more nights of poor sleep per week for three months, and daytime impairment. 'This can make you feel tired and irritable during the day, and you may have difficulty concentrating. 'Often, poor sleep is triggered by a stressful period or event. 'However, if poor sleep continues after the event and has been replaced by the worry about not sleeping, then it might be helpful to seek help.' But what intervention or treatment you need depends on what type of insomnia you have. Here are five of the most common, and expert-approved tips to combat each one for good… 1. Menopausal insomnia ABOUT half (40 to 60 per cent) of menopausal women complain about disturbed sleep, according to research published in the journal Sleep Medicine Clinics. 'Fluctuating levels of hormones can be the cause,' says Dr Lederle. 'These hormones send signals to many places, including to areas involved in the regulation of sleep in the brain. Doctor reveals the dangerous effects going to sleep after midnight has on our brain 'When these areas get confusing or mixed messages, they don't quite know what to do: whether to push for sleep or wakefulness.' Menopausal hot flushes, as well as stress or anxiety, can also lead to disturbed sleep. 'A healthy diet, topped up by supplements if your body needs them, and exercise so your physical health is looked after, is important,' says Dr Lederle. When it comes to supplements, Dr Elise Dallas, women's health GP at The London General Practice, recommends taking magnesium glycinate, 'which absorbs well and has calming properties to help relax the muscles and nervous system'. Tuck into magnesium-rich foods too, such as leafy greens, nuts and seeds, whole grains, legumes including beans, lentils and chickpeas and oily fish, such as salmon and mackerel. The best and worst foods to eat before bed By Katrina Turrill, Health News Editor IS your diet keeping you up at night? There are lots of things that can influence how well we sleep - screen time usage, caffeine and alcohol, relationship stress and bedroom temperature. You may be aware eating too soon before bed may also disrupt sleep, causing things like indigestion and acid reflux. But certain vitamins and minerals could help you have a better night's sleep, according to research. For example, a 2012 study found magnesium could help improve sleep issues in people with insomnia. While there is no conclusive evidence pointing to a diet that improves sleep, it's clear there are some foods worth eating as a late-snack over others. Benjamin Bunting, sports nutritionist, military physical training instructor and founder of beForm Nutrition, reveals the best sleep-friendly snacks... Bananas Cheese, yoghurt and milk Porridge Cherries Wholemeal bread However, there are some foods you want to stay well clear of before bedtime, said Benjamin, as they can cause blood sugar spikes and digestion issues that impact sleep. 'Calcium may also help,' Dr Dallas adds. 'It supports melatonin production, which regulates sleep-wake cycles, and is essential for muscle relaxation. 'Women over 50 should aim for 1,200mg of calcium per day, preferably from food such as dairy products, leafy greens like kale and bok choy, fortified foods, small oily fish with bones, and calcium-set tofu. 'If you're taking a calcium supplement, combine it with vitamin K2 and vitamin D to prevent calcification in the cardiovascular system.' Research in the journal Frontiers has also linked a lack of vitamin D with poor sleep. The UK Department of Health recommends a daily supplement during the winter months, when sunlight - our main source of vitamin D - is scarce. Adults and children over the age of one need 10mcg (or 400IU) a day. 6 2. Sleep-maintenance insomnia IF you're waking up once or several times during the night and struggling to get back to sleep, then you might have sleep-maintenance insomnia. 'Often it's stress-related, but it could also be a sign of a health condition such as diabetes, kidney disease, chronic pain or urinary problems, to name a few,' Dr Lederle says. 'Alternatively, it could be down to too much fluid intake during the evening, or blood sugar imbalances.' Some medications can cause insomnia as a side effect, particularly when you first start them or adjust your dose Dr Elise DallasGP Dr Dallas adds that sugary or refined-carbohydrates - such as white rice, pasta, pastries and fizzy drinks - close to bedtime can cause rapid spikes in blood sugar. This then leads to a swift insulin release followed by drops in blood sugar levels. 'This drop triggers stress hormones such as cortisol and adrenaline, which can disrupt sleep by inducing anxiety or alertness,' she says. 'Low blood sugar can also cause fatigue, weakness and sweating, making you wake up during the night.' Try to leave a couple of hours between your last mouthful and going to bed. Keep sugary foods to a minimum too and focus on slow-release carbohydrates with dinner, such as wholemeal grains. 