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The NHS on Thursday (May 5) said it has rolled out the arthritis drug baricitinib for seriously ill Covid patients. The Recovery trial, conducted by the NHS and University of Oxford, found that 13 per cent fewer severely ill patients died of Covid when treated with the drug compared to existing treatment options. Typically used to treat arthritis to reduce pain and inflammation, baricitinib can now be given to hospitalised Covid patients in addition to current treatments, and clinical studies show that this can provide benefits on top of existing treatment. The NHS has led the rollout of Covid medicines, from the discovery of dexamethasone as the world's first effective treatment, to the first vaccination outside of a clinical trial in December 2020. The NHS said baricitinib works by reducing inflammation caused by Covid-19 by blocking signals to the immune system that are causing it to attack the body.

German biotechnology company BioNTech has signed a deal with the Department of Health and Social Care to enrol up to 10,000 patients in clinical trials by the end of 2030 for personalised cancer therapies, the German drug maker said. The multi-year collaboration is focused on cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding the company's footprint in the UK, BioNTech said in a statement on Thursday (January 5). Under the agreement, the parties plan to utilise UK's clinical trial network, genomics and health data assets, aiming to enrol the first cancer patient in the second half of 2023, the company said.

The National Institute for Health and Care Excellence (NICE) has recommended Enhertu for people with advance breast cancer. "There is not enough evidence yet to show how much longer people live with Enhertu compared with trastuzumab emtansine because the clinical trial is still ongoing. This means the cost-effectiveness estimates are highly uncertain and Enhertu cannot be recommended for routine use in the NHS," said NICE. The independent appraisal committee concluded that Enhertu could be cost-effective if further evidence from the ongoing trial and from NHS practice can show how much longer people live with treatment. Helen Knight, director of medicines evaluation at NICE, said: "Today's draft guidance is good news for people with this type of advanced breast cancer, who often experience severe and debilitating symptoms.

Three leading pharmacists - professor Mahendra Patel, Asif Aziz and Ade Williams - have been recognised in Queen Elizabeth's annual New Year's honours list. Professor Patel, an academic pharmacist from West Yorkshire, was awarded an OBE for his "services to pharmacy." He told Pharmacy Business: "I am truly honoured and deeply humbled by this highly prestigious award that I have always believed was more deserving for others. "That's not to say I'm not proud of it - far from it, although for me it's not necessarily about rewards and recognition but more the intricacies of the journey I embark on and the learning and joy that those encounters bring with it. Most recently, Professor Patel - who has had a broad ranging portfolio career spanning community pharmacy, health education and health promotion, academia, and research - has been involved in promoting clinical trials across community pharmacies in the UK. His latest work has seen him act as one of the national leads for the PRINCIPLE and PANORAMIC trials, run by Oxford University - both trials seek to pioneer repurposed and new drug treatments in the community to prevent hospitalisation due to Covid-19.

British pharmaceutical giant GSK said on Saturday (April 15) its oral antibiotic drug to treat uncomplicated urinary tract infections (uUTI) in female adults and adolescents met the main goals in late-stage trials. The drug, gepotidacin, in phase III trials, met its primary goals of being on a par or better than nitrofurantoin, the current standard of care for the treatment of uUTIs, the company said. GSK plans to submit results of the trials to the United States Food and Drug Administration for review later in the second quarter. The drug, if approved, could become the first new type of antibiotic, which is critically important for countering drug-resistant infections, to treat uUTIs in 20 years, the company said. "Gepotidacin, if approved, will offer a much-needed additional oral treatment option for patients at risk of treatment failure associated with resistance or recurrence of uUTI," Chris Corsico, senior vice president of development at GSK, said.

The Scottish Medicines Consortium (SMC) has accepted AbbVie's RINVOQ (upadacitinib) for use within NHS Scotland for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). Upadacitinib offers an additional treatment choice in the therapeutic class of janus kinase inhibitors. "Daily life with ulcerative colitis is difficult due to the debilitating and unpredictable nature of its symptoms", said Dr Jonathan Macdonald, Consultant Gastroenterologist at NHS Greater Glasgow and Clyde. "Clinical trials have shown that upadacitinib as a once daily pill controls symptoms in eight weeks for many patients and provided sustained responses at one year. The SMC's decision is good news for people with ulcerative colitis in Scotland as it provides an additional treatment option to help them gain control of their condition." The SMC decision is based on data from the induction studies U-ACHIEVE and U-ACCOMPLISH, as well as the Phase 3 U-ACHIEVE maintenance study, which demonstrated the efficacy of upadacitinib versus placebo in its ability to achieve clinical remission. The SMC's decision follows the granting of Marketing Authorisation for upadacitinib in UC in July 2022.

