Search Results for “FDA” – Page 81 – media

Cell Stem Cell | Drug Sensitivity and Resistance Atlas of Sarcoma

Writing | My Best Friend Old Red Riding Hood Sarcoma is a rare heterogeneous stromal tumor. They mainly occur in bones and soft tissues, and have a particularly severe impact on young patients [1-3]. In the United States, about 13000 cases of soft tissue sarcoma and 4000 cases of osteosarcoma are diagnosed every year. Although the incidence rate is very low, the mortality rate is still high. For example, osteosarcoma is the third leading cause of cancer death in patients under the age of 20. The treatment plan varies depending on the subtype and stage of the disease, including surgical resection, chemotherapy, targeted systemic therapy, and in some cases, radiation therapy [4,5]. Although significant progress has been made in specific subtypes, current treatment methods rarely cure them. The overall 5-year survival rate for soft tissue sarcoma is 65%, and the overall 5-year survival rate for bone cancer is 50% -60% ...
- Source: drugdu
- 50
- October 23, 2024
RNA editing pioneers fought a comeback

“CRISPR gives way, RNA editing therapies are going to speed up.” This is the title of an article published in “Nauter” in February this year (“Move over, CRISPR: RNA-editing therapies pick up steam”). RNA editing technology, which is coming to the fore, is seen as having the potential to surpass CRISPR due to its safer and more flexible characteristics. The technology is in its infancy, and the bets of MNCs such as Eli Lilly and GSK have once pushed its popularity to a climax. However, Wave, an RNA editing pioneer founded in 2012, took more than 10 years to push its first RNA editing project WVE-006 into clinical trials. During this period, due to the clinical failure of other nucleic acid drugs, Wave’s stock price fell from a high of US$56 per share to around US$1 per share, and market expectations were no longer there. After years of silence, a ...
- Source: drugdu
- 61
- October 23, 2024
Astellas wins a belated victory

On October 18, the FDA announced the approval of the Claudin18.2 monoclonal antibody Vyloy (zolbetuximab) for marketing, and will use it as the first-line treatment for adult patients with locally advanced unresectable or metastatic gastric cancer with Claudin18.2-positive tumors, and HER2-negative gastroesophageal junction adenocarcinoma. With the announcement of this good news, zolbetuximab officially became the first anti-Claudin18.2 drug approved by the United States. This means that Astellas has taken the lead in this hot target. In the past few years, Claudin18.2 has been a hot target in the field of oncology, attracting the interest of giants such as AstraZeneca, Merck, and Moderna. Of course, the entrants also include many domestic pharmaceutical companies. However, in the face of many entrants, Astellas’s “defending” ability has also been extremely demanding. At present, it may not be easy for it to maintain its leading position. Zolbetuximab has always attracted much attention, and the core ...
- Source: drugdu
- 47
- October 23, 2024
400,000 patients don’t want to lose their bladders

Protecting the bladder is definitely a topic worth paying attention to for pharmaceutical companies. The core reason is that there are many patients who face the decision of whether to keep their bladders. Bladder cancer is the tenth most common cancer in the world, with more than 614,000 new cases of bladder cancer in 2022. About 70% of patients are initially diagnosed with non-muscle invasive bladder cancer (NMIBC), corresponding to a population of more than 400,000. According to the severity, NMIBC can be divided into carcinoma in situ (CIS) that only exists on the surface of the bladder, non-invasive papillary carcinoma (Ta), and tumors that invade the lamina propria (T1). Fortunately, bladder cancer has obvious early symptoms, which facilitates early detection and early treatment. In the past few decades, the standard treatment for NMIBC has been transurethral resection of bladder tumors (TURBT) plus postoperative adjuvant intravesical instillation of BCG. Unfortunately, ...
- Source: drugdu
- 41
- October 23, 2024
Yuyue Medical’s “wishful thinking”

