Search Results for “EC” – Page 293 – media

US Senate committee interrogates big pharma on “outrageously high” drug prices

The Senate Health, Education, Labor, and Pensions (HELP) Committee grilled the CEOs of major pharmaceutical companies on what chairman Senator Bernie Sanders labelled “the outrageously high cost of prescription drugs” in the US. Despite intense interrogation, the CEOs made no solid commitments to improve drug prices in the US. The February 8 hearing allowed US senators to question the CEOs of Merck & Co (MSD), Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) about their drug prices in the US and potential solutions to target high costs. Sanders highlighted price discrepancies between the US and other countries, pointing out that the list price for MSD’s Keytruda (pembrolizumab) is approximately $191,000 in the US, but $112,000 in Canada. On the issue of differential pricing in different countries, BMS CEO Chris Boerner said that the lower prices in countries such as Canada reduced access to essential medications. He said that patients ...
- Source: https://www.pharmaceutical-technology.com/news/us-senate-committee-interrogates-big-pharma-on-outrageously-high-drug-prices/?cf-view
- 267
- February 15, 2024
Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated ...
- Source: https://www.pharmaceutical-technology.com/news/hemogenyx-gets-reprieve-as-fda-lifts-clinical-hold-on-aml-car-t-therapy/?cf-view
- 151
- February 15, 2024
International consortium identifies biomarkers for cardiovascular disease in diabetes

Type 2 diabetes is estimated to affect 462 million people worldwide An international academic consortium led by Johns Hopkins University, US, the Chinese University of Hong Kong and Lund University, Sweden, has identified 13 biomarkers that improve the ability to accurately predict the risk of cardiovascular disease in people with type 2 diabetes. The study was conducted by 23 experts across 11 countries as part of an international partnership between the American Diabetes Association and the European Association for the Study of Diabetes, the Precision Medicine in Diabetes Initiative. Estimated to affect around 462 million people globally, type 2 diabetes is a condition that causes too much sugar in the blood. Patients living with the condition are two times more likely to go on to develop cardiovascular disease compared to those without diabetes. Researchers reviewed and analysed the medical studies published from 1990 onward that investigated the differences between people ...
- Source: https://times.com/news/international-consortium-identifies-biomarkers-for-cardiovascular-disease-in-diabetes/
- 202
- February 15, 2024
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
- 109
- 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/
- 112
- 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/
- 96
- 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/
- 96
- 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
- 77
- 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/
- 93
- 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
- 211
- February 12, 2024

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