National Institute of Health and Care Excellence (NICE) has not recommended 'Tirzepatide', also known as Mounjaro, developed by Eli Lilly, in its draft guidance issued on Tuesday (27 June) for treating type 2 diabetes in adults alongside diet and exercise. The independent NICE committee recognised the importance of new treatment options given that fewer than two-thirds of the adults with type 2 diabetes have adequate glucose control when using current treatment options. Evidence submitted to the committee from clinical trials showed the use of tirzepatide at any dose resulted in better glucose control and lower weight compared with semaglutide or insulin therapy. The weight reduction was more pronounced with higher doses of tirzepatide, while the effect on glucose levels seemed less dose-dependent. Similar effects were observed against all GLP-1 receptor agonists in company's network meta-analysis, but this was uncertain. The committee have asked the company to provide more data to address the uncertainties in the clinical evidence, when compared to all relevant alternative treatments.

The National Institute for Health and Care Excellence (NICE) has recommended abemaciclib also called Verzenios, made by Eli Lilly, for people with hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence who have had surgery to remove their tumour. The clinical trial result showed that people having abemaciclib with hormone therapy had a more than 30 per cent better chance of their cancer not coming back following surgery compared with people having hormone therapy alone. Helen Knight, interim director of medicines evaluation at NICE, said: "Today's positive draft recommendation, which comes less than a month after abemaciclib received its licence, is fantastic news. The fact that we have been able to produce draft recommendations so quickly is testament to the success of our ambition to support patient access to clinically and cost effective treatments as early as possible. "Until now there have been no targeted treatments for people with this type of breast cancer. Abemaciclib with hormone therapy represents a significant improvement in how it is treated because being able to have a targeted treatment earlier after surgery will increase the chance of curing the disease and reduce the likelihood of developing incurable advanced disease."

The National Institute for Health and Care Excellence (NICE) has recommended elosulfase alfa for routine use in the NHS for the treatment of mucopolysaccharidosis type 4A (also known as MPS 4A and Morquio A syndrome). Elosulfase alfa, also called Vimizin and made by BioMarin, becomes the first disease modifying treatment recommended by NICE for routine NHS use for people with this rare, severely life-limiting condition. NICE's final draft guidance follows the collection of 'real-world' data from 69 people who received NHS-funded treatment since 2015 as part of a managed access agreement. Clinical trial evidence and data collected as part of the managed access agreement, along with expert clinical opinion, shows some long-term benefits with elosulfase alfa treatment which suggest it slows progression of MPS 4A.

EMA will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May 2014.

Developing a new medicine is a sophisticated and complex task which initially begins with the understanding of disease or condition as thoroughly as possible. At first, the researchers conduct studies in cells, tissues and animal models to determine whether the disease or condition can be influenced by new molecule.

The National Institute for Health and Care Excellence (NICE) has recommended faricimab as treatment option for adults with wet age-related macular degeneration or diabetic macular oedema. Thousands of people in England could benefit from the recommendation of a new drug that helps to treat two leading causes of sight loss and visual impairment. Faricimab is administered as an eye injection and is being recommended as an option for treating some adults with wet age-related macular degeneration (AMD) or with diabetic macular oedema (DMO). In the key clinical trials, aflibercept, another eye injection drug used to treat AMD and DMO, was administered every 8 weeks, while faricimab dosing, based on assessments of the disease activity, allowed for an interval of up to 16 weeks between doses, and was found to be equally effective. Up to 300,000 people in England with wet age-related macular degeneration (AMD) could be eligible to receive faricimab as part of their treatment alongside just over 28,000 people with diabetic macular oedema.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

The Association of the British Pharmaceutical Industry (ABPI) has laid out a series of urgent actions it wants the newly elected Labour government to implement within its first 100 days in office. Among the top priorities, the ABPI has emphasised the urgent need to appoint a new Chair and Chief Executive for the Medicines and Healthcare products Regulatory Agency (MHRA). Additionally, the ABPI has urged the new government to launch the Life Sciences Manufacturing Capital Grants Facility without delay. Other measures the ABPI wants Labour to prioritise include: Rapidly passing outstanding UK clinical trials legislation to enhance the UK's attractiveness for inward investment, including into research within the NHS. Increasing commercial flexibility in the NHS England Commercial Framework for New Medicines to remove barriers for companies to launch new medicines and indications so that NHS patients can access the latest innovative medicines.