6 3. Sleep-onset insomnia IF you're struggling to fall asleep, it might be down to a racing mind triggered by stress. 'That morphs into worry about not sleeping and its consequences on the next day,' says Dr Lederle. To help your body and mind relax and fall asleep, giving yourself downtime is a must. 'Allow the mind enough time to process the day, learn to notice the thoughts that hook you at night and then step back from them without trying to get rid of them,' Dr Lederle says. 'In many cases, this 'getting rid' can make you feel even more helpless and anxious.' You could try journaling before bed, to get your thoughts out on paper. Avoid screens at least one hour before hitting the hay too, and make sure your room is cool and your bed is comfortable. 4. Short-term insomnia HAVING sleep difficulties for less than three months is classed as short-term insomnia. 'This is usually caused by external stress or a lifestyle change, such as a new job, divorce or loss of a loved one,' says Joshua Piper, sleep clinician at Resmed UK. 'For the most part, once the blunt impact of the stress leaves, so does the insomnia.' It's important to try to maintain your usual schedule in spite of your stress. 'It's the things we start to implement when we are struggling to sleep that have a longer-term implication, such as turning to alcohol, changing our bed/wake times, Googling 'sleep cures' at 2am, and so on,' adds Joshua. 'We call these perpetuating factors, and they become the problem, not the original trigger.' 6 5. Terminal insomnia IT sounds scary, but terminal insomnia refers to waking up hours before your alarm and struggling to get back to sleep. Older age and mental health difficulties, such as anxiety and depression, can cause this, says Joshua, but it can also be a byproduct of spring and summer. It's now significantly lighter in the morning, which can have a huge impact on our body clocks. 'A simple sleep mask to block out the light can be a really easy and cheap solution,' says Joshua. But even with a mask and blackout blinds, you may still have issues with early waking. This could be caused by your medication. 'Antidepressants can cause insomnia as a side effect, particularly when you first start them or adjust your dose,' Dr Dallas says. 'Stimulants such as amphetamines (used for ADHD) can also increase alertness and energy, making it hard to fall asleep, while corticosteroids can cause increased energy and mood changes, leading to difficulty sleeping. 'Beta-blockers may cause sleep disturbances, including nightmares, decongestants can stimulate the nervous system, affecting sleep, and even antihistamines can lead to disrupted sleep patterns.' 'A discussion with the prescribing doctor is needed,' adds Dr Lederle. 5 SLEEP QUESTIONS, ANSWERED 1. Can I die from no sleep? Yes, but it's not an overnight thing. 'It's the chronic deprivation that slowly chips away at your health, increasing the risk of things like cardiovascular disease, diabetes, cancer and let's not forget, depression,' says Joshua. 'Without some quite extreme measures, your brain will always prioritise getting sleep, so the main thing here is not to worry. 'A poor night, or even multiple nights, isn't going to be your demise.' 2. What's the minimum amount of sleep I can get away with each night? GETTING little sleep is nothing to brag about. We need at least seven hours of sleep each night to stay healthy, and consistently getting less than five hours can have huge impacts on your health. 'Stop treating sleep as something passive that you 'have to do' and encourage it as something you 'want to do',' says Joshua. 'Most people need seven to nine hours of sleep (with people either side of that boundary) and almost everyone thinks they are the person that needs far less. 'The chances are though, you need more.' 6 3. Can I nap during the day to make up for lost sleep? NAPPING is a brilliant way to claw back some sleep you might have missed in the night, Joshua says. But you shouldn't nap if it affects your ability to fall asleep later that evening. 'When we nap, we chip away at our sleep pressure, typically building up over the daytime to encourage sleep later,' he adds. 'It's like blowing air into a balloon; you keep adding pressure until it eventually pops. 'But, if you release some of that pressure halfway through, it's not going to pop when you want it to later.' However, if you fall asleep at the right time, with no problem, then napping is a useful tool. 4. Why am I so tired but can't sleep? TIRED but wired? You might be sleepy all day then lie down and suddenly be wide awake. 'Tired is when you are drained mentally and/or physically. Sleepy is when you can barely keep your eyes open,' says Joshua. 'Being tired but wired is likely down to stress, poor routine and the brain learning some bad habits. 'The good news is there's an effective option called cognitive behavioural therapy for insomnia (CBTi). 'It helps break the mental loop and regain control over bedtime again.' CBTi is available on the NHS and privately. Speak to your GP or visit to find a therapist. 