Drugdu.com expert’s response: The handheld nebulizer used in medical devices differs significantly from a humidifier in multiple aspects, as detailed below: Ⅰ. Primary Functions and Purposes Handheld nebulizer: Primarily used for treating respiratory diseases such as asthma and bronchitis. It atomizes medication into tiny particles, allowing patients to inhale them directly into the respiratory tract for therapeutic effect. This device typically requires use under medical guidance and in conjunction with specific medications or solutions. Humidifier: Primarily functions to increase the humidity of indoor air, reducing discomfort caused by dryness. It generally uses purified water or filtered water and does not involve the atomization of medication. Humidifiers are widely used in homes, offices, and other settings to improve the indoor environment. Ⅱ. Atomized Particle Size Handheld nebulizer: Produces very small atomized particles, usually around 0.4 to 1 micrometer in size. This particle size makes the medication easier for the human body ...
Today, Amgen announced the positive results of its weight loss therapy MariTide in a 52-week clinical phase 2 study. Analysis shows that in obese or overweight people without type 2 diabetes, MariTide achieved an average weight loss of about 20% in week 52, and there was no weight loss plateau, indicating that patients may lose weight further after treatment for more than 52 weeks. While weight loss drug companies generally rose, Amgen once plummeted by more than 12.3% because although the efficacy of Amgen’s MariTide weight loss drug met Wall Street expectations, it had high side effects and failed to beat Eli Lilly’s blockbuster drug Zepbound, and the trial results were lower than Wall Street’s high expectations for MariTide. In a one-year trial, non-diabetic patients took Amgen’s MariTide once a month or less frequently and lost up to 20% of their weight. Wegovy’s late-stage study showed a 15% weight loss ...
On November 25, Cassava Sciences announced that the Phase III ReThink-ALZ study of Simufilam for the treatment of mild to moderate Alzheimer’s disease (AD) did not meet the pre-specified dual primary endpoints, secondary endpoints, and exploratory biomarker endpoints. Compared with the placebo group, there was no obvious improvement trend in the ADAS-COG12 and ADCS-ADL scale scores of patients in the trial group. Among them, the test results obtained by the ADCS-ADL scale showed that the situation in the trial group was even worse than that in the placebo group. After the news of the failure of the Phase III study leaked, Cassava’s stock price plummeted 85% to US$3.91, while the previous closing price was US$26.48. Since the beginning of 2021, Simufilam’s ability to reduce the toxic effects of β-amyloid protein has been questioned. Two neuroscientists, Geoffrey Pitt and David Bredt, filed a petition with the U.S. Food and Drug Administration ...
AtriCure, a leading company in the treatment of atrial fibrillation, announced today that its EnCompass cardiac tissue ablation clip has received the EU CE mark, meaning the device can be sold in more than 30 countries in the European Economic Area (EEA). A number of innovative products were launched AtriCure was founded in 2000 and focuses on cardiac surgery solutions. The company mainly produces and sells cardiac ablation devices, providing innovative technologies for the treatment of atrial fibrillation and related diseases. At present, AtriCure has 138 authorized patents in the United States and has served more than 300,000 patients with atrial fibrillation since 2004. It is understood that the EnCompass cardiac tissue ablation clamp is used for cardiac tissue ablation surgery, including comprehensive epicardial ablation of the left atrium during open heart surgery. This is a simpler and faster method of open-chest cardiac ablation, allowing doctors to perform comprehensive epicardial ...
The layout of bispecific antibodies in the field of tumors has become mature, but in the field of autoimmune diseases, the layout of bispecific antibodies is relatively small. The first batch of enlightened MNCs have begun to take action. Recently, autoimmune bispecific antibody therapy has increasingly become the focus of new drug research and development. Many pharmaceutical giants such as Johnson & Johnson, Sanofi, and Roche have chosen to deploy in the field of autoimmune bispecific antibodies, with a total of more than US$8.15 billion (approximately RMB 59.1 billion) in mergers and acquisitions and related drug transactions. The track of autoimmune bispecific antibody therapy has changed. Sanofi, Merck, and Roche: Grabbing the beachhead of CD3 bispecific antibodiesCD3 is closely related to the activation of T cells. By combining CD3 and tumor-associated antigens, it can guide and activate T cells to approach and kill tumor cells. At present, most of the ...
