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Showing results for tags 'Pharma / Life sciences'.
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News ArticleThe world is “on the cusp of a first generation of treatments for Alzheimer’s disease”, experts have said, as a new drug was found to slow cognitive and functional decline. The drug donanemab, made by Eli Lilly and Company, slowed decline by 35% to 36% in a late-stage phase 3 clinical trial, the company said. Donanemab appeared to slow the decline associated with Alzheimer’s compared to placebo in 1,182 people with early-stage disease based on those with intermediate levels of a protein known as tau. The drug also resulted in 40% less decline in the ability to perform activities of daily living, according to the firm. Dr Susan Kolhaas, executive director of research and partnerships at Alzheimer’s Research UK, said: “This is incredibly encouraging, and another hugely significant moment for dementia research". “The treatment effect is modest, as is the case for many first-generation drugs, and there are risks of serious side effects that need to be fully scrutinised before donanemab can be marketed and used. “However, this news underlines the urgency of preparing the NHS to make these treatments available should regulators deem them safe and effective". Read full story Source: The Independent, 3 May 2023
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News ArticleChronically ill patients across the UK allege they've had to go without vital medication amid delays by a private company contracted by the NHS to deliver drugs. In the last year alone, Sciensus was awarded NHS contracts worth more than £5 million, despite being placed into special measures by health regulators in 2021 following widespread delivery failings. ITV News has revealed that the CQC is currently reviewing whether to take further regulatory action against Sciensus, having been made aware of concerns about the company’s performance. The company, which is based in Burton-on-Trent and says it "works with every NHS Trust in the country", should provide a lifeline for those who rely on specialised medications. These include those with long-term conditions - like cancer, HIV, and haemophilia - which often require drugs that can't be collected from high street or hospital pharmacies. One new mother with rheumatoid arthritis said she was taken to A&E after Sciensus left her without medication for three weeks. The 37-year-old, who wishes to remain anonymous, told ITV News: "I was unable walk with a small baby... it was such a chronic flare that I couldn't walk, which I've never, ever had before in my life." Read full story Source: ITV News, 21 April 2023
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Content ArticleElizabeth Holmes, the 38 year old founder of failed diagnostic start-up Theranos, was sentenced to more than 11 years in prison this November. The sentence was handed down nearly a year after she was found guilty of defrauding investors about her finger prick blood testing devices, and seven years after the Wall Street Journal published its first investigation exposing the company’s struggles. Theranos’ customers received false laboratory test results indicating life threatening conditions such as cancer and HIV. Patients were left to wait anxiously while traditional laboratories repeated the tests, and at least one customer stopped taking his medication on the basis of erroneous results. Holmes was ultimately not convicted of charges relating to patient harm, instead she will be locked up for misleading wealthy investors.
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Content ArticleThis report by LCP Health Analytics, looks at how inequalities across the medicine life cycle impact patients and populations. It paints a vision of what success could look like, and proposes specific, feasible calls to action across industry, health technology assessment (HTA) bodies and players that could transform the role of the life science sector in reducing inequalities and fostering healthy populations. The report identifies two key challenges in addressing health inequalities that are tractable, and where the life science sector is most likely to make commitments and contributions: Multimorbidity is increasing and embedding inequalities in health Financial incentives across health systems are not aligned with patient and population health
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News Article
Pill to prevent pre-eclampsia gets UK fast track for development
Patient Safety Learning posted a news article in News
A new pill that could prevent pre-eclampsia has become the first pregnancy drug to be fast-tracked for development by the UK’s drug regulator. Scientists at MirZyme Therapeutics, a biopharmaceutical company, believe they have developed a drug that when given to women from 20 weeks of pregnancy could stop them developing the condition. Pre-eclampsia endangers the lives of thousands of expectant mothers and their babies in the UK each year, and has no therapeutic options. Globally, it affects between 2% and 8% of pregnancies and kills up to half a million babies and 100,000 women a year. MirZyme Therapeutics has been awarded an innovative licensing and access pathway (ILAP), or so-called innovation passport, by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The passport was established in January 2021 to expedite access to essential new drugs at the height of the Covid pandemic. It is granted to medicines that address the needs of patients with life-threatening and unmet medical needs, with a view to getting the drug to the market as quickly as possible. Read full story Source: The Guardian, 8 November 2022 -
Content ArticleCorporate interests have the potential to influence public debate and policymaking by influencing the research agenda, namely the initial step in conducting research, in which the purpose of the study is defined and the questions are framed. Fabbri et al. conducted a scoping review to identify and synthesise studies that explored the influence of industry sponsorship on research agendas across different fields. The authors concluded that corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. The authors also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities.