The performance of the leading player ResMed fully reflects this point. In fiscal year 2024, ResMed’s equipment revenue alone reached US$2.444 billion. As another example of the “razor + blade” model, the revenue brought by home ventilators is not limited to equipment. In fiscal year 2024, in addition to equipment, ResMed’s consumables revenue reached US$1.657 billion, a year-on-year increase of 14%, which is much higher than the equipment; and ResMed also opened up the space for the SAAS business model, with revenue reaching US$584 million, a year-on-year increase of 17%. Under the three-wheel drive model of equipment, consumables, and software, ResMed’s total revenue in fiscal year 2024 reached US$4.685 billion and its net profit reached US$1.021 billion. In the huge medical equipment industry, such a scale is not considered the top, but it must not be ignored in the subdivided field. The outstanding performance of the leader naturally attracted the ...
- Source: drugdu
- 43
- October 23, 2024
90%! Pfizer’s RSV vaccine has significant efficacy in treating severe respiratory diseases

The new data released on Thursday at IDWeek provides a clearer picture of Abrysvo’s performance in preventing severe illness and hospitalization. The results came from Kaiser Permanente in Southern California, although the trial was funded by Pfizer and included co authors from Pfizer. This retrospective study observed patients aged 60 and above who were hospitalized or visited the emergency room due to severe acute respiratory disease. In this group, the effectiveness of the vaccine in preventing the most severe respiratory cases was 90%, with only one positive case found among patients who received the Abrysvo vaccine. The confidence interval is wide, ranging from 24% to 99% in preliminary analysis. Although the results were not significantly different from those shown by the company in previous trials, this study is the first to review individuals with compromised immune function as they were not included in the Phase 3 study. Despite the introduction ...
- Source: drugdu
- 57
- October 22, 2024
BeiGene PD-1 inhibitor BaiZeAn ® Approved for the 14th indication in China

Beijing, China – October 21, 2024- BeiGene Limited (NASDAQ: BGNE; Hong Kong Stock Exchange code: 06160; Shanghai Stock Exchange code: 688235), a global cancer treatment innovation company, announced today that its PD-1 inhibitor BeiGene An ® Teralizumab has been officially approved by the China National Medical Products Administration (hereinafter referred to as “NMPA”) for use in combination with platinum based chemotherapy as neoadjuvant therapy, and continues to be used as monotherapy for resectable stage II or IIIA non-small cell lung cancer patients after surgery. As the first PD-1 drug approved for neoadjuvant and adjuvant immunotherapy of stage II-III non-small cell lung cancer (NSCLC) in China, Trastuzumab provides a new option for perioperative treatment of operable lung cancer patients, helping them achieve longer survival benefits. This approval is based on clinical trial data of RATIONALE 315 (NCT04379635). This study is a multicenter, randomized, placebo-controlled, double-blind phase 3 study evaluating the efficacy ...
- Source: drugdu
- 53
- October 22, 2024
Innovative ophthalmic anti VEGF/complement drug clinical latest results announced

Biopharmaceutical Era October 21, 2024 10:04 Zhejiang Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On October 21, 2024, Xinda Biotechnology announced the Phase II clinical data of its recombinant human vascular endothelial growth factor receptor (VEGFR) – antibody human complement receptor 1 (CR1) fusion protein Efdamrofusp alfa injection (R&D code: IBI302) in neovascular age-related macular degeneration (nAMD) at the 2024 American Academy of Ophthalmology (AAO) Annual Meeting. This presentation attracted the attention of many attending experts and scholars. Phase II clinical study of IBI302 (anti VEGF and anti complement dual target drug) administered at long intervals in subjects with neovascular age-related macular degeneration The data released ...
- Source: drugdu
- 54
- October 22, 2024
Abbott joins the PFA melee

Recently, Abbott announced its latest progress in electrophysiology pulsed field ablation (PFA). Specifically, the global IDE registration of the Volt™ PFA system was completed ahead of schedule; the tactical flex™ Duo ablation catheter Sensor Enabled™ is undergoing the global FOCALFLEX trial; the Advisor™ HD Grid X mapping catheter Sensor Enabled™ has been approved by the US Food and Drug Administration and has begun commercial release. According to Abbott’s official website, the above two catheters are being developed as important tools for doctors to treat patients with abnormal heart rhythms such as atrial fibrillation (AFib). Among them, the mapping catheter will further support the mapping of PFA and radiofrequency ablation cases, and the visualization of cardiac anatomy is crucial for patients undergoing ablation surgery to achieve the best results. It is reported that the enrollment of the US VOLT-AF IDE study was completed 4 months ahead of schedule, and nearly 400 ...
- Source: drugdu
- 57
- October 22, 2024
【EXPERT Q&A】What is the process for medical device export?

Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
- Source: drugdu
- 61
- October 21, 2024

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