Latest news with #MedicinesandHealthcareproductsRegulatoryAgency
Yahoo
a day ago
- Business
- Yahoo
ImmunityBio's (IBRX) ANKTIVA Gets Approved by UK's Medicines and Healthcare Regulatory Agency
ImmunityBio, Inc. (NASDAQ:IBRX) is one of the . On July 8, ImmunityBio, Inc. (NASDAQ:IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency has approved ANKTIVA with Bacillus Calmette-Guérin for treating certain bladder cancer patients. This is significant as it marks the first approval for the company outside of the United States of America. Moreover, the drug is a first-in-class IL-15 agonist, which works by activating and multiplying immune cells, specifically NK cells and T cells that help the body fight cancer. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. In addition, clinical studies have shown strong results as some patients maintained a complete response for over 47 months at the last review. ImmunityBio, Inc. (NASDAQ:IBRX) is a biopharmaceutical company that develops therapies and vaccines that boost the immune system to fight cancer and infectious diseases. While we acknowledge the potential of IBRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Newsweek
5 days ago
- Health
- Newsweek
Ozempic Could Change Births in America
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. More babies could be born because of Ozempic as it can improve fertility and has led to surprise pregnancies, experts have told Newsweek. There have been multiple reports of an "Ozempic babies" phenomenon after women reported becoming pregnant on the drug, even while on birth control in some cases. Last month, the United Kingdom's Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health and Social Care, urged women on Ozempic and other similar weight loss drugs to make sure they are on effective birth control if they do not want to conceive. Professor Alexander Miras, a clinical professor of medicine who has led studies on how weight loss interventions influence live birth rates in women with polycystic ovary syndrome (PCOS), told Newsweek that this is happening because women with obesity often have no periods and do not routinely use contraception. Photo-illustration by Newsweek/GettyCanva "Medications for obesity cause significant weight loss and this can rapidly improve fertility, thus the unwanted pregnancies," he said. Similarly, reproductive endocrinologist Dr. Patricia Jimenez, from WashU Medicine, told Newsweek: "For people with irregular menstrual cycles, weight loss has been shown to increase ovulation and therefore pregnancy." "Weight loss also can improve semen parameters," she added. However, Jimenez stressed that these drugs "are not fertility medications, and for people struggling with infertility, the best option is to talk with a specialist about fertility treatment." Meanwhile Karin Hammarberg, a senior research fellow at Monash University who has authored several pieces on "Ozempic babies," said that unwanted pregnancies from weight loss drugs could be a cause for concern. "They will cause some unexpected and unplanned pregnancies, which is concerning since we don't know how this drug might affect the growing fetus," she told Newsweek. While a lot is still unknown about Ozempic, its ability to affect fertility may have an impact on the number of births in America, which is, along with most other countries, struggling with declining birth rates. Could Ozempic Lead to an Increase in Birth Rates? "We may indeed observe an increase in birth rates because a previously untreated population of women with infertility will now have more access to effective pharmacotherapy for obesity that can rapidly improve their fertility," Miras said. While Hammarberg agrees that weight loss drugs could add a number of births to the total, she does not believe it "will make any difference to birth rates at a population level." Jimenez said "we need more data to understand whether these medications will have a significant impact on birth rates" as "there is no evidence that weight loss increases live birth rates in people with regular ovulatory cycles or with fertility treatments." America's fertility rates are projected to average 1.6 births per woman over the next three decades, according to the Congressional Budget Office's latest forecast released this year. This number is well below the replacement level of 2.1 births per woman required to maintain a stable population without immigration. With financial struggles and worries often cited as reasons for people having fewer children, solutions often focus on calling for policies that include making child care, health care, housing and education more accessible. Others have focused on cultural impacts. For example, Norway is a global leader in parental leave and child care policies, but is still facing a birth rate crisis. Its Birth Rate Committee has pointed largely to cultural changes, including the fact that fewer people are having their first child before the age of 30 because lower rates of couples in their 20s are staying together. Dr. Jonathan Sher, founding partner of Scotland's Coalition for Healthier Pregnancies, Better Lives and the former deputy director of the Queen's Nursing Institute Scotland, is one of several who have urged countries to look at fertility and pregnancies