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Content ArticleMedication errors harm patients and cost the NHS money – but with the right approach they can be significantly reduced. An HSJ article with Patrick Wilkinson and Nick Rodger from BD.
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Content ArticleAdopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries. In this webinar, you'll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges.
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Content ArticleIn this video of a plenary session from the Guidelines International Network (GIN) Conference on 26 October 2021, James McCormack, Professor at the Faculty of Pharmaceutical Science, University of British Columbia, discusses issues with clinical practice guidelines and ways to overcome them.
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Content ArticleTCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI]. We refer to it as an 'Open Registry Infrastructure' for medical devices. It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it. It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?) Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group. We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
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Content Article“Sunshine” policy, aimed at making financial ties between health professionals and industry publicly transparent, has gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be.
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Content ArticleA recent survey of over 1,700 patient groups around the world has revealed the true toll the COVID-19 pandemic has had on patient communities, with many individuals feeling more vulnerable, confused and uncertain about the consistency and continuity of their care. Now, more than ever, the life sciences industry has a responsibility to listen to the unique and changing needs of patients. They must continue to work with patient organisations on their vital work to safeguard continued access to treatment and to understand their need for holistic support ‘beyond the pill’. Dr Berkeley Phillips, Country Medical Director of Pfizer UK, explains in this article how Pfizer continues to partner with patient organisations across a broad spectrum of conditions from cancer to rare diseases, ensuring patients feel equipped, informed and empowered despite the uncertainty.
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Content ArticleNine out of 10 medical professional bodies think patients have a right to know if their doctor had financial or other links with pharmaceutical or medical device companies. Abi Rimmer considers the next steps towards implementing a mandatory register of doctors’ interests in the UK.
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Content Article
Pfizer: Medicine safety tips for patients
Patient Safety Learning posted an article in Medication
Medication errors can happen in clinics and hospitals, pharmacies, and at home. Patients and healthcare providers, however, can work together to help prevent these errors. See Pfizer's tips for patients. -
Content Article
ABPI: What is legitimate interests? (9 December 2021)
Patient-Safety-Learning posted an article in Good practice
Disclosure UK is the Database on which all pharmaceutical companies abiding by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice must disclose ‘transfers of value’ to healthcare professionals, other relevant decision makers and healthcare organisations in the UK. Where possible, companies do this by naming the individuals and organisations and according to GDPR law, companies must identify an appropriate lawful basis before they process an individual's information. This guidance document by the ABPI is aimed at pharmaceutical companies using Disclosure UK. It explains and promotes the choice of the basis of 'legitimate interests' for disclosure, with the aim of increasing transparency in the relationships between healthcare professionals, other relevant decision-makers and the industry. -
EventuntilThis FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing. Further information
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EventuntilThe Europe Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Register
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Content ArticleIn this blog post, Kath Sansom, founder of the Sling the Mesh campaign, looks at the issue of payments being made to doctors and lobby groups by pharma and medical tech companies. She argues that these payments are a patient safety concern as it can lead to doctors displaying bias in advising treatments, with benefits being overstated and risks downplayed. This is especially concerning when industry money is given to consultants or researchers trialling new treatments. Kath highlights an investigation carried out by the Observer into the issue and explains why Sling the Mesh have lobbied the UK Government for a UK Sunshine style payment act, which would allow the public to look up the names of doctors, surgeons and researchers to see if they have taken money from industry.
