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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/
- 106
- 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/
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- 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
- 113
- 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
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- 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/
- 109
- 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
- 247
- February 12, 2024
Vicore licenses idiopathic pulmonary fibrosis therapy to Nippon in Japan

Swedish biotech Vicore Pharma has entered an exclusive licensing agreement for the Japanese rights for its idiopathic pulmonary fibrosis (IPF) therapy C21 with Nippon Shinyaku. Vicore will receive a $10m upfront payment and will be in line to receive up to $275m in development and commercial milestone-based payments. The company will also be placed to get tiered royalties that extend into “the low 20s” based on annual net sales of C21 in Japan, as per a 9 February press release. As per the agreement, Nippon will hold exclusive rights to develop and commercialise C21 in Japan. The company will be responsible for operational and financial costs for developing C21 in the country. Nippon will also contribute financially to the Japanese trial sites and patients in the global late-stage development of C21. Following the news, Vicore’s stock was up over 18% in trading today. The company’s market ...
- Source: https://www.pharmaceutical-technology.com/news/vicore-licenses-idiopathic-pulmonary-fibrosis-therapy-to-nippon-in-japan/?cf-view
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- February 12, 2024
AstraZeneca posts 81% rise in FY 2023 profit after tax

AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for the fiscal year (FY) 2023 from $3.29bn in the previous year. Despite a $3.73m decline in the sales of Covid-19 medicines, the company’s total revenue for the full year 2023 grew by 6% to $45.81bn, up from $44.35bn in FY 2022. Excluding Covid-19 medicines, AstraZeneca saw a 15% increase in total revenue. The company experienced growth across oncology, where revenues rose by 21%, cardiovascular, renal and metabolism (a rise of 18%), respiratory and immunology (a rise of 10%) and rare disease (a rise of 12%). Reported earnings per share (EPS) stood at $3.84, an 81% increase from the $2.12 reported in the previous year. Core EPS, a key profitability measure, rose 15% to $7.26. The company’s earnings before interest, taxes, depreciation and amortisation also saw a notable increase of 47% ...
- Source: https://www.pharmaceutical-technology.com/news/astrazeneca-fy-2023-profit-after-tax/?cf-view
- 185
- February 12, 2024
Blood biomarkers in TGF-β pathway identify hidden liver cancer risk

A new research paper was published in Genes & Cancer on February 5, 2023, entitled, “Mechanistically based blood proteomic markers in the TGF-β pathway stratify risk of hepatocellular cancer in patients with cirrhosis.” Hepatocellular carcinoma (HCC) is the third leading cause of death from cancer worldwide but is often diagnosed at an advanced incurable stage. Yet, despite the urgent need for blood-based biomarkers for early detection, few studies capture ongoing biology to identify risk-stratifying biomarkers. In this new study, researchers Xiyan Xiang, Krishanu Bhowmick, Kirti Shetty, Kazufumi Ohshiro, Xiaochun Yang, Linda L. Wong, Herbert Yu, Patricia S. Latham, Sanjaya K. Satapathy, Christina Brennan, Richard J. Dima, Nyasha Chambwe, Gulru Sharifova, Fellanza Cacaj, Sahara John, James M. Crawford, Hai Huang, Srinivasan Dasarathy, Adrian R. Krainer, Aiwu R. He, Richard L. Amdur, and Lopa Mishra, from The Feinstein Institutes for Medical Research, Cold Spring Harbor Laboratory, University of Maryland, University ...
- Source: https://www.news-medical.net/news/20240209/Blood-biomarkers-in-TGF-ceb2-pathway-identify-hidden-liver-cancer-risk.aspx
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- February 12, 2024
A budget friendly bioprocess control station for microbial applications

Distek, Inc., a leader in laboratory pharmaceutical instruments for over 48 years, proudly presents the BIOne 250 Bioprocess Controller, designed for microbial applications. This latest model is a process optimized design of our well-established BIOne 1250 benchtop bioreactor system, offering an approachable solution to meet the nuanced requirements of advanced microbial bioprocessing. This new addition to the Distek bioprocessing instrument family is designed as a cost-effective solution for microbial bioprocess applications. Building on the success of the award-winning design of the BIOne 1250 controller, the BIOne 250 provides sophisticated functionality to laboratories and research facilities of all sizes. The controller retains the popular user interface of the BIOne 1250 via a remote PC or monitor. This unique capability supports the management of multiple bioreactors from a single central screen. A standout feature of the BIOne 250 is its scalability, accommodating the evolving needs of bioprocess applications, making it suitable for ...
- Source: https://www.news-medical.net/news/20240210/Discover-the-BIOne-250-A-budget-friendly-bioprocess-control-station-for-microbial-applications.aspx
- 104
- February 12, 2024

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