as a way of tackling birth rates. He previously wrote that remedies linked to finances are "built on the assumption that people of childbearing potential are increasingly choosing not to become parents." Sher said that focusing on achieving healthier fertility and pregnancies could save multiple "unhappy endings" which includes miscarriages, stillbirths, therapeutic terminations, very premature deliveries, harm to the mother's health and/or her future reproductive life, as well as babies born with life-limiting birth defects. "These are pregnancies intended to be full term and produce healthy babies who will grow up to become net assets to their economies and societies," Sher said. Although saving all of these pregnancies would be impossible, "many of these unwelcome outcomes could, and should, have been prevented through robust, universal, effective policies and practices under the umbrella of preconception and interconception health, education and care," he said. How Does Ozempic Work? Ozempic is an injectable prescription drug that was developed to manage blood sugar levels in patients with Type 2 diabetes. It has surged in popularity because of how it assists weight loss. It is based on a naturally occurring human hormone called glucagon-like peptide 1 (GLP-1), which plays an important role in regulating appetite and blood sugar levels. Its active ingredient is a molecule called semaglutide, which mimics the structure of this GLP-1 hormone and activates its receptors. In doing so, semaglutide induces feelings of fullness while delaying the emptying of the stomach, making users feel less hungry and therefore less likely to overeat. Jamie Winn, of the online pharmacy Universal Drugstore, previously told Newsweek that "Ozempic may interfere with the absorption of oral contraceptives, which can reduce their effectiveness and lead to an unwanted pregnancy." "If you are taking Ozempic and an oral contraceptive, it is recommended that you also use a barrier method of birth control such as a condom," Winn added. "Another option is to switch to a long-acting reversible contraceptive such as an IUD." But, like Jimenez, Winn said: "While Ozempic may increase fertility, caution should be taken if you get pregnant while on this medication. There is not enough information on the use of Ozempic by pregnant women, and there were adverse outcomes in animal studies. Pregnant rats that were given Ozempic had an increased rate of fetal death and birth defects. "Because it can take up to six weeks for Ozempic to be cleared from your body, it is recommended that you stop Ozempic at least two months before you plan on getting pregnant," Winn said. "If you become pregnant or think you are pregnant while on Ozempic, stop taking the medication and call your health care provider immediately."
The Irish Sun
17-07-2025
- Health
- The Irish Sun
I lost 8st in a YEAR on Mounjaro – I had to have an organ removed but I still went back on the jabs as soon as I could
A WOMAN has revealed how shedding a whopping 8st completely transformed her life but also landed her in a major surgery. The weight loss warrior, Em, has been documenting her transformation on her TikTok, 2 A woman lost 8st in a year on Mounjaro Credit: TikTok/ @emsjourney 2 She had to have major surgery but still went back on the jabs Credit: TikTok/ @emsjourney Despite the drama that followed, Em is still a massive fan of Mounjaro and says it's completely changed her life. Within months of starting, the weight was dropping off, her periods came back, and her PCOS, something she'd battled for years, finally started to settle down. But just as things were looking up, her journey took a painful turn. Only two months in, she was hit with a searing pain under her ribs that had her doubled over and rushing to A&E. Read more on fat jabs Doctors ran tests and found a Her kidneys were struggling, inflammation was through the roof, and surgery quickly became the only option. By October, doctors told her she'd need her And while that sounds scary enough on its own, she was also midway through a course of GLP-1 medication. Most read in Fabulous But her consultant gave her the green light to stay on She said: 'Because I was still such a high weight, it made more sense to stay on it and make myself safer for surgery.' I lost 6st with fat jabs but ended up with 'Ozempic face' – I got youthful look back with six make-up tricks Post-op, she was back on the meds just two weeks later and didn't look back. She's since reached a peak dose of 15mg, and now she's tapering down, currently on 10mg. The results are impressive. Em has lost a jaw-dropping 8st in just 12 months. Her While the gallstone drama was a shock, she says Experts say there's a very real link between GLP-1 weight-loss drugs like Mounjaro and gallbladder problems, especially gallstones and inflammation of the gallbladder. In fact, so many patients report it that the UK's Medicines and Healthcare products Regulatory Agency lists gallbladder issues as a known side effect of drugs like Mounjaro. Rapid weight loss, especially more than 1.5kg (3.3lbs) a week, increases your risk of developing gallstones. That's because your liver pumps out Combine that with the fact that GLP-1s slow down digestion, including how often the gallbladder empties, and