All 42 integrated care boards (ICBs) in England have signed memorandums of understanding for the NHS Independent Prescribing Pathfinder programme, the first nationally-funded prescribing service in the country. Anne Joshua, interim deputy director of pharmacy commissioning at NHS England, made the revelation during the 'Chief pharmaceutical officer bi-monthly webinar' held on 7 March 2024, as reported by The Pharmaceutical Journal. In the initial phase of the programme, 210 community pharmacies across all ICBs will trial independent prescribing, ahead of establishing a commissioning framework for the service. Giving an update on the pathfinder programme, Joshua confirmed that 164 of these potential pathfinder sites had registered for the programme as of 29 February 2024. Additionally, she announced the clinical models to be followed by the participating pharmacies and presented a graph showing an overview of the services they will provide.

The Association of the British Pharmaceutical Industry (ABPI) has proposed a Voluntary Scheme for Pricing, Access and Growth (VPAG) that aims to deliver a sustainable approach to medicines provision and maximise the growth potential of the UK life sciences industry. It has published the industry's vision for a new agreement with the government which will deliver for patients, the NHS and the economy. VPAG also includes measures to ensure rapid patient access and adoption of new medicines, as well as opportunities to improve health outcomes and productivity for the whole country. The association's proposals consist of four key areas: restoring an internationally competitive commercial environment for life sciences; supporting UK clinical research and R&D; ensuring rapid patient access and uptake of new medicines; and improving population health and productivity through health innovation. The proposal would deliver over £1bn a year to the NHS - around £300m more than the average delivered under the old scheme before 2023, and comfortably more than the highest contributions ever made before the pandemic.

The US Food and Drug Administration has approved a US clinical trial of a lung cancer vaccine developed in Cuba. Already produced in Cuba for $1 per dose...

Fruit and vegetables contain a wide variety of antioxidant compounds (phytochemicals) such as phenolics and carotenoids that may help protect cellular systems from oxidative damage and lower the risk of chronic diseases. A recent study showed that the actions of the antioxidant nutrients alone do not explain the observed health benefits of diets rich in fruits and vegetables, because taken alone, the individual antioxidants studied in clinical trials do not appear to have consistent preventive effects. Read the full article.

The National Institute for Health and Care Excellence (NICE) has recommended first new treatment - 'romosozumab' for osteoporosis for over a decade. Thousands of people in England and Wales with severe osteoporosis who are at high risk of fracture are set to benefit from a new treatment - romosozumab - after NICE published the final draft guidance. Over 20,000 people could be eligible for the treatment according to the company. Clinical trial evidence showed that romosozumab (also known as EVENITY and made by UCB) followed by alendronic acid is more effective at reducing the risk of fractures than alendronic acid alone. Osteoporosis is a disease that causes bones to become thin and fragile. Many people with osteoporosis show no symptoms, but they may be at increased risk of fracture. Osteoporosis leads to nearly 9 million fractures around the world each year, and over 300,000 people per year attend hospitals in the UK with fractures caused by osteoporosis.

Global demand for Pfizer's oral Covid-19 antiviral treatment Paxlovid has been unexpectedly low due to complicated eligibility requirements, reduced testing, and potential for drug interactions, according to a media report. Demand also has been hampered by the perception that Omicron infections are not that severe. Paxlovid was expected to be a major tool in the fight against Covid after it reduced hospitalizations or deaths in high-risk patients by around 90 per cent in a clinical trial. Thousands of people still die from Covid-19 every week, even as global infections are far off their peak. And there are only a few proven antiviral treatments, of which Paxlovid is the most attractive. The others are Merck & Co's far less effective rival pill molnupiravir, and Gilead Sciences' intravenous remdesivir.