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Content ArticleUS endocrinologist Richard Plotzker shares a recent experience of buying over-the-counter medication from a grocery store. When he opened the outer packaging, the blister packs were empty apart from one pill in each being resealed by scotch tape. Richard called the manufacturer and returned the medication for investigation. He describes how the incident highlights the need to be vigilant about any unusual appearance in the packaging of medication.
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Content ArticleDoes your manufacturing facility experience an undesirable frequency of costly product losses? Are recurring operational issues impacting productivity and morale? Do people believe the causes of these production issues are ‘human error’? Do Quality Differently will show you: How to take a systems-based risk management approach to create more operational success. Practical examples to guide improvement in your operations. Ways to apply comprehensive approaches that reveal and address the combination of factors that influence performance outcomes.
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News Article
Harm to AstraZeneca jab’s reputation ‘probably killed thousands’
Patient Safety Learning posted a news article in News
Scientists and politicians “probably killed hundreds of thousands of people” by damaging the reputation of the AstraZeneca vaccine, according to an Oxford scientist who worked on the jab. Prof John Bell said: “They have damaged the reputation of the vaccine in a way that echoes around the rest of the world.” “I think bad behaviour from scientists and from politicians has probably killed hundreds of thousands of people – and that they cannot be proud of that,” he told a BBC Two documentary When the Oxford/AstraZeneca jab was rolled out in the UK government advisers recommended under-40s should be offered an alternative due to a link to very rare blood clots. Fears over the links to blood clots also led other countries, including Germany, France, Spain, Italy, the Netherlands, the Republic of Ireland, Denmark, Norway, Bulgaria, Iceland and Thailand, to pause their use of the vaccine. The AstraZeneca vaccine has also not played a significant role in the booster programme. The BBC reported it accounted for only 48,000 of the more than 37m booster doses given in the UK. Read full story Source: Guardian, 7 February 2022 -
News ArticleSeveral drug companies have been fined £35 million for colluding to raise the cost of an anti-nausea drug used by cancer patients, taking the total fines stemming from a Times investigation to £400 million. The price paid by the NHS for prochlorperazine 3mg dissolvable tablets rose by 700%, from £6.49 a packet to more than £51, between December 2013 and December 2017, costing the NHS an extra £5 million a year. The Competition and Markets Authority (CMA) has ruled that several companies broke the law by fixing the market and agreeing not to produce a rival version of the drug, which is used to treat nausea and dizziness and can be prescribed to patients having chemotherapy. Andrea Coscelli, chief executive of the CMA, said: “The size of the fines reflects the seriousness of this breach. These firms conspired to stifle competition in the supply of this important medication, so that the NHS — the main buyer of the drugs — lost the opportunity for increased choice and lower prices.” He said the CMA would not “hesitate to take action like this against any businesses that collude at the expense of the NHS”. Read full story (paywalled) Source: The Times, 3 February 2022
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News ArticleA French court has fined one of the country’s biggest pharmaceutical firms €2.7m (£2.3m) after finding it guilty of deception and manslaughter over a pill linked to the deaths of up to 2,000 people. In one of the biggest medical scandals in France, the privately owned laboratory Servier was accused of covering up the potentially fatal side-effects of the widely prescribed drug Mediator. The former executive Jean-Philippe Seta was sentenced to a suspended jail sentence of four years. The French medicines agency, accused of failing to act quickly enough on warnings about the drug, was fined €303,000. The amphetamine derivative was licensed as a diabetes treatment, but was widely prescribed as an appetite suppressant to help people lose weight. Its active chemical substance is known as Benfluorex. As many as 5 million people took the drug between 1976 and November 2009 when it was withdrawn in France, long after it was banned in Spain and Italy. It was never authorised in the UK or US. The French health minister estimated it had caused heart-valve damage killing at least 500 people, but other studies suggest the death toll may be nearer to 2,000. Thousands more have been left with debilitating cardiovascular problems. Servier has paid out millions in compensation. “Despite knowing of the risks incurred for many years, … they [Servier] never took the necessary measures and thus were guilty of deceit,” said the president of the criminal court, Sylvie Daunis. Read full story Source: The Guardian, 29 March 2021
