Group items tagged

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

Two new medications which fight drug-resistant superbugs could soon become available to NHS patients in England after the National Institute for Health and Care Excellence (NICE) said they offered value for money. NICE said Cefiderocol and ceftazidime-avibactam will be the first antimicrobial drugs to be made available as part of a subscription-style payment model that incentivises research and development of antimicrobials by testing new approaches to evaluating and paying for them. As part of part of a project with the NHS and the Department of Health and Social Care, the new payment model is designed to address the growing threat posed by antimicrobial resistance - a serious global problem - which develops when the pathogens that cause infection evolve to make antibiotics and other antimicrobial drugs less effective or stop them from working altogether.

One of the long-standing medical mysteries is the diagnosis of diabetes in majority of patients suffering from high blood pressure. The reason for this had been unknown. But now, an international team of universities have made a breakthrough. The research, published online in 'Circulation Research', involved contributions from collaborating scientists in Brazil, Germany, Lithuania, and Serbia, as well as the UK and New Zealand. The important new discovery has shown that a small protein cell glucagon-like peptide-1 (GLP-1) couples the body's control of blood sugar and blood pressure. Professor Julian Paton, a senior author, and director of Manaaki Manawa, The Centre for Heart Research at the University of Auckland, said: "We've known for a long time that hypertension and diabetes are inextricably linked and have finally discovered the reason, which will now inform new treatment strategies." GLP-1 is released from the wall of the gut after eating and acts to stimulate insulin from the pancreas to control blood sugar levels. This was known but what has now been unearthed is that GLP-1 also stimulates a small sensory organ called the carotid body located in the neck.

Any prescription for Promethazine hydrochloride 10mg tablets x 56 submitted for payment to the NHSBSA for July 2022 will be reimbursed at the new price of £17.77 not as per the price concession of £13.45 announced in the 4th concessions update published on 29 July 2022, said the Pharmaceutical Services Negotiating Committee (PSNC). In July 2022, PSNC received several reports from contractors unable to obtain Promethazine hydrochloride 10mg tablets (56) at the published Drug Tariff price of £4.24. Therefore, it submitted a request for a price concession, which was granted and subsequently published but this was later withdrawn after confirmation from the Department of Health and Social Care (DHSC) that due to the price change mechanism, the reimbursement price for Promethazine hydrochloride 10mg tablets has increased from £4.24 to £17.77 for July 2022. PSNC said, "Following the price change mechanism rules, for generic drugs (excluding drugs in Category M), a price change up to and including the 8th of the month takes effect for prescriptions dispensed in that same month. Any price change after the 8th takes place in the following month."

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot be hoarded or exported from the UK market. The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs. In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to patients across the UK. The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.

The 'Life and Health Sciences Launchpad' has been introduced to focus on the precision medicine sector. It would help businesses and researchers to level up their impact on economic growth within the region. The launchpad has been funded by Innovate UK, part of UK Research and Innovation (UKRI). Kerry Curran, Director of GB & EU Trade in the Department for the Economy hailed the decision to support NI's "trailblazing" sector. She said: "Life and Health Science, including our highly innovative precision medicine cluster, is an area the Department is also prioritising through its 10X Economy Vision, and this Launchpad represents a further endorsement of the world-leading growth potential of precision medicine, and indeed life and health science, in Northern Ireland.

Hospitals and healthcare providers across the UK have been notified about the shortage of an anti-inflammatory medicine caused by a manufacturing failure. The Department of Health and Social Care (DHSC) on Friday (3 May) issued a National Patient Safety Alert stating that Erelzi 50mg solution for injection in pre-filled pen will be out of stock from early May until mid-July 2024. "The supply issues have been caused by a manufacturing failure resulting in delays in production and the implementation of global allocations," it said. However, it noted that homecare providers (Alcura, Healthnet and Sciensus) have sufficient stock to supply existing patients until mid/late May 2024. Although Erelzi 50mg pre-filled syringes (PFS) are still available, they cannot support a full increase in demand, the DHSC warned.

