PharmaFocus Today – Page 57 – media

Optical equipment giant, entering the ‘ophthalmic metaverse’

Recently, optical giant Zeiss announced that it has reached a cooperation agreement with Swiss AR/VR company Creal to jointly develop a new digital vision healthcare platform based on light field display technology, planning to completely revolutionize existing vision diagnosis and treatment procedures. Light field display is a method that utilizes ray tracing to reconstruct 3D scenes in space, and is currently the most likely practical 3D display technology. Compared with holographic display technology, which is also a true 3D display technology, light field display has smaller data volume, lower cost, and smaller volume. Zeiss will introduce CREAL’s light field display technology to create a device that can digitally reproduce real refractive testing. The new device will be able to virtually simulate traditional glasses and contact lenses, eliminating the need to switch lenses repeatedly. Objects in front of us will be displayed at different focal lengths, and through precise digital imaging, ...
- Source: drugdu
- 62
- September 12, 2024
Lianying ranks first in domestic production

Recently, the US FDA updated the list of authorized artificial intelligence and machine learning (AI/ML) medical devices. This list is a barometer of the health status of the artificial intelligence industry, and updates show that the FDA is maintaining a rapid pace of authorization. In the past few years, the FDA’s AI authorization has maintained double-digit growth, which reflects the increasing number of submissions received by the FDA from AI developers. AI/ML medical equipment explosion In the past, the FDA usually updated the list of approved AI/ML devices once a year, but with the frequent changes and approvals of artificial intelligence technology, the FDA has increased the frequency of updating the list. This list update includes 61 new approvals, including products approved between March 31st and June 25th. Similar to previous updates, applications targeting radiology accounted for the majority of the new licenses, with 44 products on the list since ...
- Source: drugdu
- 98
- September 11, 2024
Donated 160 million yuan to the Qinghai-Tibet Plateau

Under the guidance of the Central United Front Work Department, the Beijing Tongxin Gongzhu Public Welfare Foundation’s “Together, Forge a Chinese Heart” fund launched the 2024 “Together, Forge, Warm the Plateau” series of donation activities on the 5th, sending medical supplies worth 163 million yuan to the people in the Qinghai-Tibet Plateau. In early July, the Beijing Tongxin Gongzhu Public Welfare Foundation invited more than 800 medical experts from the capital, including Dong Jiahong, an academician of the Chinese Academy of Engineering, and Wang Jianliu, secretary of the Party Committee of Peking University People’s Hospital, to Ganzi Tibetan Autonomous Prefecture, Sichuan Province to carry out the “Together, Forge a Chinese Heart” medical charity event. The event lasted for one week, and 90 free clinics were set up in 18 counties (cities) in Ganzi Prefecture, with 73,000 free clinics, 10.8 million yuan worth of medicines distributed, and 52 operations such ...
- Source: https://mp.weixin.qq.com/
- 111
- September 11, 2024
The world’s first! Kangfang Biological Double Anti First Line Treatment for NSCLC Defeats K-Drug

On September 8, 2024, Kangfang Biotechnology announced at the 2024 World Lung Cancer Congress the heavyweight research data of the registered Phase III clinical trial (HARMONI-2/AK112-303) of the company’s independently developed global first PD-1/VEGF bispecific antibody new drug, Ivoxidan, compared to pembrolizumab monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression positive (PD-L1 TPS ≥ 1%). Ivoxidan became the world’s first drug to demonstrate significantly better efficacy than pembrolizumab in a single drug head to head Phase III clinical trial. Affected by this news, the stock price of Kangfang Biotechnology has risen by 14%. AK112-303/HARMONI-2 (CTR20222137) is a registered phase III randomized, double-blind clinical trial conducted in China to evaluate the first-line treatment of locally advanced or metastatic NSCLC with PD-L1 expression positive (PD-L1TPS ≥ 1%) compared to Ibuprofen (PD-1/VEGF) monotherapy. The primary endpoint was PFS assessed by IRRC according to ...
- Source: drugdu
- 98
- September 11, 2024
635 million US dollars! Anmai Biological BCMA × CD3 Double Antibody Successfully Goes to Sea

