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FDA grants breakthrough status to J&J’s nipocalimab for HDFN

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
- Source: https://www.pharmaceutical-technology.com/news/fda-breakthrough-jj-nipocalimab/?cf-view
- 111
- February 14, 2024
Innovate UK grants funds for breast cancer therapy project

Innovate UK has awarded a £1m ($1.26m) grant for a collaborative initiative called AI-VISION to aid treatment decisions for breast cancer patients. The project involves the Institute of Cancer Research (ICR), Durham University, the Royal Marsden Hospital and techbio company Concr. It will support clinical decision-making, including directing breast cancer patients on the use of immunotherapy. AI-VISION is a 24-month observational clinical study to assess tissue samples from early triple-negative breast cancer (TNBC) patients. These subjects will be analysed to define and establish chemotherapy response biomarkers, irrespective of immunotherapy status. The study aims to validate the safety and performance of new computational methods to offer precision therapies for patients. Concr will apply Bayesian computational frameworks, inspired by astrophysics, to interconnect diverse oncology data, enabling researchers to detect and develop biomarkers indicative of drug response. The ICR will contribute genomic data from its genomics facility, which will be integrated with clinical ...
- Source: https://www.pharmaceutical-technology.com/news/innovate-uk-funds-breast-cancer/?cf-view
- 105
- February 14, 2024
NHS launches Pharmacy First to treat seven common conditions

Over 10,000 pharmacies in England will be offering the new advanced service The NHS has announced the launch of Pharmacy First, which allows patients in England to receive treatment for seven common conditions without needing to see a GP. Approximately 10,265 community pharmacies in England will be offering the new advanced service. From today, patients in England will be able to receive treatment for sinusitis, sore throat, earache, infected insect bite, impetigo, shingles and uncomplicated urinary tract infections in women under the age of 65 without needing a GP appointment or prescription. Community pharmacies play a vital role in keeping local communities in England healthy. The NHS has said that the new service will free up to ten million GP appointments by this winter. “This is all part of [a] major transformation in the way the NHS delivers care, [which will give] people more choice in how they can access ...
- Source: https://healthmedia.blog.gov.uk/2024/02/01/pharmacy-first-what-you-need-to-know/
- 119
- February 14, 2024
MRC Laboratory of Medical Sciences worth £120m opens on ICL campus

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 ...
- Source: https://pharmatimes.com/news/mrc-laboratory-of-medical-sciences-worth-120m-opens-on-icl-campus/
- 103
- February 14, 2024
Everly Health Partners With National Kidney Foundation, Expands Kidney Health Testing Suite

Everly Health is teaming up with the National Kidney Foundation to improve education around chronic kidney disease, the company announced Monday. In addition, Everly Health is also expanding its diabetes monitoring and kidney health testing suite for health plans and employers. Austin, Texas-based Everly Health is a digital health company for remote diagnostics and managing health conditions. It has three brands: Everlywell, which offers direct-to-consumer at-home health tests; Natalist, which offers fertility and pregnancy products; and Everly Health Solutions, which works with health plans and employers by providing at-home lab tests and virtual care to members and employees. Through the partnership between Everly Health and the National Kidney Foundation, the two organizations will have co-branded educational information about the importance of kidney health screening. Everly’s health plan customers will identify the patients who are at risk of chronic kidney disease, such as being diagnosed with diabetes. Everly Health will ship ...
- Source: https://medcitynews.com/2024/02/kidney-disease-home-testing/
- 101
- February 13, 2024
Why One Google Cloud Exec Thinks HHS’ New Cybersecurity Guidelines Are A Step In The Right Direction