The UK government has decided to ban disposable vapes to tackle the rise in youth vaping and protect children's health, Prime Minister Rishi Sunak announced on Sunday (28 January 2024) during a visit to a school. Official figures revealed that the number of children using vapes has tripled in the past three years, with nine per cent of 11 - to 15-year-olds now affected by this rising trend. Disposable vapes are believed to be mainly driving the worrisome rise in youth vaping, with the number of 11- to 17-year-old vapers using disposables estimated to have increased by almost ninefold in the last two years. Sunak said: "As any parent or teacher knows, one of the most worrying trends at the moment is the rise in vaping among children, and so we must act before it becomes endemic. "The long-term impacts of vaping are unknown and the nicotine within them can be highly addictive, so while vaping can be a useful tool to help smokers quit, marketing vapes to children is not acceptable."

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."

The Association of the British Pharmaceutical Industry (ABPI) has welcomed the National Institute for Health and Care Excellence's leadership in introducing a new approach to the evaluation of antibiotics. On Tuesday (12 April), NICE published a draft guidance to tackle antimicrobial resistance under which two new antimicrobial drugs - cefiderocol and ceftazidime-avibactam - became the first to be made available as part of the UK's innovative subscription-style payment model. Commenting on the announcement of the new draft guidance, Richard Torbett, chief executive of the ABPI, said: "This is an important milestone in the UK's global leadership on AMR. Antibiotics underpin modern medicine, but the increasing threat of antibiotic resistance remains one of the biggest global health challenges we face. "To tackle this, it is critical that the appropriate frameworks are in place for companies to invest the billions of pounds required to discover the new antibiotics needed for patients.

The National Institute for Health and Care Excellence (NICE) has rejected the use of olaparib on the NHS for treatment of adults with hormone-relapsed prostate cancer with BRCA1 or BRCA2 mutations which has spread to other parts of the body. In a draft guidance issued today (January 5) NICE said evidence around the drug made by AstraZeneca was uncertain and approving it would not be a good use of NHS funds. Current treatment for metastatic prostate cancer that no longer responds to hormone therapy is chemotherapy with docetaxel, cabazitaxel, or radium 223 dichloride - a treatment option for people with symptomatic bone metastases who have already had docetaxel or cannot have it. NICE said: "Clinical trial evidence showed that people taking olaparib have more time before their disease gets worse, and live longer overall, than people having retreatment with abiraterone or enzalutamide. However, retreatment with abiraterone or enzalutamide is not considered effective and is not standard care in the NHS.

The Competition and Markets Authority(CMA) has disqualified a former director of the pharmaceutical wholesaler Lexon for allegedly breaking competition law. Pritesh Sonpal - who has been accused of illegally sharing commercially sensitive information with competitors - will not be allowed to take up any director role or be involved in the management of any company based in England, Scotland or Wales for four years. The CMA in March 2020 found that Lexon - along with the pharmaceutical companies King Pharmaceuticals and Alissa Healthcare Research - illegally shared commercially sensitive information about the antidepressant nortriptyline, used by thousands of NHS patients, to inflate the price. Lexon was fined £1.2 million for breaking competition law. The government watchdog said between 2015 and 2017, when the cost of the drug was falling, the three companies exchanged information about prices, the volumes they were supplying and Alissa's plans to enter the market, in order to reduce competition.

Dr Nik Kotecha OBE, chairman of Morningside Pharmaceuticals and the Randal Charitable Foundation, has won the Distinguished Alumni Award at Imperial College London's Alumni Awards 2022. The annual awards honour outstanding alumni who have demonstrated sustained excellence in their personal and professional achievements and have made a substantial impact on society. Dr Kotecha, who founded Morningside in 1991, which manufactures and supplies generic and branded medicines to the UK and globally, said: "I'm thrilled to be honoured by the university in this way. "As a child growing up in Leicester my family had very little, but I was fortunate to be given opportunities to gain a good education. After finishing my degree in Newcastle; Professor Steve Ley FRS at Imperial College took a chance in accepting me into his eminent group and this really was the opportunity I needed to forge a career.