you've got a recipe for trouble. So while these meds can deliver dramatic results, they're not without risks. Doctors often recommend regular scans or blood tests, and say anyone experiencing sharp pain in the upper right side of their tummy, nausea, or fever should get checked out urgently. Still, Em has no regrets. She says the gallbladder scare was a small price to pay for getting her life back. Fat jabs hitting shelves soon The so-called 'fat jab' revolution is officially under way and it could change the way Brits tackle weight loss for good. For the first time ever, family doctors across England are now dishing out the powerful new weight-loss injection Mounjaro, as part of a major NHS shake-up to fight obesity. The drug, which contains the active ingredient tirzepatide, is being dubbed the strongest slimming jab yet and more than three million people could be eligible to get it on prescription. It's a landmark move in the war on waistlines, with obesity levels in England more than doubling since the 90s. Until now, similar injections like Ozempic and Wegovy were mainly reserved for type 2 diabetics or available through pricey private clinics. But from now on, GPs will be encouraged to prescribe them to those at greatest risk — a move health bosses hope will slash sick days, boost the economy, and help cut rates of cancer, heart disease and dementia. Not everyone qualifies, though. Only those with the highest health risks are likely to get the green light. Everything you need to know about fat jabs Weight loss jabs are all the rage as studies and patient stories reveal they help people shed flab at almost unbelievable rates, as well as appearing to reduce the risk of serious diseases. Wegovy – a modified version of type 2 diabetes drug Ozempic – and Mounjaro are the leading weight loss injections used in the UK. Wegovy, real name semaglutide, has been used on the NHS for years while Mounjaro (tirzepatide) is a newer and more powerful addition to the market. Mounjaro accounts for most private prescriptions for weight loss and is set to join Wegovy as an NHS staple this year. How do they work? The jabs work by suppressing your appetite, making you eat less so your body burns fat for energy instead and you lose weight. They do this my mimicking a hormone called GLP-1, which signals to the brain when the stomach is full, so the drugs are officially called GLP-1 receptor agonists. They slow down digestion and increase insulin production, lowering blood sugar, which is why they were first developed to treat type 2 diabetes in which patients' sugar levels are too high. Can I get them? NHS prescriptions of weight loss drugs, mainly Wegovy and an older version called Saxenda (chemical name liraglutide), are controlled through specialist weight loss clinics. Typically a patient will have to have a body mass index (BMI) of 30 or higher, classifying them as medically obese, and also have a weight-related health condition such as high blood pressure. GPs generally do not prescribe the drugs for weight loss. Private prescribers offer the jabs, most commonly Mounjaro, to anyone who is obese (BMI of 30+) or overweight (BMI 25-30) with a weight-related health risk. Private pharmacies have been rapped for handing them out too easily and video calls or face-to-face appointments are now mandatory to check a patient is being truthful about their size and health. Are there any risks? Yes – side effects are common but most are relatively mild. Around half of people taking the drug experience gut issues, including sickness, bloating, acid reflux, constipation and diarrhoea. Dr Sarah Jarvis, GP and clinical consultant at said: 'One of the more uncommon side effects is severe acute pancreatitis, which is extremely painful and happens to one in 500 people.' Other uncommon side effects include altered taste, kidney problems, allergic reactions, gallbladder problems and hypoglycemia. Evidence has so far been inconclusive about whether the injections are damaging to patients' mental health. Figures obtained by The Sun show that, up to January 2025, 85 patient deaths in the UK were suspected to be linked to the medicines. Top priority will go to patients with a body mass index (BMI) of 40 or more or 37.5 for people from certain ethnic backgrounds and who have at least four obesity-linked health conditions. That includes things like high blood pressure, cholesterol, prediabetes, type 2 diabetes, sleep apnoea and heart disease. Doctors are also expected to check whether patients have first tried to lose weight through diet and exercise before offering the jab. Despite the huge hype, not all GPs will be able to hand them out and even if you qualify, you might be told to wait or referred to a specialist clinic instead. Experts are warning that while the jabs can be a game-changer, they're not a magic fix. Side effects can range from mild nausea to more serious complications, and not everyone will tolerate them well. And with demand through the roof, many Brits are turning to the private route. Of course, always remember that too-good-to-be-true prices, quick-check applications and zero aftercare are all major warning signs. Experts say if you are thinking about going private, do your homework and don't gamble with your health for a quick fix.