6 5. Why do I overthink everything at night? BEDTIME might be the first quiet moment you've had all day. 'That's when people think things over,' says Joshua. 'It's not ideal because the bedroom is for sleep, not thinking. 'It goes one step further, though; your brain doesn't power down all at once. 'The prefrontal cortex (your rational, calming voice) winds down before the amygdala (your emotional alarm system). 'For a short window, your worry centre is still active while your logic centre has gone offline so you lie there replaying old arguments or stressing about tomorrow. 'Your emotional brain's still firing, and the brakes are off.' Try creating a calming bedtime routine, with relaxation techniques like meditation or deep breathing. A simple YouTube search brings up hundreds of options, so find one that works for you. The best sleep routine and environment Thomas Høegh Reisenhus, TEMPUR® sleep specialist & sleep counsellor, reveals the key components of a good bedtime routine and environment... A sure-fire way to facilitate a better night's sleep is to practice good sleep hygiene. Establish a sleep routine that works for you and stick to it. This will help your body establish a consistent, natural sleep-wake cycle which can do wonders for your overall sleep quality. As such, try to avoid making up for lost sleep with a lie-in. Instead of sleeping in, spend your morning reading a book in bed or having a leisurely coffee in the kitchen. Ensure that your bedroom, bedding, and sleepwear are fit for purpose too. The ideal sleep environment is dark, quiet, and cool – much like a cave. If you find unwelcome sources of light are keeping you up, consider investing in an eye mask or black-out curtains. Adding soft furnishings can be a great way to reduce noise, with the surfaces having an absorptive quality, but if this doesn't work, consider embracing a soothing soundtrack to block it out. In terms of temperature, try to keep your bedroom at 18°C. You can further reduce the risk of waking up due to overheating by ensuring that all your bedding and sleepwear is made with natural, breathable materials such as cotton and linen. Bear in mind that everyone is different; what might work for most, may not work for you! Whilst knowing how much sleep you should get, how to overcome common barriers, and practicing good sleep hygiene can facilitate a great night's sleep, if you continue to struggle with sleep or fatigue persistently, do not hesitate to visit a doctor or health professional for support.
Daily Mail
2 hours ago
- Daily Mail
What's you REAL hearing age? Take this 30-second test to see
Life is full of loud noises - from rock concerts to crying babies and noisy football stadiums - so it's not surprising that our ears get weaker the older we get. But just how much should you be able to tune into at your age? Here, you can take a quick, 30-second test to find out. One of the most common types of hearing loss - presbycusis - happens as, while growing up, a person will gradually find it difficult to hear 'high-frequency' sounds, such as the voices of women and young children. According Decibel Hearing Services, this can happen for a number of reasons, including exposure to loudness, genetics and health issues. 'Many things affect our hearing as we age,' the National Institute on Deafness and Other Communication Disorders also explained. 'For example, changes in the inner ear that can affect hearing are common. Age-related changes in the middle ear and complex changes along the nerve pathways from the ear to the brain can also affect hearing.' Humans can typically hear frequencies between 20 Hz - 20,000 Hz. But these upper limits start to dwindle with age, so the average adult is much more likely to be between 15,000–17,000 Hz. Most people will comfortable be able to hear 8,000 Hz. However, those who are aged over 50 may struggle with hearing above 12,000 Hz, while people over 40 will struggle with more than 15,000 Hz. When it gets to around 17,000 Hz - only teenagers can typically hear these frequencies. Eargym have devised a test to see what your 'hearing age' is - starting at low frequencies well into the 200s Hz and going up to 200,000 Hz. At 70, many will be able to hear around 9,000 Hz, with the limit going up to about 10,000 for those in their 60s. At 50, 12,000 Hz is the upper limit, while at 40, it becomes 14,000 Hz. At 30, people will hear into 15,000 Hz, while at 20 it's about 17,000 Hz. Once you get into the teens, people may hear well up until 20,000 Hz. At 50, 12,000 Hz is the upper limit, while at 40, it becomes 14,000 Hz. At 30, people will hear into 15,000 Hz, while at 20 it's about 17,000 Hz One of the most common types of hearing loss - presbycusis - happens as, while growing up, a person will gradually find it difficult to hear 'high-frequency' sounds, such as the voices of women and young children Speaking to MailOnline last year, Andy Shanks, hearing health expert and co-founder at eargym, said: 'The majority of us will experience some form of hearing loss in our lifetimes. 