media – Page 218 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

Asieris Presents for the First Time Interim Analysis Data of Oral APL-1202 in Combination with PD-1 Inhibitor Tislelizumab for Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer at 2024 ASCO-GU

Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for the Phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632）at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed. Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, ...
- Source: drugdu
- 105
- January 30, 2024
NHS urges more young people to take up HPV vaccine

HPV is a common group of viruses which can sometimes lead to cancer The NHS is urging both parents and young people between the ages of 12 and 13 years to take up having the human papillomavirus (HPV) vaccine to meet the NHS cervical cancer elimination goal. New figures from the UK Health Security Agency have shown that around one in six girls and one in five boys are not fully vaccinated by year 10. HPV is a very common group of over 100 viruses which affect the skin, sometimes causing genital warts or cancer. The HPV vaccine works to protect against a variety of cancers, including cervical, head and neck, anal and genital cancers. It is currently offered to all 12- to 13-year-olds within schools and community clinics and requires parental consent to receive the vaccine from NHS nurses. New statistics from the UK Health Security Agency has shown ...
- Source: drugdu
- 136
- January 30, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 112
- January 30, 2024
J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee’s pricing hearing

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
- Source: drugdu
- 173
- January 30, 2024
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
- 99
- 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
- 186
- 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
- 234
- 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
- 110
- 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
- 99
- January 27, 2024
Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
- Source: drugdu
- 99
- January 27, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.