Daily Mirror
16-07-2025
- Health
- Daily Mirror
Size of illegal cosmetic surgery trade unknown, health regulator admits
Andy Morling, a director of criminal enforcement at the Medicines and Healthcare products Regulatory Agency, said they 'don't have a baseline to understand how big this trade is' The official health regulator has admitted it does not know how big the criminal cosmetic surgery trade is. Andy Morling, a director of criminal enforcement at the Medicines and Healthcare products Regulatory Agency (MHRA), told MPs they 'don't have a baseline to understand how big this trade is'. He admitted this means officials are unable to know whether the illegal trade is 'growing or reducing'. Mr Morling said around 2,000 illegally traded botox doses had been seized over the last two years - which suggests the trade is 'relatively small' compared to the 17.5 million doses of illegally traded medicine seized last year. But he admitted to the Commons' women and equalities committee: "We don't have a baseline to understand how big this trade is. Any crime is difficult to measure to any degree of certainty because it's a hidden thing. Crime is naturally not done in plain sight most of the time.' Talking about his suggestion that the trade is 'relatively small', he added: 'Our intelligence, and we work on intelligence, gathering it from multiple different sources, to come to these conclusions. 'So whilst I haven't put a size on it, and I wouldn't be able to put a size on it, and I also wouldn't be able to put a size on whether it's growing or reducing, I'm afraid, because without a baseline, that would be meaningless, what I am saying is, for us based on our current intelligence picture, it is not as significant as some other areas of the illegal trade in medicines. That doesn't mean to say we're not giving it attention because we are.' It came as Sarah Owen, Labour MP and committee chairwoman, grilled health and safety directors at the Department for Health and Social Care, the NHS and the MHRA. She questioned how practitioners were not being sent to prison for causing horrific damage through botched cosmetic procedures - pointing out that if they did that sort of harm with a 'baseball bat' there would be no question of it. She told them: 'There is a huge sector now worth billions of pounds to the UK economy that has non-surgical procedures, and we heard about the horrors of liquid Brazilian Butt Lifts. And how Sasha, who came to give evidence, ended up with sepsis and in a coma and given a 5% chance of living. And thankfully, she was able to come and give us evidence. The Mirror's three cosmetic demands 1. Cosmetic operations such as liposuction, surgical face lifts and surgical eye lifts, should only be carried out by properly trained surgeons on the GMC specialist register. These surgeons should have UK Board Certification in Cosmetic Surgery for their area of practice. 2. All operations and high risk procedures must be surgically safe and carried out in clinics and hospitals inspected by the Care Quality Commission (CQC). 3. Make it a legal requirement for beauty clinics who offer non-surgical interventions to have malpractice insurance. 'Why is it that in the UK, you can buy filler, anybody, any of us, could buy filler and inject it into our faces, whereas in many other countries it would be illegal to do so. 'And why is it on the criminal enforcement side of it that that person that did that to Sasha, that money, that damage to her, is still able to practice on her high street in her local town, whereas if she had done that damage with to Sasha with a baseball bat, she'd actually be in prison. Why is it that any of us could buy filler and botox in this country?' Dr Alison Cave, chief safety officer at the MHRA, said they were 'actively looking' at a range of products, which don't currently have a medical claim. Mr Morling said: 'Criminals need to be treated like criminals.' But he also said behaviour needed to be scrutinised, adding: 'I firmly believe there are a number of practitioners out there who just don't know what they're doing is illegal, so their behaviour can be changed. So it's about changing the behaviour of the offender, but also changing the behaviour of the customer.' In a victory for the Mirror 's cosmetic surgery campaign, Health Secretary Wes Streeting said ministers will set out new cosmetic surgery regulations to deal with misconduct in the UK over the next week.
The Star
14-07-2025
- Business
- The Star
UK agrees to deal with Vietnam to remove pharmaceutical trade barriers
Vietnam will hasten the registration of new medicines and vaccines, while recognising approvals from more regulators. - Reuters LONDON: Britain said it would strike an agreement with Vietnam to make it easier for pharmaceutical firms to sell UK-made medicines in the nation, under a new trade strategy that emphasises quick, industry-specific deals. Britain launched the new strategy last month, promising a nimbler approach compared to the emphasis it placed on full-fledged free trade agreements following its departure from the European Union. Vietnam will hasten the registration of new medicines and vaccines, while recognising approvals from more regulators, including Britain's Medicines and Healthcare products Regulatory Agency, the British government told Reuters in a statement. The deal is expected to be confirmed later on Monday. "The removal of pharmaceutical barriers with one of our closest trading partners in Asia is a boost for the UK pharmaceutical industry and proof our Industrial and Trade Strategies are already delivering," British trade minister Douglas Alexander said. The deal could be worth 250 million pounds (US$337 million) to the British pharmaceutical sector over the next five years, the government added. The UK-Vietnamese Joint Economic and Trade Committee will meet in London on Monday (July 14) and also discuss financial services and renewable energy. Britain has taken a tougher line on some other sectors, however, with steel imports from Vietnam set to be restricted under a new quota regime. Life sciences, including pharmaceuticals, are a priority sector under Britain's new industrial strategy, which was also launched last month. However, that plan has been delayed by a dispute over drug pricing with the British pharmaceutical sector, which says the government needs to value medicines more fairly and adjust the payments they make back to the health service. - Reuters
