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【EXPERT Q&A】How to handle the medical device network sales record certificate?

Drugdu.com expert’s response: To apply for the certificate of record-filing for online sales of medical devices, the following steps are typically involved: Preparation of Qualifications: Firstly, the medical device online sales enterprise needs to ensure compliance with relevant regulations and requirements, including business licenses, medical device operation permits, etc. Application for Record-filing: Submit the record-filing application to the relevant regulatory authority, which is usually the National Medical Products Administration (NMPA) or local drug regulatory department. The application needs to include basic information about the enterprise, information about the sales platform, types and quantities of medical devices sold, and other relevant information. Record-filing Review: The regulatory authority will review the record-filing application. The review process typically includes assessing whether the sales platform meets requirements and whether the medical devices sold comply with regulatory standards. Issuance of Certificate: If the record-filing application passes the review, the regulatory authority will issue the certificate ...
- Source: drugdu
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- April 16, 2024
InterPharma 2024

Organiser: JI EXPO Time:9 – 12 Oct 2024 address：Jl. Gatot Subroto, RT.1/RW.3, Gelora, Tanahabang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270,Indonesia Exhibition hall: Balai Sidang Jakarta Convention Center Product range: Apis, intermediates, natural extracts, excipients, formulations, custom manufacturing, biopharmaceuticals, fine chemicals, laboratory equipment, instruments, laboratory appliances, water treatment, environmental and quality control, technical publications, pharmaceutical products, pharmaceuticals, pharmaceutical engineering, materials and packaging, pharmaceutical machinery and equipment About InterPharma： Jakarta Pharmaceutical Exhibition (InterPharma) is the largest and most influential pharmaceutical exhibition in Indonesia. It is one of the important pharmaceutical, pharmaceutical and packaging professional exhibitions in Southeast Asia. It can exhibit the range of apis, intermediates, biopharmaceuticals, medical supplies, material packaging, pharmaceutical machinery and equipment, etc. At the same time, various conferences will be held to discuss the future development trend of the pharmaceutical industry, and the market potential is huge.
- Source: drugdu
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- April 16, 2024
Enrollment of Subjects in Phase III Clinical Trial for Inhaled Aerosol Drug in Children by Kexing Biopharm

SHENZHEN, China, April 10, 2024 /PRNewswire/ — Recently, Kexing Biopharm (688136.SH) announced that the Phase III clinical trial of Human Interferon α1b Inhalation Solution developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., had completed the enrollment of first patient and dosing. This drug is indicated for respiratory syncytial virus-associated lower respiratory infections (pneumonia, bronchiolitis) in children. It is designed specifically for children by using a nebulizer, which can directly deliver the active ingredients to the lesion site, resulting in a rapid onset of therapeutic effect, improved pediatric patient compliance and safety. As mentioned by relevant R&D directors of Kexing Biopharm, the Phase I clinical dose-escalation and bronchoalveolar lavage studies of Kexing Biopharm’s Human Interferon α1b Inhalation Solution were completed in October 2023. In these studies, the drug safety, tolerability and concentration in the lungs were systematically and comprehensively validated. The results showed high local drug concentration in the ...
- Source: drugdu
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- April 15, 2024
Sinovac Biotech Ltd.’s 5-dose Sabin Strain Inactivated Polio Vaccine Approved for Global Polio Eradication Efforts

On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as “sIPV”) received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as “polio”), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech ...
- Source: drugdu
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- April 15, 2024
GlobalData

The pharma industry has experienced a notable uptick in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology over the past five years. These agreements, primarily concentrated in oncology, immunology, and central nervous system therapeutics, have collectively accumulated an impressive $21 billion in deal value. Furthermore, the period from 2020 to 2022 witnessed a remarkable surge in deal worth, particularly in the domain of hematological disorders, reaching a substantial total deal value of $1.8 billion, reveals GlobalData. Ophelia Chan, Business Fundamentals Analyst at GlobalData, comments: “This underscores the increasing significance of CRISPR advancements in the development of therapies for hematological disorders.” The FDA’s approval of Casgevy in December 2023 marked a significant breakthrough in gene therapy. Developed jointly by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first CRISPR and CRISPR-associated protein 9 (Cas9) genome editing therapy for sickle cell disease and beta thalassemia. This ...
- Source: drugdu
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- April 15, 2024
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe

Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent ...
- Source: drugdu
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- April 15, 2024
Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies

Don Tracy, Associate Editor Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts. Invenra Inc. and Astellas Pharma announced that they have agreed to terms on a collaboration that seeks to utilize Invenra’s B-Body bispecific antibody platform to bolster Astellas’ research and development efforts in bispecific therapeutic research. Per the agreement, Astellas will acquire full access to the B-Body platform, with the opportunity for further license negations upon the completion of this initiative. Both teams stated that they remain dedicated to pushing the boundaries of healthcare through innovative research, with the ultimate goal of providing new, effective treatments to patients worldwide.1 “We are honored to partner with the Astellas team, one of the world’s foremost developers of therapeutics,” said Roland Green, PhD, CEO, Invenra, in a press release. “We are excited by the potential of this partnership to yield profound benefits to ...
- Source: drugdu
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- April 15, 2024
Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
- Source: drugdu
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- April 15, 2024
MMI receives de novo nod for microsurgery robot

Dive Brief Medical Microinstruments (MMI) has received de novo authorization for a robotic system that enables surgeons to reconnect tiny blood vessels, the company said Monday. The Food and Drug Administration authorized the device, called the Symani Surgical System, for soft tissue manipulation to perform microsurgery, a way to restore blood flow and redirect fluid during reconstruction or repair. CEO Mark Toland said the commercial availability of Symani could increase the number of physicians who can perform complicated microsurgical procedures. MMI plans to immediately launch the system in the U.S. Dive Insight Microsurgery and supermicrosurgery, a technique for 0.3mm to 0.8mm vessels, are microscope-assisted operations that enable physicians to take a piece of tissue from one part of the body and use it to reconstruct another area. By reconnecting blood vessels, surgeons can restore form and function to parts of the body damaged by trauma or disease. The potential for ...
- Source: drugdu
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- April 15, 2024
Study provides valuable insights into the DCB-only strategy for left main coronary artery disease

Sanna Uskela et al., at North Karelia Central Hospital-Heart Center, Finland, conducted a retrospective single-center registry study that focused on the use of drug-coated balloon (DCB)-only strategy for treating de novo left main coronary artery disease. This study is significant as it addresses a treatment approach that has not been extensively studied before, particularly in the context of high bleeding risk (HBR) patients. The study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using the DCB-only strategy between August 2011 and December 2018. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups based on whether the lesion preparation was done according to the international consensus group guidelines. Key findings from the study include: (1) The study included 66 patients with a ...
- Source: drugdu
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- April 15, 2024

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