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The Medicines and Healthcare products Regulatory Agency (MHRA) has on Friday approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years-old and older who weigh 45kg or more. The medicine was approved via a fast-track approval process for medicines, known as the International Recognition Procedure (IRP), which allows the MHRA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The decision follows an approval for the drug by the US Food and Drug Administration (FDA). This is the first time the MHRA has approved a new medicine following FDA approval. The MHRA said it considered the assessment made by the US regulator as part of its own review, facilitating a rapid approval process. APDS is an inherited disorder where the patient is unable to fight infections because the immune system does not work properly. The main symptoms usually occur in the first two years of life and include repeated lung infections and a failure to grow and develop normally.

Professor Anthony Harnden has officially commenced his role as chair of the Medicines and Healthcare products Regulatory Agency (MHRA). During his first 100 days, Professor Harnden plans to engage extensively with MHRA staff and partner organisations to gain a strong understanding of "how to drive forward the strategic direction of the MHRA to maintain the UK as a global centre of excellence in life sciences, in the best interests of patients and the public." The new MHRA chair has highlighted three primary areas of focus: Protect patient safety through robust safety surveillance systems Embrace risk-proportionate regulation Foster an inclusive workplace where people flourish. With a 40-year career in the NHS, including 33 years as a general practitioner in Wheatley, Oxfordshire, Professor Harnden brings a wealth of experience to the role. He is a professor of primary care at the University of Oxford. Until December 2024, he was also a registrant council member of the General Medical Council and chair of the Remuneration Committee.

It has been reported that several Austrians have been taken to the hospital after injecting fake Ozempic, as confirmed by health regulator. Austria's Federal Office for Safety in Health Care (BASG) confirmed that the patients have suffered hypoglycaemia and seizures. It is believed that the injections contained insulin instead of the weight loss drug, semaglutide. The health regulator has urged doctors and patients to verify their medication stocks.

To curb the supply issue of HRT medicine, the government has taken a further action by issuing SSPs for Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets - with appropriate alternatives. The move aims to allow community pharmacists to supply specified alternatives to the prescribed HRT products without needing to seek authorisation from the clinician who has prescribed the medicine. The regulator said that the availability of Premique Low Dose has impoved 'thanks to SSPs issued on 29 April to restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months' supply'. "Since these measures were implemented, further deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. The manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking action to increase UK supply." It added, "SSPs restricting prescriptions to a maximum of three months' supply will also be issued for substitute products, as a precautionary measure to ensure the supply of those substitutes is maintained."

Your gut, often referred to as your "second brain," plays a crucial role in your overall health and well-being. From digestion to immunity, mood regulation to nutrient absorption, the gut impacts various aspects of our daily lives. With increasing awareness of the gut-brain connection, prioritizing gut health has become a cornerstone of holistic wellness. In this article, we explore effective strategies to support and nurture your gut, empowering you to enhance your quality of life through simple yet impactful practices. Nourish with Probiotic-Rich Foods The gut microbiome, comprised of trillions of bacteria, fungi, and other microorganisms, is a dynamic ecosystem essential for digestive health and immune function. To maintain a healthy balance of gut flora, incorporating probiotic-rich foods into your diet is paramount. Yogurt, kefir, kimchi, sauerkraut, and kombucha are excellent sources of beneficial bacteria that promote gut diversity and resilience. These fermented foods not only replenish your gut with probiotics but also provide essential nutrients and enzymes vital for optimal digestion. By regularly including probiotic foods in your meals, you can foster a thriving gut microbiome, fortifying your body's natural defenses against pathogens and inflammation.

Superdrug Online Doctors has made travelling easy ahead of Easter by introducing jet lag 'melatonin' tablets into its travel services portfolio to help those taking long haul flights. The company has seen an 287 per cent increase in demand for its travel services and products. Malaria treatment is up by 272 per cent, gut health products up by 317 per cent, jet lag melatonin tablets increasing by 900 per cent since launch and Period Delay services which offer more choice when it comes to the timing of periods up by 195 per cent year-on-year. Dr Sara Kayat, Superdrug's medical ambassador, comments: "Jet lag is a temporary sleep problem that affects people who travel across different time zones. It can occur when your internal clock, the function that lets your body know when to stay awake and when to sleep, is disrupted by a new time zone and puts your internal clock out of sync. Melatonin is a hormone we produce to help regulate our sleep cycles, and a synthetic version can be taken in the short term to manage jet lag."

To help manage the ongoing supply disruptions, the health regulators have extended to 28 October 2022, serious shortage protocols (SSPs) for 12 of the 13 hormone replacement therapies (HRT). "The only HRT SSP set to expire on 29 July 2022 is for SSP021 Premique low dose 0.3mg/1.5mg modified-release tablets. After 29 July, there will be no need to restrict quantities of Premique tablets as its supply situation has now stabilised," said PSNC. In addition, the dose equivalence advice and endorsement guidance for SSP024 and SSP025 have been updated. SSP024 and SSP025 have been updated by DHSC to provide greater clarity to pharmacists on the dose equivalences to determine the appropriate quantity to supply. Pharmacists are asked to refer to the latest SSP versions and endorsement guidance published on NHSBSA's website.