'But if we can spot the signs early and make some small changes, we can take steps to protect our hearing and prevent future avoidable hearing loss.' He suggests using games such as this 30 second test to check your hearing regularly and pick up on any abnormal changes. 'Safe listening practices, such as the use of ear defenders, gigplugs and noise-cancelling headphones, can also make a big difference when it comes to protecting our hearing health long in the future,' he added. 'Hearing loss is one of the biggest modifiable risk factors for dementia and is strongly associated with poor mental health and cognitive decline. 'So taking care of our hearing at all ages is essential to protect not only our ears but also our minds.' Around 12million people in the UK are affected by hearing loss. It is associated with social isolation and cognitive decline, and is one of the biggest modifiable risk factors when it comes to developing dementia. Speaking to MailOnline last year , Andy Shanks, hearing health expert and co-founder at eargym, said: 'The majority of us will experience some form of hearing loss in our lifetimes' WHAT ARE THE SIGNS OF HEARING LOSS? Hearing loss is common, particularly when you get older. Hearing loss can affect a child's speech development and also their progress at school. It can be caused by something that can be easily treated or something more serious, so it is important to visit your GP. Common signs of hearing loss include: Difficulty hearing other people clearly and misunderstanding what they say, especially in noisy places Asking people to repeat themselves Listening to music or watching TV with the volume higher than other people need Difficulty hearing on the phone Finding it hard to keep up with a conversation Feeling tired or stressed from having to concentrate while listening Source: NHS Yet adults wait an average 8.9 years before seeking help. Research suggests hearing loss costs the UK economy £25bn a year in lost productivity and unemployment. Common signs you're suffering from hearing loss include asking people to repeat themselves, difficulty hearing on the phone and listening to music or the TV at a higher volume than other people need, the NHS warns. There are lots of possible causes of hearing loss, such as an ear infection, ear wax or age. But it could also be caused by a perforated eardrum, which causes a sudden hearing loss or Ménière's disease which can affect your balance and hearing. If you notice signs of hearing loss it is important not to self diagnose and visit your GP for a more thorough hearing test. It comes as in December, an American pharmacist has revealed 11 of the common medications that can trigger the uncomfortable sensation known as tinnitus. The condition, which affects more than 50 million people in the US, is a symptom of several medical conditions like ear injuries, earwax blockage or age-related hearing loss. Sometimes the noise is present in one or both ears and it is most commonly described as a ringing, but it can also present itself as a range of sounds including buzzing, roaring, and whistling. While there is no cure, pharmacist Ayesha Gulzar says there are things you can do to reduce its impact, starting with checking what medications you are taking. She explained: 'Certain medications cause tinnitus, which can be temporary or rarely permanent and depends on different factors. 'Common ototoxic drugs (drugs that can have toxic effects on the ears) include antibiotics, analgesics (pain relievers), blood pressure medications, anticonvulsants (anti-seizure drugs), and others.'
BBC News
2 hours ago
- BBC News
Ten foods wey dey rich in fibre
Wit di rise of very high processed foods and active lifestyles, di amount of fibre wey we dey take don drop well-well, as health problems like cardiovascular disease, obesity and some kain cancers don increase. Here we go look why fibre dey so important, wetin be di different types, and which food be di best to eat more to increase more of am. Den discover healthy, fibre-rich and ideas wey no cost, 20 different types of beans, our complete diet program and six reasons to eat more beans and legumes. Why fibre dey so important? ? Dietary fibre na di non-digestible part of plant foods wey dey pass through di digestive system relatively intact. E dey pass through di stomach and intestine nearly without any change, and den become part of di shit. Fibre-rich foods dey support digestive health by promoting regular intestinal transit and preventing constipation. But fibre dey do even more dan dat! E dey also help control blood sugar level, promote heart health and make you dey fuller for longer time, wey fit contribute to weight management. E get two main types of fibre: soluble fibre and insoluble fibre. Soluble fiber dey dissolve for water to form gelatinous substance wey dey move small small through di digestive tract. Dem fit help prevent