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Latest! “4 innovative medical devices” approved for marketing

Recently, the National Medical Products Administration approved the registration applications for four innovative products: “Intestinal Polyp Electronic Lower Gastrointestinal Endoscopy Image-Assisted Detection Software” by Changsha Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as Changsha Huiwei Intelligent), “Rotational Ablative Treatment Device” and “Disposable Coronary Ablative Catheter” by Shanghai Microport Melody Medical Technology Co., Ltd. (hereinafter referred to as Microport Melody), and “Disposable Magnetic Electric Positioning Pressure Monitoring Pulsed Electric Field Ablation Catheter” by Hunan Apt Medical Devices Co., Ltd. (hereinafter referred to as Apt Medical). Another product ofChangsha Huiwei Intelligent has been approved Changsha Huiwei Intelligence was established in 2020 and is a wholly-owned subsidiary of Suzhou Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as Huiwei Intelligence). Huiwei Intelligence was established in June 2019 and specializes in the research and development, production and sales of intelligent medical products. Driven by its independent core technologies in the fields ...
- Source: drugdu
- 66
- December 25, 2024
Everest Medicines/Pfizer’s “autoimmune new drug” is listed in China

On December 17, according to the official website of CDE, Genting New Energy’s application for marketing approval of the Class 5.1 imported chemical drug “Itramod Tablets” was accepted for the treatment of moderate to severe active ulcerative colitis. According to public information, Itramod tablets were originally developed by Arena. Pfizer acquired the company in 2022 and included the drug in its pipeline. Billion-dollar sales prospects target the “million-patient market” Inflammatory bowel disease (IBD) is a type of disease that causes inflammation of the digestive system, and the number of patients worldwide is on the rise. IBD mainly includes ulcerative colitis and Crohn’s disease, of which ulcerative colitis is common in patients aged 20 to 30 years old, and clinical manifestations include persistent or recurrent diarrhea, mucus, pus and blood in the stool with abdominal pain, and even skin lesions and mucosal lesions. At present, the cause of the disease has ...
- Source: drugdu
- 64
- December 25, 2024
【EXPERT Q&A】Do fascia guns need to be certified as medical devices in Japan?

Drugdu.com expert’s response: Whether a fascia gun needs to undergo medical device certification in Japan mainly depends on its market positioning and product category. I. Market Positioning of Fascia Guns in Japan There are two different product definitions for fascia guns in the Japanese market: Ordinary Household Products: If fascia guns are exported to Japan as ordinary household products, they are not required to undergo mandatory medical device certification and can be sold directly in the Japanese market. Medical Devices: If fascia guns are defined as medical devices and exported to Japan, they will need to undergo medical device certification. In this case, the product’s added value may increase and it may become more favored by the Japanese market. According to the regulations of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, fascia guns classified as medical devices fall under “designated controlled” products. II. Certification Process for Medical Devices ...
- Source: drugdu
- 160
- December 25, 2024
Taking advantage of the “Eight Measures of Science and Technology”, Haier Health aims to create a flagship of biotechnology

Query the real-time market situation of the stock, uncover in-depth data on fund flow, and enter Shanghai Laishi Bar. Shanghai Laishi Fund Flow Related Stocks Yongshun Biotechnology (0.000%) Ternary Gene (0.000%) Kangle Defender (0.000%) Oukang Pharmaceutical (0.000%) Related sections Biological products (0.00%) Standard&Poor’s (0.00%) FTSE Russell (0.00%) In vitro diagnostics (0.00%) The first step in stock trading is to open a stock account On the evening of December 22nd, Qingdao Haier Biomedical Co., Ltd. (“Haier Biotech”, 688139. SH) issued a suspension notice regarding the planning of a major asset restructuring. According to the announcement, Haier Biology and Shanghai Laishi Blood Products Co., Ltd. (“Shanghai Laishi”, 002252. SZ) are both listed companies controlled by Haier Group. The two parties have signed an “Absorption and Merger Intention Agreement”, in which Haier Biology will absorb and merge Shanghai Laishi by issuing A-shares to all shareholders of Shanghai Laishi, and raise matching funds through ...
- Source: drugdu
- 159
- December 24, 2024
Beware of “two sets of prices” providing funding sources for pharmaceutical bribery

On December 20th, the National Medical Insurance Bureau sent a letter to the medical insurance bureaus of various provinces, autonomous regions, municipalities directly under the central government, and Xinjiang Production and Construction Corps in response to the investigation of the false invoicing case in the pharmaceutical field by the public security department, requesting a serious investigation into whether there were similar problems with the products involved, such as Ginkgo biloba extract injection, Cefotaxime sodium injection, hydrolyzed protein oral solution, etc., and to quickly determine the bottom line of the listed prices. The National Healthcare Security Administration stated in the letter that it firmly opposes the increase in patient burden caused by inflated drug prices, the formation of illegal profit chains through false invoicing, and illegal and irregular behaviors such as “double pricing of one drug” and “selling with money”. (December 22, People’s Daily Online) Recently, the Economic Reference Daily reported ...
- Source: drugdu
- 207
- December 24, 2024
Is placebo effective? Vertex evaporates $13 billion overnight