Rosalind Brewer, the CEO of Walgreens Boots Alliance, Inc. (WBA), the parent company of Boots UK, has resigned from her position after serving for less than three years. The prominent US pharmaceutical company is currently in the process of searching for her successor. Ginger Graham, the lead independent director, has been appointed as the interim CEO. "WBA's board of directors and Brewer have mutually agreed on her departure as chief executive and board member," the company said in a statement. Brewer officially stepped down from her roles as chief executive and director on Thursday (Aug. 31). She assumed the CEO role in March 2021, succeeding Executive Chairman Stefano Pessina. Prior to this, Brewer held the position of CEO at Starbucks. The leadership change aligns with WBA's shift towards becoming a broader healthcare company, a strategic move initiated by Brewer and her team in October 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

Rising chronic illnesses and an aging population are threatening to bankrupt the National Health Service, Labour's Shadow Health Secretary Wes Streeting has said on October 11. Streeting announced a substantial £1.1 billion injection to strengthen the NHS with the goal of clearing the backlog and introducing additional clinics on evenings and weekends. The frontbencher outlined a reform agenda to ensure NHS is back on its head for the future of healthcare in the UK. Streeting said that a Labour government will not waste "money we don't have"- instead aims to revolutionise the NHS by shifting its focus from hospitals to communities. "Our emphasis is on transitioning from an analogue to a digital framework and prioritising prevention over sickness-oriented healthcare," he noted.

The Department of Health and Social Care (DHSC) and NHS England last month issued a "safety critical" national patient safety alert, warning about the UK-wide shortage of a life-saving drug used to treat patients with chronic breathing issues. NHS trusts, health authorities, ambulance services, GP practices, private healthcare providers, and community pharmacy contractors were informed that salbutamol 2.5mg and 5mg nebuliser liquid unit dose vials are in short supply, with the latter likely to remain "out of stock" until mid-April 2024. As per the alert, the shortage of the drug resulted from a combination of manufacturing issues, leading to heightened demand for alternative suppliers. It was mentioned that while terbutaline, salbutamol with ipratropium, and ipratropium nebuliser liquids remained available, they could't meet the increased demand.

Veoza, a non-hormonal treatment for menopause, has been made available on the high street for the first time in the UK. British pharmacy chain Superdrug on Thursday (1st February) announced the launch of the newly approved menopause medication, expanding its comprehensive portfolio of products and services to support menopausal women. Veoza is a prescription medication that is used to manage vasomotor symptoms, specifically hot flushes and night sweats, which affect up to 80 per cent of women during menopause, as estimated by experts. It is recommended for women who prefer not to or are unable to take hormone replacement. Perimenopausal, menopausal and postmenopausal women, aged 45-65 who are not on Hormone Replacement Therapy (HRT) or hormonal contraception, and are suffering from moderate to severe vasomotor symptoms, are eligible to take the medication, the retailer said in a release.

The Department of Health and Social Care (DHSC) published a notification regarding the shortage of Guanfacine 2mg and 3mg modified-release tablets has raised concerns within the healthcare community. This critical medicine supply notification, issued on March 28th, projects the unavailability of these tablets until the week commencing May 6, 2024. Guanfacine tablets, commonly prescribed to alleviate symptoms of hyperactivity and impulsivity while enhancing attention and concentration, play a vital role in managing conditions like attention deficit hyperactivity disorder (ADHD). However, the scarcity of these specific strengths poses challenges for patients reliant on this medication. Last year, several countries across the globe experienced shortages of medications for the treatment of attention deficit hyperactivity disorder (ADHD)including the UK, the US and Australia. Community Pharmacy England (CPE) has cautioned that while alternative strengths of Guanfacine remain accessible, they may not adequately meet the heightened demand, potentially resulting in treatment interruptions for patients.