Search Results for “Clinical Trial” – Page 42 – media

Actively Exploring New Paths for Investment and Mergers, Potential New Drug Commercialization is Imminent

Recently, Sanyuan Gene, a company listed on the Beijing Stock Exchange, stated in discussions with investors that it will adhere to the principle of “prudent research and steady advancement.” The company aims to explore pathways for external investment and mergers centered around its main business direction. It plans to fully utilize various tools and platforms within the capital market to seek high-quality investment or merger targets that can synergistically develop across research, production, and sales, with the goal of achieving higher quality development in both serious medicine and therapeutic medicine markets. In the pharmaceutical sector, the development of innovative drug companies is a critical component of new productive forces and is receiving significant attention from capital markets. As a national-level specialized “little giant” enterprise, Sanyuan Gene has been deeply involved in the biopharmaceutical field for 32 years. Since its listing on the Beijing Stock Exchange, the company has actively responded ...
- Source: drugdu
- 89
- September 29, 2024
Johnson&Johnson’s application for marketing of bevacizumab injection (subcutaneous injection) has been accepted

Public information shows that this is a subcutaneous administration fixed combination of the EGFR/MET bispecific antibody amivantamab developed by Johnson&Johnson and recombinant human hyaluronidase. In June of this year, Johnson&Johnson submitted a biopharmaceutical approval application for subcutaneous injection of bevacizumab to the US FDA, for all indications of approved or submitted intravenous bevacizumab preparations, covering different types of non-small cell lung cancer (NSCLC). According to Johnson&Johnson’s previous press release, patients were able to complete the injection of the subcutaneous formulation within 5 minutes. Evantomab is a humanized EGFR/MET bispecific antibody. It has multiple anti-cancer mechanisms, not only blocking EGFR and MET mediated signaling, but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications. The intravenous formulation of this product was first granted accelerated approval by the FDA in May 2021, and has since been approved for multiple indications, including:  Adult patients with locally ...
- Source: drugdu
- 67
- September 28, 2024
Fosun Pharma achieves 100% control

On the same day of signing the Equity Transfer Agreement, Fosun Kate and Kite revised the original license agreement. According to the revised content, Fosun Kate has obtained exclusive rights to develop, produce, and commercialize Yikaida and Brexu Cel (Fosun Kate’s ongoing project FKC889) within the Kite license area (mainland China, Hong Kong, and Macau) and field (cancer treatment field). Kite will receive a tiered royalty fee of 7% to 13% of drug sales. For Fosun Kate’s pipeline assets, Kite has the right to receive a sales royalty of 2% to 4%. In addition, Fosun Pharma will increase its capital by $10 million in addition to the $27 million equity acquisition, to strengthen Fosun Pharma’s layout in the biopharmaceutical field. It is reported that four CAR-T therapies, including Achilles’ heel injection, have submitted application information in the upcoming 2024 national medical insurance negotiations. Kite, Fuxing Medicine and Gilead 2017 is ...
- Source: drugdu
- 64
- September 27, 2024
The CSRC encourages cross-border mergers and acquisitions of unprofitable assets, a new path for Biotech to enter the capital market?

On September 24, Wu Qing, chairman of the CSRC, said at a press conference of the State Council that in order to further stimulate the vitality of the merger and reorganization market, the CSRC has studied and formulated the “Opinions on Deepening the Reform of the Merger and Reorganization Market of Listed Companies” (“Six Mergers and Acquisitions”, hereinafter referred to as the “Opinions”), including supporting listed companies to transform and upgrade to new quality productivity, encouraging industrial integration, improving regulatory tolerance, and improving the transaction efficiency of the reorganization market. Among them, it is clearly stated that listed companies are strongly supported to carry out cross-industry mergers and acquisitions and acquisitions of unprofitable assets based on transformation and upgrading. This means that unprofitable biotech companies may usher in a new path to enter the capital market. At the meeting, Wu Qing said that mergers and acquisitions are major events in ...
- Source: drugdu
- 71
- September 27, 2024
Shiyao Group’s $1.195 billion overseas expansion, Claudin 18.2 ADC awarded FDA fast track certification

Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
- Source: drugdu
- 82
- September 25, 2024
Cardinal Health Acquires ION for $1.115 Billion

Recently, Cardinal Health, the world’s ninth largest medical device company, announced that it has signed a final agreement to acquire Integrated Oncology Network (ION) for $1.115 billion (approximately RMB 7.861 billion) in cash to expand its oncology services business. INO is an independent community cancer center operator with over 50 clinics, more than 100 suppliers, and over 1000 healthcare workers in 10 states across the United States. It provides comprehensive care services for communities in areas such as medical oncology, radiation oncology, urology, and diagnostic testing. After this acquisition, all assets of ION will be integrated into the Navista Cancer Care division of Gardenor, and ION’s clinics will also receive Navista’s artificial intelligence analysis capabilities, as well as PPS Analytics platform support previously acquired by Gardenor through the acquisition of Specialty Networks. Navista is a subsidiary of Gardenor, a cancer diagnosis and treatment department jointly established with oncologists and clinic ...
- Source: drugdu
- 84
- September 25, 2024
CHMP recommends H drug for EU market launch

Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai H drug Hans form ® It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company’s independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for ...
- Source: drugdu
- 73
- September 24, 2024
Edward Life Sciences launches global business layoffs

After Edward Life Sciences (hereinafter referred to as Edward) sold its intensive care business to Becton DickinsonMedical for $4.2 billion, a major global layoff has begun. Approximately 3% of employees will be affected by this layoff, and according to proportional calculations, about 540 employees will be laid off. Edward CEO Bernard Zovighian stated that employees affected by the global layoffs have received notice today that some employees may temporarily stay to assist with the transformation of the intensive care business, while others may find other jobs within the company. 30.4 billion yuan sale, 4500 employees join Becton Dickinson Edward is deeply engaged in the fields of global structural heart disease, intensive care, and surgical monitoring. Currently, he has multiple advanced products such as heart valves, cardiac intervention therapy equipment, cardiac monitoring equipment, and surgical tools. Among them, with the “world’s first successfully implanted artificial mitral valve”, Edward firmly occupies the ...
- Source: drugdu
- 66
- September 24, 2024
Breaking the domestic gap! New Pulse Medical opens a new era in the TAVR market

Domestic companies have created a new situation in the TAVR market and created a new market engine. On August 14, 2024, the State Food and Drug Administration officially approved the domestic Prizvalve transcatheter aortic valve system developed by New Pulse Medical. As the first self-developed balloon-expandable valve launched in China, the Prizvalve valve system is expected to be the first to break the import monopoly, effectively improve the quality of life, and quickly capture market share. Aortic valve disease mainly includes aortic valve stenosis and aortic valve regurgitation. With the deepening of aging, the prevalence of cardiovascular diseases (including aortic valve stenosis) continues to rise, and the number of patients with aortic valve disease in the world and China has increased year by year. This change has not only had a serious impact on the quality of life of patients, but also posed severe challenges to the medical system. Traditional ...
- Source: drugdu
- 55
- September 23, 2024
the dawn of treatment for multiple myeloma!

Original Medical Overview Medical Overview September 19, 2024 08:54 Shanghai Multiple myeloma (MM) is a blood cancer that, despite advances in treatment methods in recent years, remains an incurable disease. The traditional treatment options for MM include the combination of proteasome inhibitors (PIs), immunomodulators (IMiDs), and monoclonal antibodies (Mo Abs). Although these methods improve patient survival and progression free survival (PFS), with the emergence of treatment resistant clones, patients will eventually develop resistance to these treatments. Therefore, researchers are exploring new treatment strategies such as CAR-T cell therapy and bispecific antibodies, which activate immune T cells to kill tumor cells. Based on the review of bispecific antibodies and multiple myeloma published in the Blood Cancer Journal this month, let’s talk about the design, mechanism of action, current clinical trials, and future development directions of bispecific antibodies. 01 Bispecific antibodies and therapeutic targets Bispecific antibodies (BsAbs) are antibody constructs with two ...
- Source: drugdu
- 73
- September 21, 2024

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