In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with regulatory standards. Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence to water service compliance a legal obligation and a critical aspect of operational integrity. THE LEGAL COMPLICATIONS OF POOR WATER QUALITY Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set strict criteria for the types of water used, including purified water, water for injection, and sterile water. Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. Regulatory compliance ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing

The World Health Organization (WHO) reiterated its concerns about tobacco companies' continued targeting of young people through various channels such as social media, sports, and music festivals, as well as the introduction of flavored products. In a joint report with industry watchdog STOP released on Thursday, the WHO accused these companies of attempting to ensnare a new generation in nicotine addiction. While facing stricter regulations on traditional cigarettes, major tobacco firms and newcomers have turned to alternatives like vapes, arguing they are intended for adult smokers. However, the WHO and STOP highlighted in their report that these products often appeal to youth, with their attractive designs and fruity flavors making them more appealing to children than to adults in many countries.

It's no secret that the world of work can be dangerous. Every day, workers are injured on the job, and in some cases, these injuries can be quite serious. If you're unfortunate enough to find yourself in this situation, it's important to know what steps to take to get the medical care you need. There are several ways to get proper medical aid if you're injured at work, and each option has its own set of benefits and drawbacks. HEALTH INSURANCE If your employer offers health insurance, this will likely be your first port of call when seeking medical care after a workplace injury. The main benefit of using your employer's insurance is that it will usually cover the majority of your medical expenses. However, there are some drawbacks to this option. First, your employer's insurance may only cover treatment from specific doctors or hospitals. This can make it difficult to get the care you need on time. Second, your employer's insurance may not cover all of the costs associated with your injury, leaving you with a hefty bill. Very often, workers consider obtaining private insurance, especially if they're working as ex-pats or freelancers. It is good to note that in these cases, private insurance would then be used in combination with their employer's insurance, giving them a greater degree of coverage. However, even if you're only insuring yourself, this insurance can be beneficial because you'll be able to choose your doctor, and you may have a greater range of coverage.

The NHS claims that it's been able to save taxpayers £1.2 billion in just three years by procuring hundreds of hospital medicines at a better price. The adoption of cheaper versions of a single drug - adalimumab - which is used to treat more than 45,000 patients with rheumatoid arthritis, inflammatory bowel disease and psoriasis, has accounted for about one third of the savings. After the exclusive patent on the drug - originally known as its brand name Humira - expired in 2018, the NHS struck cost-saving deals to bulk-buy generic versions, which have the same quality, safety and efficacy of a branded one. Since then, tens of millions of pounds have been saved by buying cheaper generic versions of other medicines for conditions ranging from severe skin infections to aggressive blood cancers. Four in five medicines prescribed in the NHS are now non-branded, helping the NHS to achieve significant savings while ensuring the continuity of high-quality patient care. NHS chief executive Amanda Pritchard said: "Smart deals by the NHS mean patients are getting the best medicines and taxpayers are getting best value.

The Pharmacist' Defence Association (PDA) has welcomed the General Pharmaceutical Council (GPhC) and the Pharmaceutical Society of Northern Ireland (PSNI)'s plan to ensure a more robust, fair and positive experience for trainees, provisionally registered and potential pharmacists who will be sitting the November 2022 assessment. "Many candidates at the latest (June 2022) assessment experienced significant delays, technical issues, inadequate invigilation, and disturbances in test centres around the UK as the newly appointed company BTL ran the high-stakes pharmacist examinations for the first time. The next online exam is due in November 2022 and the PDA welcome proposed improvements to be introduced before that sitting," said the association. For some, provisional registration was the accepted response from the GPhC, but for others, such as potential pharmacists who did not want the provisional role, those unable to find a suitable provisional post, or some that did not meet the criteria for provisional registration, they found themselves in financial difficulties through no fault of their own, having reasonably expected to have joined the register in the Summer.

The Pharmacist's Defence Association (PDA) has raised concerns over the adoption of Digital Clinical Excellence (DiCE) guidelines for online prescribing of GLP-1 receptor agonists for weight management in adults. This follows a clash with expert recommendations commissioned by the General Pharmaceutical Council (GPhC) as the PDA "believes the final guidance conflicts with the expert opinion underpins the GPhC's prosecution strategy towards pharmacist prescribers under investigation." In a recent statement, the PDA highlighted the discrepancy between DiCE's guidance and the expert report employed by the GPhC to prosecute pharmacist prescribers using a questionnaire-based consultation model. This conflict has prompted the PDA to withhold its endorsement of the DiCE guidance as it differs from an expert report commissioned by the GPhC. The PDA's reservations stem from the inherent risks associated with questionnaire-based prescribing.

Two Indian pharmaceutical companies, Cipla and Glenmark, are pulling back certain products from the American market due to manufacturing concerns, according to the US Food and Drug Administration (USFDA). A New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution due to "short fill", news agency PTI reported, quoting the latest Enforcement Report issued by the US health regulator. Produced at the company's Indore SEZ plant, this medication is used to manage symptoms associated with lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA decided to recall the affected lot following complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, the USFDA said, adding that the drug maker initiated the Class II recall in the US market on March 26 this year.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Anthony Harnden, a professor of primary care at the University of Oxford, as its new Chair. Professor Harnden brings decades of experience to the role. He has served the NHS for 40 years, including 33 years as a general practitioner in Wheatley, Oxfordshire. Until the end of December 2024, he will also continue as a registrant council member of the General Medical Council and chair of the Remuneration Committee. He previously served as deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI), where he played a key role in ensuring public trust and patient safety during the distribution of the COVID-19 vaccine. Professor Harnden succeeds Stephen Lightfoot, who served as MHRA chair from September 2020 until stepping down in 2023. On his appointment, Professor Harnden said: "It is a great honour and privilege to be appointed by ministers to be the next MHRA chair. I am looking forward to making a contribution to the future successes of the organisation.