The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Yellow Card Biobank will begin investigating a new group of medicines to prevent strokes. First launched in partnership with Genomics England in June 2023, the Yellow Card Biobank will help to improve understandings of how genetic makeup can impact the safety of medicines and to improve personalised medicine approaches. Accumulated genetic data and patient samples will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse drug reactions (ADRs), which involve medicines and medical devices. In total, ADRs account for one in 16 hospital admissions in the UK and continue to be a significant burden on the NHS. In its second phase, the genetic biobank will begin investigating direct oral anticoagulants, such as apixaban, dabigatran, edoxaban and rivaroxaban. A stroke, responsible for more than 100,000 cases in the UK every year, occurs when the ...
The institute is one of two UK laboratories wholly funded by the MRC The Medical Research Council (MRC) has opened a new Laboratory of Medical Sciences (LMS), worth £120m, at Imperial College Healthcare NHS Trust’s Hammersmith hospital. The institute is one of two laboratories in the UK that is wholly funded by the MRC. Commissioned by the LMS with investment from Imperial College London, the new eight-story building houses 400 scientists who work across themes including genes and the environment, heart and metabolic diseases and sex-based differences in diseases. It was designed to amplify the institute’s ability to bridge the gap between scientists exploring fundamental biological mechanisms as well as those translating that work into clinical applications. Professor Wiebke Arlt, LMS director, takes a new approach to research with a challenge-led team science approach, designed to build dynamic collaborations around specific biomedical challenges, co-designed with a variety of stakeholders such ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant. The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards. The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards. The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally. The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage. MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged. The new authorisation by the MHRA is applicable only in Great Britain. The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 ...
In the UK, there are about 17,000 individuals living with sickle cell disorder, and each year there are around 250 new cases. This condition, predominantly affecting people of black African and Caribbean descent, can lead to significant organ damage and intense pain. In contrast, the UK has around 800 patients with thalassaemia and less than 50 new cases annually. Thalassaemia patients struggle to produce sufficient hemoglobin, which, if untreated, can result in life-threatening anemia. This condition is most prevalent among people of Asian, Middle Eastern, and southern Mediterranean backgrounds. While life-saving blood transfusions are a common treatment for these inherited blood disorders, about 20% of patients develop antibodies against certain blood groups, causing delays in their treatment. Now, a groundbreaking ‘blood matching’ genetic test, the first of its kind in the world, is being made available to thousands of these patients in the UK to better pair people for blood ...
DUNDALK, Ireland, Jan. 31, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully completed the first manufacturing run at its drug substance facility MFG7, paving the way for large-scale commercial manufacturing projects at this Ireland site. The manufacturing run reached 16,000-liter scale by combining four 4,000-liter single-use bioreactors. This pioneering paradigm marks not only the first successful manufacturing run for the MFG7 facility, but also the largest manufacturing scale for WuXi Biologics to date. The Cost of Goods (COGS) from this run is comparable to that of a 16,000-liter traditional stainless-steel bioreactor, reinforcing the comparable cost seen in over 100 runs at 12,000-liter scale single-use bioreactors (6×2,000-liter in MFG2 and MFG5 facilities; 3×4,000-liter in MFG5 and MFG8 facilities) compared with a traditional 12,000-liter stainless steel bioreactor. Dr. Chris Chen, CEO of WuXi Biologics, commented, “We ...
Drug shortages are continuing to persist in the UK affecting patients with different conditions, including those with type-2 diabetes who are on GLP-1 receptor agonists (GLP-1 RAs). Earlier this month, NHS England issued a National Patient Safety Alert regarding the shortage of GLP-1Ras. This was following a similar one issued in July 2023, which stated and that supplies were unlikely to stabilise sufficiently to meet market demand until at least mid-2024. In response to the January alert, the Diabetes UK issued a statement saying such shortages were being seen globally due to an increase in off-label use of semaglutide for weight loss. The alert issued actions to be taken by healthcare workers, such as only prescribing GLP-1 RAs for their licensed indications, and prescribing Rybelsus, another form of the GLP1RA semaglutide, for new treatment initiations and for those patients who can be switched from AstraZeneca’s Byetta (exenatide) and Novo Nordisk’s ...
Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
BY SEAN WHOOLEY The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet] Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. Medtronic, Tandem Diabetes Care and Beta Bionics also compete with Insulet in the automated insulin delivery space. Medtronic applauded automated insulin delivery recommendations from NICE last month. NICE’s guidance, published this week, outlines that the systems require less input from the user, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people’s quality of life. In a LinkedIn post from ...
The commitments will make health systems faster, simpler and fairer for patients Health and social care secretary Victoria Atkins has set out new priorities to improve the health and social care system in the UK. The new commitments intend to make the health and social care system faster, simpler and fairer for patients. As healthcare systems approach the winter season, Atkins has committed to ensuring that health and social care services are faster for patients by making it easier to get treatment locally, improving A&E performance and cutting waiting lists. She commits to making systems simpler for patients and staff with joined-up integrated care and reducing bureaucracy by giving them the latest technology to free up their time to care for patients. Furthermore, Atkins committed to making systems fairer by ensuring that children are protected from health harms; health outcomes are not determined by where people live; the government supports ...
Several pharmaceutical industry advocacy and lobby organisations have bandied together to release a joint industry statement supporting the Declaration on Climate and Health released at the ongoing COP28 meeting. The joint statement is from associations in Europe, US, Canada, and Japan, like the Association of the British Pharmaceutical Industry (ABPI), European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), as well as The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) which represents over 90 pharmaceutical companies worldwide. The declaration highlights the negative impacts of climate change on health, and details objectives to ensure better health outcomes, such as implementing adaptation interventions against climate-sensitive disease and health risks. The aim of the declaration is to strengthen the implementation of policies to protect populations most vulnerable to the health impact of climate change. The COP 28 meeting is an international gathering of national leaders, regulators, ...
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