Search Results for “FDA” – Page 82 – media

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
Huawei enters the hot track of medical devices

Recently, the website of the State Intellectual Property Office updated a new invention patent, named “Method for controlling stimulator, stimulator, brain-computer interface system and chip”, and the inventor of the patent is Huawei Technologies Co., Ltd. It is reported that this is Huawei’s second brain-computer interface related patent. As early as June 2023, Huawei announced a patent called “A brain-computer interface device and information acquisition method”. Brain-computer interface is one of the most popular phenomenal technologies in recent years, and its potential in the medical field is highly expected by the industry. According to McKinsey’s calculations, the potential market size of global brain-computer interface medical applications is expected to reach US$40 billion in 2030, and it is expected to exceed the US$145 billion mark by 2040. With the increase in R&D investment, the medical application of brain-computer interface has gradually shifted from early abstract concepts to landing results. In September, ...
- Source: drugdu
- 61
- October 21, 2024
RNA editing pioneers fought a comeback

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 a 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 met. After years of silence, a counterattack driven by clinical data is taking place. On October 16, Wave ...
- Source: drugdu
- 60
- October 19, 2024
2.5 billion! Haoluo Jie has obtained the world’s only uterine ablation product

On October 15th, Hologic Corporation (hereinafter referred to as Hologic) announced that it had reached a final acquisition agreement with Gynesonics for approximately $350 million (approximately RMB 2.5 billion). With this acquisition, Haoluo Jie will further expand its layout in women’s health products to consolidate its leading position in global women’s health. Acquiring innovative products The Gynesonics company acquired this time is an innovative women’s healthcare company headquartered in California, USA. Since its establishment in 2005, we have been committed to providing safe and effective minimally invasive treatment solutions for women with symptomatic uterine fibroids. The Sonata system, the core product of Gynesonics, is the world’s first and only FDA approved diagnostic intrauterine imaging device that can treat specific symptomatic uterine fibroids, including fibroids associated with severe menstrual bleeding, through the cervix. This is also the purpose of Haoluo Jie’s huge investment in acquisition.  The Sonata system consists of ...
- Source: drugdu
- 52
- October 19, 2024
Bankruptcy and divestment, breathing giant achieves rebirth

Recently, Zoll announced that it has completed the previously announced acquisition of some assets of Vyaire Medical’s ventilator business. In August of this year, these two companies announced this transaction after Vyaire initiated Chapter 11 bankruptcy proceedings. Now that the dust has settled on the acquisition, Zoll will launch Vyaire’s Bellavista, Fabian, LTV, and 3100 HFOV series of ventilators, further expanding its respiratory care product line. It is worth mentioning that Vyaire was an important force in the supply of ventilators during the early stages of the COVID-19 pandemic, but applied for bankruptcy protection due to operational difficulties. And Medtronic also chose to withdraw due to the fact that its ventilator business is no longer profitable. Zoll’s acquisition undoubtedly brings new vitality and hope to the market. 01. The rise and fall of rising stars in ventilators Zoll stated that the acquired product line of ventilators and their related consumables, ...
- Source: drugdu
- 64
- October 18, 2024
WuXi AppTec frequently mentioned this word during its Investor Day. Where does the confidence come from?

Recently, WuXi AppTec held an investor open day event called “CRDMO Ultimate Empowerment Journey”. At the event, WuXi AppTec executives mentioned the word “far ahead” many times. Although they said it with a calm face, the message they conveyed was “low-pitched and high-profile”, which won many applause and laughter from the audience. Why can they say that? Where does the confidence come from? If you really achieve “far ahead”, what is the secret? I just came back from WuXi AppTec’s investor day event, and I will highlight the key points for you. Both quantity and quality, the industry contribution is “far ahead” From the perspective of molecular types, the current research and development of small molecules is still the “main force” of current research and development and listing. Whether it is the number of drugs approved by the US FDA or the number of molecular pipelines under development, small molecules ...
- Source: drugdu
- 59
- October 18, 2024
Dano Pharmaceuticals announces over 300 million RMB E-round financing to accelerate the late stage clinical development and commercialization of core new drug products | Aurora Family

Danuo Pharmaceutical On October 16, 2024, Danno Pharmaceutical, an investment company of Aurora Borealis, announced the completion of the first batch of delivery for over 300 million RMB in Series E financing. This round of financing is jointly led by Zhongshan Venture Capital and AMR Action Fund, a subsidiary of Zhongshan Investment Holdings. The funds obtained will be used to support the core new drug research and development pipeline, including the late stage clinical trials and commercialization of TNP-2198, a new drug candidate for treating Helicobacter pylori infection, and TNP-2092, a new drug candidate for treating implanted medical device infection. Dr. Ma Zhenkun, founder, chairman, and CEO of Danno Pharmaceuticals, said: We are delighted to receive support from Zhongshan Venture Capital and AMR Fund. Danno Pharmaceuticals is committed to addressing the dual challenges of bacterial resistance and tolerance, providing solutions for bacterial infections and metabolic related diseases that still lack ...
- Source: drugdu
- 59
- October 17, 2024
Hengrui Medicine’s PD-1 combination therapy is re-registered for listing in the United States

On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
- Source: drugdu
- 55
- October 17, 2024
Partners with 10 Indian AI Startups

Novo Nordisk recently partnered with 10 Indian artificial intelligence (AI) startups, marking an important moment for the Indian AI ecosystem. The Danish company, best known for its weight loss drug Wegovy, is leveraging AI innovations to streamline operations and improve efficiency. The moves are part of the Danish drugmaker’s expansion plans for operations in Bangalore, which it opened 17 years ago. The center helps manage the vast amounts of data collected about the safety and effectiveness of its drugs, including clinical trial information and reports of potential side effects. One of the factors driving the move is that demand for obesity and diabetes-related drugs is expected to grow, especially as global attention to these health issues grows. By strategically positioning itself in India, one of the world’s largest markets for diabetes drugs, Novo Nordisk expects to meet the growing demand by increasing its production capacity. The partnership also has a ...
- Source: drugdu
- 56
- October 17, 2024
Collaborating with 10 Indian AI startups

These measures are part of the business expansion plan launched by this Danish pharmaceutical company in Bangalore 17 years ago. The center helps manage a large amount of data collected regarding the safety and efficacy of its drugs, including clinical trial information and potential side effect reports. One of the factors driving this initiative is that the demand for obesity and diabetes related drugs is expected to grow, especially with the increasing global attention to these health problems. Through strategic positioning in India (one of the world’s largest diabetes drug markets), Novo Nordisk is expected to meet the growing demand by improving its production capacity. This partnership has also had a broader impact on the operations of Novo Nordisk. It is expected that Novo Nordisk’s Bangalore center will become an approximate mirror of its Danish headquarters within three years. The company plans to increase the number of employees in Bangalore ...
- Source: drugdu
- 54
- October 16, 2024

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