Search Results for “EC” – Page 299 – media

Drug shortages challenge type 2 diabetes patients in the UK

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 ...
- Source: drugdu
- 91
- January 30, 2024
Successful publication of 5-year long-term follow-up results of Phase III randomized controlled study of CD20 monoclonal antibody Hanlikang® in patients with primary diffuse large B-cell lymphoma

Hanlikang® (rituximab injection), the first CD20 monoclonal antibody independently developed by Henlius and also the first biosimilar in China, was officially approved for listing and registration by the State Administration of Pharmaceutical Affairs (SDPA) on February 22, 2019, which fills the gaps of the domestically-produced CD20 monoclonal antibody and domestic biosimilar market, and enables more Chinese patients to benefit from it! Recently, the 5-year follow-up results of patients in the Phase III study of Hanlikon® were officially published in the journal BMC Cancer (HLX01-NHL03 open-label extension study, NCT04491721). The results of the phase III HLX01-NHL03 study have demonstrated the bioequivalence of HLX01 (Hanlikon®, a rituximab biosimilar) compared to rituximab (Merovia®) in untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Here, we report 5-year follow-up results from an open-label extension study. Patients were randomly assigned to receive rituximab (Merova®) + cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 (Hanlikon®) + ...
- Source: drugdu
- 174
- January 30, 2024
【EXPERT Q&A】What are the procedures for exporting medical devices to Japan?

Drugdu.com expert’s response: Given your company’s plans to enter the Japanese market and previous export experience, we will skip the details on export qualifications. To market their products in Japan, medical device companies must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act). However, language barriers and complex certification processes pose challenges in the registration of medical devices in Japan. Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the government-authorized local authority, including product design, production, and key process information. Foreign manufacturers must register their manufacturing information with the PMDA (Pharmaceuticals and Medical Devices Agency). Process for PMDA Registration: 1.1 Preparation Stage. Determine the product classification (Class I, Special Control Class II, Class II, Class III, Class IV) and product JMDN code, select a Japanese Marketing Authorization Holder (MAH). 1.2 The manufacturer registers the factory with PMDA. 1.3 Class II Special Control ...
- Source: drugdu
- 215
- January 29, 2024
New Tests to Help Predict Disease Progression in Ulcerative Colitis

Ulcerative colitis, a type of inflammatory bowel disease, progressively damages the gut lining. It leads to inflammation and ulcers in the colon and rectum. Currently, the initial treatment for mild-to-moderate cases typically involves 5-Aminosalicylates (5-ASA), while more advanced stages are managed with steroids, immunosuppressants, and biological drugs. There is an urgent need for accurate biomarker-based methods to quickly identify the most effective treatment plans post-diagnosis. Now, a new collaboration aims to personalize treatments for ulcerative colitis, ultimately enhancing the quality of life for those affected by the condition. RCSI University of Medicine and Health Sciences (Dublin, Ireland) and diagnostics company Serosep Ltd. (Limerick, Ireland) have joined forces to expedite the development of innovative tests to predict disease progression in individuals with ulcerative colitis. This initiative will focus on developing technology to identify patients whose condition is likely to worsen. The goal is to ensure individuals receive the most beneficial care ...
- Source: drugdu
- 93
- January 27, 2024
First of Its Kind Software Uses AI and ML for Personalized Disease Prediction

Currently, no artificial intelligence (AI) or machine-learning tools are available for investigating and interpreting the complete human genome, particularly for non-experts. Now, a first-of-its-kind software combines AI and machine-learning approaches to understand the importance of specific genomic biomarkers to predict diseases in individuals. The IntelliGenes software created by researchers at Rutgers Health (New Brunswick, NJ, USA) combines conventional statistical methods with cutting-edge machine learning algorithms to generate personalized patient predictions and provide a visual representation of the biomarkers significant to disease prediction. IntelliGenes has been designed in such as way that the platform can be used by anyone, including students or those lacking strong knowledge of bioinformatics techniques or access to high-performing computers. In a study, the researchers demonstrated how IntelliGenes can be deployed by a wide range of users to analyze multigenomic and clinical data. In another study, the researchers applied IntelliGenes to discover novel biomarkers and predict cardiovascular ...
- Source: drugdu
- 90
- January 27, 2024
Key Trends from the 2024 J.P. Morgan Healthcare Conference

Key trends such as the resilience of the emerging biopharma space, the complexities of Medicare, and the revolutionary role of data and AI are shaping the future of the industry. By SUJAY JADHAV Beneath the Californian sunshine (and a few showers) at JP Morgan, a revolution simmers. Not a political one, but a healthcare revolution propelled by necessity and fueled by innovation. Imagine a future where groundbreaking therapies reach patients years sooner, personalized treatments offer hope for chronic diseases, and healthcare costs become more manageable for everyone. This isn’t science fiction; it’s the promise of the cutting-edge trends made at the annual J.P. Morgan Healthcare Conference earlier this month. For those that attended JPM in early 2023, you may recall it was quite gloomy coming off of a soft 2022 and an interest rate burdened 2023. JPM 2024 had an air of optimism. Emerging biopharma space: Challenges and innovations One ...
- Source: drugdu
- 86
- January 27, 2024
Announcement of AOSAIKANG Pharmaceuticals on the Completion of Registered Clinical Phase III Study of its Subsidiary’s Bio-Innovative Drug ASKB589 in the First Patient in China

(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
- Source: drugdu
- 95
- January 27, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 98
- January 26, 2024
Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
- Source: drugdu
- 84
- January 26, 2024
Announcement on the Acceptance of Application for Clinical Trial of 20-valent Pneumococcal Polysaccharide Conjugate Vaccine

Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
- Source: drugdu
- 85
- January 26, 2024

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