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News ArticleHospitals across Europe, including Britain, as well as the Middle East and Africa are scrambling to replace millions of pieces of equipment used to treat patients, as fears grow that they could cause infections after a company was discovered to have falsified sterilisation records for more than a decade. The Independent has learned the problem affects more than 230 different types of infusion lines, connectors and associated kit, along with six infusion pumps used to deliver medicine and fluids into patients’ veins. Medical devices company Becton Dickinson, or BD, has issued a recall of six of its Alaris infusion pumps as well as related tubing and kit after an investigation found a company it uses was intentionally falsifying sterilisation records, meaning BD could not be certain the tubing and pumps were free from contamination. Hospitals across the UK have been given until the end of this month to stop using the pumps and quarantine any of the affected equipment. Any NHS trusts struggling with a lack of supply have been told to seek “mutual aid” from neighbouring trusts. Public Health England told The Independent it had not identified any large scale infections linked to the IV lines but said it could not rule out smaller isolated infections. Read full story Source: The Independent, 22 March 2021
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EventuntilHuman performance in pharmaceutical and biopharmaceutical manufacturing: successes and challenges to meaningful industry change Adopting the principles and practices of human performance has led to valuable business and safety performance improvements in high-risk high-consequence industry sectors, such as energy and aviation. Eager to realise similar levels of improvement, several companies in the pharmaceutical and biopharmaceutical manufacturing sector have begun the adoption of human performance within their operations. However, the unique industry context and regulatory environment of this sector has proven the adoption of human performance principles and practices to be more challenging and complex than simply copying from the successes of other industries. In this webinar, you’ll hear from industry professionals who will share their experiences and perspectives on human performance adoption value, successes and challenges. Register now for free Topics and presenters Chairs Dr Brian Edwards trained at Guy’s Hospital, London in hospital medicine and clinical research. He has worked for the Medicines Control Agency, Parexel and Johnson & Johnson, there as a deputy qualified person for pharmacovigilance. For the last 13 years, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK. Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors Group. He has recently been awarded a Fellowship with the International Society of Pharmacovigilance. Currently he consults for his own company, Husoteria Ltd. Julie Avery is former Global Lead for human factors at GSK, with over 20 years in Quality and Operational Excellence. As an independent practitioner, Julie now integrates human performance into existing systems strategically and tactically supporting business goals and KPIs. Julie leads the CIEHF Human Factors Pharmaceutical Manufacturing COP and is a Trustee of the CIEHF representing Associate Members. Topic 1: Why we focus on human performance James Morris, executive director at NSF Health Sciences, has over 30 years’ pharmaceutical operations experience in quality and manufacturing; He’s often leading consulting and training projects in investigation and CAPA management. Topic 2: How human performance reflects a way of thinking – beliefs and principles Amy Wilson has more than 20 years’ experience in biopharma manufacturing, focusing on human and organisational performance, operational excellence, risk management and technical training. John C Wilkes is Human Performance lead for biologics at AstraZeneca. He has more than 25 years’ experience in industry, in manufacturing operations, operational excellence, quality systems and quality control. Topic 3: In terms of internal challenges, how can we get out of our own way? Clifford Berry is head of business excellence for Takeda at its Massachusetts Biologics Operations site. He’s been a human and organisational performance practitioner for over 20 years, with experience in commercial nuclear electrical generation, electric transmission and distribution, and biopharma.