On the evening of November 25th, Dezhan Health announced that the largest shareholder of the company, Shanghai Yueye Equity Investment Management Partnership Enterprise (Limited Partnership) (hereinafter referred to as “Shanghai Yueye”), has recently been ruled by the Shanghai Third Intermediate People’s Court to confirm its liquidation plan. All shares held by Shanghai Yueye in the company will be liquidated and disposed of through public auction. According to the data, Shanghai Yueye holds 414 million shares of the company’s unrestricted tradable shares, accounting for 19.13% of the company’s total share capital and 19.37% of the total share capital after excluding the number of shares in the company’s repurchase special account. There is no pledge or freezing of the shares it holds. The announcement states that the auction matters involved in this liquidation plan have not yet officially begun to be implemented. The specific arrangements and related requirements for public auctions shall ...
Due to some chronic and common diseases, patients come to township health centers and community health service centers for treatment, but are told that ‘there is no medicine’. In response to the problem of difficult medication at the grassroots level, the National Health Commission and six other departments recently jointly issued the “Opinions on Reforming and Improving the Grassroots Drug Linkage Management Mechanism to Expand the Types of Grassroots Drugs”, striving to smooth the channels for drug connection between urban and rural areas, counties and townships, enhance the ability of grassroots drug allocation and use, and meet the basic medication needs of the masses. Expand types Make the medicine at the doorstep more comprehensive The proportion of grassroots diagnosis and treatment in China has reached 52% by 2023. However, some medical staff have previously reported that there are few types of drugs available at the grassroots level, limited space for ...
More than 300 years ago, British architect and scientist Sir Christopher Wren became interested in drug delivery, hoping to find a way to directly inject drugs or liquids into the human body. He made a simple syringe using tools such as goose feathers and metal tubes, and for the first time attempted to inject drug solution into a dog’s veins through injection. Since then, “injection” has gradually become a widely used method of drug delivery. Today, many large molecule biologics, such as recombinant insulin, monoclonal antibodies, and vaccines, are mainly injected into the human body to exert their therapeutic effects. However, the pain and trouble caused by injection are self-evident, especially when treating chronic diseases such as diabetes or cancer that require frequent medication, injection has brought considerable burden to patients’ daily life. So, in recent years, many scientists have been actively seeking innovative methods for drug delivery systems: without ...
1. Jimu Biological License: Tian Tian Pharmaceutical ARVN001 600 million yuan On November 13th, Tian Shan Pharmaceutical and Ji Mu Biotechnology announced that Ji Mu Biotechnology has authorized Tian Shan Pharmaceutical with exclusive commercial rights for its ARVN001 (Triamcinolone Acetonide Choroidal Injection Suspension) under development in mainland China. ARVN001 uses a suprachoroidal microinjection (SCS microinjection) system ®) The patented technology will be used to treat uveitis related macular edema (UME) and other potential ophthalmic indications under development. Jimu Biotech will receive a total down payment and milestone payments of up to 85 million US dollars (approximately 600 million RMB). Previously, Jimu Biotechnology obtained the rights to develop and commercialize this therapy in the Asia Pacific region from Clearside Biomedical Inc. In July 2024, Jimu Biotechnology announced that ARVN001 achieved positive top line results in the Phase III clinical trial of UME in China. Meanwhile, research on the use of this ...
On November 20, local time, Jazz Pharmaceuticals announced that the U.S. FDA has accelerated the approval of its HER2-targeted bispecific antibody Zanidatamab (Ziihera), developed in collaboration with Zymeworks, for marketing for the treatment of patients with previously treated, unresectable, locally advanced or metastatic HER2-positive biliary tract cancer. The press release pointed out that this is the first and only HER2 bispecific antibody approved by the FDA for HER2+ biliary tract cancer. Zanidatamab (ZW25) is a bispecific antibody based on the Zymeworks Azymetric platform that can simultaneously bind to two non-overlapping HER2 epitopes, i.e., biparatopic binding. This unique design can form multiple mechanisms of action, including dual blocking of HER2 signals, enhanced binding and removal of HER2 proteins on the cell surface, and strong antibody effector functions to enhance anti-tumor activity in patients. Previously, Zenidatumomab has been granted breakthrough therapy designation, fast track qualification, priority review qualification, orphan drug qualification, etc. ...
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