constipation, lower blood cholesterol levels, and balance glucose levels. Foods wey dey rich in soluble fibre na oats, legumes, apples, and citrus fruits. Insoluble fibre no dey dissolve for water and e dey make our poo-poo dey thicker, and dis dey promote regular bowel movements and prevent constipation. Insoluble fibre na important fuel for our gut bacteria. Dem dey for whole grains, nuts, and many vegetables. Both types of foods dey important, and any balanced diet suppose include di two types of foods. Wetin be di quantity of fibre per day? Di recommended quantity of fibre for adults na 30 grams of fibre per day, but more dan 90% of adults for UK, for example, no dey meet dis target, according to di kontri National Food and Nutrition Survey (NDNS). Di average na about 15 to 18 grams per day, dis na half of di recommended amount. By adding fibre for your diet, you go fit easily increase your intake and enjoy di many benefits wey dey come wit am. Ten foods rich in fibre 1. Lentils Lentils na real concentrate of fibre. One cup of cooked lentils contain about 15 grams of fibre, and dis one make dem excellent source of both soluble and insoluble fiber. Dem also dey high in protein, iron, and folate, making dem wonderful choice for vegetarians and vegans. Add dem to soups, stews or salads to fill up on fibre. 2. Oats Oats dey particularly high in soluble fibre, including beta-glucan, wey don show say e fit to lower cholesterol levels and improve heart health. One cup of oats dey contain about 4 grams of fibre. Grab one bowl of hot porridge for breakfast, try cold oatmeal overnight, or blend oatmeal inside smoothies to add fibre. 3. Chia seeds Chia seeds dey tiny but mighty. Just two tablespoons contain about 10 grams of fibre, most of am dey soluble. Dem also contain omega-3 fatty acids, protein, and various micronutrients. Add chia seeds to yogurt, smoothies, or make chia pudding for a high-fibre snack. 4. Black beans Black beans na also excellent legume wey dey rich in fibre. One cup of cooked black beans dey provide about 15 grams of fibre. Dem dey rich in protein and iron, and di soluble fibre wey dem contain dey contribute to blood sugar regulation and heart health. Use them for burritos, chilies, or mix am for salads. 5. Apples Apples na convenient and delicious source of fibre. One medium apple dey contain about 4 grams of fibre, including good amount of soluble fibre in form of pectin, wey fit help lower cholesterol levels. Eat dem raw, cut dem to pieces inside your salads, or bake dem for oven come sprinkle cinnamon on top for healthy treat. 6. Broccoli Broccoli na one of di most fibre-rich vegetables, wit one cup wey contain about five grams. E also contain antioxidants, vitamins C and K, as well as oda health-promoting nutrients. Steam or roast broccoli as side dish or add am inside your stir-fries and cooked dishes. 7. Pears Pear na sweet and juicy fruit wey dey naturally rich in fibre. One medium pear contains about five grams of fibre, mostly for im skin. Dem also contain good amount of soluble fibre, wey dey help digestion and blood sugar control. Eat dem fresh, poached, or sliced with cheese or nuts for healthy snack. 8. Avacado Avocado no be only just great source of healthy fats, but e also dey high in fiber. One avocado contain about 10 grams, mixture of soluble and insoluble fibre. E also contains potassium and antioxidants wey dey promote heart health. Grind into wetin Oyibo dey call guacamole, spread am on toasted bread or slice am into salads and wraps. 9. Nuts Tree nuts na fantastic source of insoluble fibre. Almonds contain about 14 grams per cup, and pistachios and hazelnuts dem also dey high in fibre. Nuts dey packed wit vitamins, minerals, and healthy fats. Including dis delicious bites regularly for your food and snacks fit to promote heart health, help manage weight and improve overall well-being. Add almond butter to your smoothies, use nuts for your baked goods, like flapjacks, and add ground almonds to your curries for creamy, nourishing sauce. 10. Sweet potatoes Sweet potatoes no be only great source of vitamins A and C, but dem dey also provide about 4 grams of fibre per medium potato (wit di skin on). Dem contain both soluble and insoluble fibre, making dem high-fibre food. Roast, mash or fry dem for healthier alternative to traditional potatoes. Overall, which food dey high in fibre? E no dey complicated to add fibre to your diet. By choosing whole, minimally processed foods and planning your food to include fibre-rich foods, you fit to significantly increase di amount of fibre wey you dey take. Prioritise variety – include fruits, vegetables, legumes, seeds, and whole grains to make sure say you get both soluble and insoluble fibre. Few final tips: Fibre na one of di most underrated nutrients, still e get far-reaching effects on health — from digestion and heart health to blood sugar levels and weight management. By adding dis 10 fibre-rich foods to your diet, you go dey do your body great favour.