Anmai Biotechnology announced that it has reached a licensing agreement with Vignette Bio for the T cell conjugation (TCE) molecule EMB-06 targeting BCMA. According to the agreement, Amway Bio will grant Vignette the exclusive right to develop and commercialize EMB-06 outside the Greater China region (including Chinese Mainland, Hong Kong, Macao and Taiwan), and Amway Bio will reserve the right of EMB-06 in the Greater China region. Anmai Biotechnology will receive a total down payment of $60 million in cash and Vignette equity, and will have the right to receive up to $575 million in milestone payments for development, listing, and commercialization, as well as revenue sharing based on net sales. EMB-06 is the first TCE molecule developed under the T cell conjugation platform of Anmai Biotechnology, which combines Anmai Biotechnology’s self-developed FIT Ig bispecific antibody platform and CD3 binding domain library, as well as Anmai Biotechnology’s internal new drug ...
- Source: drugdu
- 77
- September 11, 2024
The first domestic new drug for alopecia areata is about to be launched

Recently, Hengrui Medicine announced that its application for marketing authorization of emasitinib sulfate tablets (SHR0302 tablets) was accepted by the National Medical Products Administration for the treatment of severe alopecia areata in adults. It is the first domestic JAK inhibitor to be accepted for marketing approval for alopecia areata indications in China. This also means that after Eli Lilly and Pfizer products have been approved in China, Hengrui is likely to become the first domestic company to enter the domestic alopecia areata market. Severe alopecia areata in adults is the fourth indication reported by emasitinib. Last year, it also reported moderate to severe atopic dermatitis, ankylosing spondylitis, and moderate to severe active rheumatoid arthritis in adults and adolescents aged 12 and above. Referring to the progress of Pfizer’s application for listing of Litixitinib Capsules accepted by the National Medical Products Administration in September 2022, included in the ...
- Source: https://mp.weixin.qq.com/
- 91
- September 11, 2024
cochlear implants and other high-value medical supplies will be included in the scope of collection and procurement

September 10, 2011 – The State Council Information Office held a series of press conferences on the theme of “promoting high-quality development” on the morning of the 10th, Yan Qinghui, deputy director of the State Medical Insurance Bureau, said at the meeting that the medical insurance sector will vigorously promote the expansion of the quality of the collection of medicine and mining. Continuously expand the coverage of collection, carry out a new batch of national organization drugs and high-value medical supplies collection, will be cochlear implants and other high-value medical supplies into the collection. Yan Qinghui introduced, the effectiveness of the collection work can be recognized from three aspects: First, the burden of drug use by the public has been reduced, and the accessibility and quality of drugs have been improved. For example, hepatitis B antiviral drugs entecavir and tenofovir, etc., the annual cost of patients before the ...
- Source: https://finance.eastmoney.com/a/202409103179908838.html
- 110
- September 11, 2024
Novo Nordisk applies for listing of growth hormone in China once a week

Today, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Screenshot source: CDE official website Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone ...
- Source: drugdu
- 111
- September 11, 2024
Plant intervention at the forefront, terminate IPO!

On September 4th, the Shanghai Stock Exchange terminated one IPO company: Shandong Branden Medical Equipment Co., Ltd. (hereinafter referred to as “Branden”). According to information, this was Branden’s voluntary withdrawal of its listing application, and the listing on the Science and Technology Innovation Board was terminated. Two major products support the banner of revenue Founded in 2003, Baibai An is a national high-tech enterprise dedicated to applying medical material modification technology to implantable medical devices, focusing on the research and development, production, and sales of biological and medical products. Through independent research and continuous innovation, Branden has formed a technology platform centered on medical material modification, precision machining, and digital diagnosis and treatment of vascular pathways. According to the prospectus, Branden is the first domestic enterprise to obtain the registration certificate for Class III medical device products of domestically produced Peripherally Inserted Central Catheters (PICCs), breaking the monopoly of imported ...
- Source: drugdu
- 112
- September 9, 2024
CPC releases the first miniature sterile connector suitable for low-temperature applications in the cell and gene therapy industry

On September 5, 2024, Colder Products Company (CPC) launched a new sterile micro connector, which is the first connector that can be directly loaded into a freezer and is used in cell and gene therapy (CGT) processes. The MicroCNX ® ULT series can be frozen to -190 ° C and is compatible with the most commonly used types of tubing for developing cutting-edge therapies, including polyvinyl chloride (PVC) tubing. In order to meet the needs of cell viability, shelf life, and transportation, many cell therapy processes are lowered to a temperature range of -150 º C or lower, “said Troy Ostreng, Senior Product Manager of CPC Biopharmaceutical Business. The MicroCNX ® ULT connector is designed to provide a simple and efficient method for achieving sterile connections in pipelines used for small cell therapy and gene therapy components. This connector does not require additional piping in the process, thus helping to ...
- Source: drugdu
- 92
- September 9, 2024

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