On December 19, 2024, Vertex announced that its non opioid painkiller suzetrigine (VX-548) had achieved the primary endpoint of significantly reducing pain in the Phase 2 Sciatica (LSR) study. However, the placebo group also showed significant pain relief (about 2 points), and the difference between the treatment group and the placebo group was not significant. Affected by this news, Vertex’s stock price plummeted by 11.37%. 01. Background VX-548 is a selective NaV1.8 pain signal inhibitor under development, aimed at blocking the transmission of pain signals to the brain by specifically blocking sodium channels in peripheral nerves. Due to its mechanism of action being limited to the peripheral nervous system, VX-548 does not pose an addiction risk to opioid drugs. Previously (December 2023), Vertex retrieved phase 2 clinical data on VX-548 for chronic pain, which showed that its efficacy was comparable to that of the control group Pregabalin. This study further ...
- Source: drugdu
- 163
- December 24, 2024
Aadi Biosciences and WuXi Biologics collaborate to develop 3 new ADC drugs

On December 20, 2024, WuXi Biologics announced that Nasdaq listed biotechnology company Aadi Biosciences had reached a cooperation agreement with WuXi Biologics and Duoxi Biologics to jointly develop three new generation ADC drugs in the preclinical stage, using WuXi Biologics’ antibody discovery technology platform and Duoxi Biologics’ linker payload technology. Aadi Biosciences paid a prepayment of $44 million, a development milestone of $265 million, a commercial milestone of $540 million, and a single digit sales share to WuXi Biologics and Duoxi Biologics, with a total agreement amount of $849 million. Affected by this news, the stock price of Aadi Biosciences surged 63% after trading. Aadi Biosciences had long focused on drug development in the mTOR pathway. Aadi Biosciences’ sirolimus albumin received FDA approval for marketing in 2021, with cumulative sales of $45 million in the first half of this year. As of the end of June this year, Aadi Biosciences ...
- Source: drugdu
- 98
- December 24, 2024
Novo Nordisk’s talent war

Novo Nordisk’s success has not only driven Denmark’s economic growth, but also led to an increasingly fierce talent war in the local labor market. As of September this year, the company employed about 32,000 employees across Denmark, and the number of employees has increased by 75% in less than three years. How exaggerated is Novo Nordisk’s talent war? Because Novo Nordisk offers higher salaries and more attractive career opportunities, many small businesses are forced to close or relocate because they cannot compete with it. For example, Flint Auto, a car service shop in Kalundborg, was forced to close because employees jumped to Novo Nordisk. Construction-related industries are facing a loss of talent, and many companies have to refuse orders due to lack of employees. The clinical microbiology department of a local hospital lost about 10 employees to Novo Nordisk in two years, and it was difficult to recruit new people. ...
- Source: drugdu
- 77
- December 24, 2024
The result exceeded expectations, but AstraZeneca’s “life-saving drug” was still rejected by the FDA

Recently, AstraZeneca announced that the FDA rejected the full approval of its drug Andexxa. It is worth mentioning that the drug was applied for listing in China in December last year. In 2018, Andexxa was approved by the FDA for accelerated listing in the United States, and the following year it won conditional approval from the European Union for the treatment of acute bleeding complications caused by apixaban and rivaroxaban. It is the first and only treatment method that can specifically reverse the activity of FXa inhibitors and achieve hemostasis. It can be said to be a “life-saving drug” in clinical practice. In 2021, AstraZeneca acquired the rare disease giant Alexion for US$39 billion, and Andexxa became a drug under AstraZeneca. Last year, Andexxa contributed US$182 million in sales to AstraZeneca, a year-on-year increase of 23%. In its reply letter, the FDA pointed out that the rejection was because the ...
- Source: drugdu
- 75
- December 24, 2024
AD market is worth hundreds of billions. Can Eli Lilly catch up?

On December 18, Eli Lilly announced that the application for the listing of Donanemab injection (Donanemab) has been approved by the China National Medical Products Administration for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer’s disease in adults. This is another blockbuster new drug in the field of Alzheimer’s disease (AD) treatment after Lencanerizumab, which was approved by Eisai in January this year. In the past, drugs for the treatment of AD were mainly symptomatic treatments, including memantine, donepezil, etc., which symptomatically treated mild, moderate and severe AD. Lencanerizumab and Donanemab, which were launched this year, are targeted treatments for causes. ▍Crossing the Death Valley of Drug Development The research on new drugs for Alzheimer’s disease has always been called the “Death Valley” of drug development. According to a study published by Scientific American magazine, the development of new AD drugs has a high failure rate ...
- Source: drugdu
- 91
- December 24, 2024

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