Search Results for “Clinical Trial” – Page 37 – media

When Hengrui Medicine “gave up” going overseas independently

Going overseas is not only a dream, but also a big adventure that Hengrui Medicine has to take. Even under the new measurement standards, there is such a voice that the success of going overseas will be the key to determining whether Hengrui Medicine can maintain its “number one” status. Indeed, Hengrui Medicine, which has accelerated its innovation transformation, has come to a crossroads. First, relying on the domestic market in the past, Hengrui Medicine may not be in a hurry to layout overseas markets. However, with the involution of domestic innovative drugs and pharmaceutical companies going overseas to find incremental growth, internationalization has also been raised to a more important level. Although Hengrui Medicine proposed the direction of “internationalization” as early as in its 2020 annual report, its internationalization has not been smooth in the past few years. Secondly, carrelizumab has already fallen behind, and the internationalization of PD-1 ...
- Source: drugdu
- 49
- October 24, 2024
Jixing Announces that the National Medical Products Administration has accepted the New Drug Marketing Authorization Application for Aficamten Tablets

October 18, 2024, Shanghai, China – Jixing Pharmaceuticals (hereinafter referred to as “Jixing”), a biotechnology company committed to bringing innovative science and drugs to patients suffering from serious life-threatening cardiometabolic diseases, today Announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration has officially accepted the new drug marketing application for Aficamten tablets for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is a new generation of selective small molecule cardiac myosin inhibitor under development. Its treatment of oHCM has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and the China National Medical Products Administration. This new drug marketing application is based on the positive results of the pivotal global Phase 3 clinical study SEQUOIA-HCM. A total of 282 patients with obstructive HCM were enrolled in SEQUOIA-HCM. The study results showed that treatment with Aficamten significantly improved patients’ exercise capacity ...
- Source: drugdu
- 45
- October 24, 2024
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
- 49
- 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
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
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
2.5 billion+2.3 billion! Sanofi adds more nuclear weapons

Original Xie Ling Arterial New Medicine October 18, 2024 08:27 Chongqing Yesterday (October 17th), Sanofi announced that it has reached an agreement with Orano Med, a subsidiary of the Orano Group, to further accelerate the development of next-generation radioligand therapy (RLT) by leveraging their expertise in combating rare cancers. According to the agreement, Sanofi and Oueno will jointly invest in a new entity operated under the Oueno Medical brand, focusing on the discovery, design, and clinical development of next-generation radioligand therapy (RLT) based on lead-212 (①¹² Pb) alpha emitting isotopes. Sanofi will make an equity investment of 300 million euros (approximately 2.313 billion yuan), accounting for approximately 16% of the equity of the new entity Orano Medical, with a valuation of 1.9 billion euros (approximately 14.648 billion yuan). At the beginning of last month, Sanofi announced a licensing agreement with RadioMedix and Orano Med for RLT, focusing on AlphaMedix, a ...
- Source: drugdu
- 68
- October 21, 2024

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