Search Results for “research” – Page 36 – media

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
- 74
- 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
- 66
- 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
- 57
- 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
- 54
- October 23, 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
- 64
- 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
- 68
- October 22, 2024
Zhengda Tianqing’s Anlotinib Application for Ninth Indication Accepted by CDE

According to a report from Zhengda Tianqing, the company has recently submitted a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its self-developed Class I innovative drug, anlotinib hydrochloride capsules, in combination with chemotherapy for treating advanced unresectable or metastatic soft tissue sarcoma. This application has been accepted. Zhengda Tianqing noted that there are currently no officially approved combination therapies for first-line treatment of advanced soft tissue sarcoma globally. The Phase III clinical study (ALTN-III-04) evaluating the use of anlotinib hydrochloride capsules in combination with chemotherapy for first-line treatment of advanced unresectable or metastatic soft tissue sarcoma has achieved its pre-specified primary efficacy endpoint, as assessed by an Independent Data Monitoring Committee (IDMC). This study is the first key Phase III research globally to utilize an anti-angiogenic drug in combination with chemotherapy. At present, anlotinib hydrochloride capsules have received approval for six ...
- Source: drugdu
- 80
- October 22, 2024
Folagliptin benzoate tablets

According to the authoritative forecast of the International Diabetes Federation, the number of diabetes patients in China may increase to 174 million in 2045! This number really shocked the Chinese people. Are there really so many? You know, the number of diabetes patients in China in 2023 will reach 141 million, with an incidence rate of 12.8%. The number of diabetes patients in China ranks first in the world! In recent years, diabetes has become younger in China. According to a report in 2020, the prevalence of diabetes among residents aged 18 and above in China has reached 11.9%. This set of data once again sounded the alarm for the health of the Chinese people! You should know that diabetes is a chronic disease, and its typical symptoms are “three more and one less”. “Three more” means drinking more, eating more, and urinating more; “one less” mainly refers to weight ...
- Source: drugdu
- 60
- 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
- 87
- 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
- 86
- October 21, 2024

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