Cyberattacks remain a formidable threat to healthcare providers, with hackers’ tactics getting more sophisticated by the day. Policymakers are trying to combat this. For example, New York Governor Kathy Hochul released a proposed set of cybersecurity regulations in November that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. And a couple weeks ago, HHS published guidance outlining voluntary cybersecurity performance goals for the healthcare sector. While this initial guidance is voluntary, these goals will likely be used to inform upcoming HHS rulemaking. In its guidance, HHS outlined 10 key goals for strengthening providers’ cybersecurity: mandating basic cybersecurity training, mitigating known vulnerabilities, boosting email security, using multifactor authentication, ensuring strong encryption, requiring unique credentials, revoking credentials for departing workforce members, separating user and privileged accounts, establishing incident response plans, and vetting vendors’ cybersecurity. These guidelines are a starting point toward a more secure and ...
- Source: https://medcitynews.com/2024/02/google-cloud-hhs-cybersecurity/
- 106
- February 13, 2024
MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

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 ...
- Source: https://www.pharmaceutical-technology.com/news/mhra-licence-pfizer-biontech-vaccine/?cf-view
- 101
- February 13, 2024
Alys Pharmaceuticals announces launch with $100m funding

Alys Pharmaceuticals has announced its launch with a research and development (R&D) immuno-dermatology focused pipeline backed by a $100m financing from Medicxi. Co-founded by Medicxi and a team of dermatology and scientific specialists, Alys Pharmaceuticals is led by co-founder and COO Thibaud Portal, with Medicxi’s Francesco De Rubertis serving as board chairman. The company’s pipeline is powered by multiple platform technologies, targeting a range of dermatological ailments. Its goal is to transform the dermatological treatment landscape, focusing on conditions such as atopic dermatitis, vitiligo, alopecia areata and chronic spontaneous urticaria. Alys Pharmaceuticals’ pipeline also includes programmes for less common ailments such as mastocytosis and cutaneous T-cell lymphoma, and therapies to prevent skin side effects from cancer treatments. The company is partnering with establishments including the Institut Gustave Roussy and UMass Chan Medical School to advance its collaborative R&D. Alys Pharmaceuticals integrates the platforms and assets from six Medicxi companies: Aldena ...
- Source: https://www.pharmaceutical-technology.com/news/alys-pharmaceuticals-announces-launch/?cf-view
- 78
- February 13, 2024
Cancer treatment could identify patients most likely to respond to cancer drugs

Tumours with high mtDNA mutations more likely to respond to Opdivo Scientists from the Cancer Research UK Scotland Institute and Memorial Sloan Kettering Cancer Centre have discovered a cancer treatment that can identify patients who are more likely to respond to cancer drugs. Funded by Cancer Research UK and published in Nature Cancer, the study reveals new ways to identify patients who could benefit most from immunotherapy testing for mitochondrial DNA mutations (mtDNA). Researchers rewired the DNA of the mitochondria – energy factories found in living cells – to determine cancer responses to treatments that harness the body’s natural defences to attack cancer cells. Found in up to 50% of all cancers, mtDNA mutations cause mitochondrial dysfunction, which affects adenosine triphosphate levels – the source of energy for use and storage at the cellular level – as well as other cellular processes, leading to neuronal loss. Researchers found that tumours with ...
- Source: https://actionkidneycancer.org/cancer-treatment-could-identify-patients-most-likely-to-respond-to-cancer-drugs/
- 97
- February 13, 2024
【EXPERT Q&A】What is the process for exporting medical devices to the UAE?

Drugdu.com expert’s response: The specific steps and requirements for exporting medical devices to the UAE include: Product Compliance Assessment: Ensure that the medical device complies with the specific standards of the UAE, including safety, efficacy, and quality control. Obtain international certifications such as the CE mark or FDA approval. Registration with the UAE Ministry of Health: Submit an application for medical device registration to the UAE Ministry of Health. This includes submitting detailed documents such as product descriptions, safety and efficacy data, and technical files. Choosing an Authorized Agent: Select an authorized agent in the UAE responsible for handling registration, import, and distribution matters. Ensure that the agent has a legal operating license and a good market reputation. Labeling and Instructions for Use: The product labels and instructions for use should meet the language requirements of the UAE (usually in Arabic and English) and include necessary product information such as ...
- Source: drugdu
- 228
- February 12, 2024

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