Before you complete FDA forms for your 510k submission, you need to made sure you have the most updated FDA forms. How do you know if the FDA form you are using is current? The FDA assigns numbers to each FDA form and the document control number is found in the bottom left footer of […]

The post How to find updated FDA forms for a 510k appeared first on Medical Device Academy.

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in January 2022. These updates are presented by China Med Device, LLC, your partner […]

The post NMPA Roundup January 2022 appeared first on China Med Device.

Cybersecurity employers need to adapt their recruitment and retention practices to gain from benefits and minimize detriments

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HONG KONG, Feb 7, 2022 - (ACN Newswire) - SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 21 January 2022, an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration of China (the "NMPA"). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of multiple sclerosis.

SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "after the Company announced earlier the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03, an IND application (for multiple sclerosis) for SN1011 has been filed with and accepted by the Center for the CDE of the NMPA, which will accelerate the progression of the Phase II clinical study and clinical development program related to indication for treatment of multiple sclerosis, fully reflecting the Company's efficient implementation of new drug R&D programs. We are absolutely confident in the enormous prospects of SN1011's clinical development. In the future, the Company will accelerate the program to further expand its product pipeline and strive to bring benefits to patients."

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.



Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 21 January 2022,

Buyers and sellers set the price of a product, not the market. Lack of expertise in consumer identification and verification

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Everything we covered on WTR over the past seven days – and all you need to know from the world of trademarks to set yourself up for the start of another busy week.

Company adds experienced clinical development expert to its board of directors OSLO, Norway–(BUSINESS WIRE)–Oncoinvent AS announces that Adrian Senderowicz was elected as a Non-executive Director today at the Company’s Extraordinary General Meeting. Adrian Senderowicz is a US Board certified medical oncologist, and President of Oncology Drug Development, LLC. Adrian is a highly experienced and talented […]

The post Oncoinvent appoints Adrian Senderowicz MD to its Board of Directors appeared first on Fintech News.

Do Psychedelics Help To Treat Pain?

Psychedelics works well for psychological disorders. But what about for ailments of the body? What about pain?

The post Do Psychedelics Help To Treat Pain? appeared first on The Fresh Toast.

An article by Scientific American, which was published last year, discusses how medical professionals are engaging in the studies to learn more. “Pain is this four-letter word that can mean so many different things,” says Stanford University School of Medicine assistant professor of anesthesiology, perioperative and pain medicine, Vivianne Tawfik. “There’s a role for opioids,” she tells Scientific American. “There might end up being a prescribed role for psychedelics. The jury’s still out.”

In this post we revisit the IP Updates ie., any amendments, ordinances, notifications, and other information related to IP published in the year 2021. For reader’s convenience it has been divided into parts, please find the link to the previous and next parts towards the end of this post. COPYRIGHT, INFORMATION TECHNOLOGY AND ECOMMERCE GOVT. NOTIFICATIONS-2021 The Ministry of Commerce and Industry has issued a notification, through the Department for Promotion of Industry and Internal Trade (DPIIT), introducing the Copyright (Amendment)…

The post Recap 2021: IP Updates – Part 2 appeared first on BananaIP Counsels.

In this post we revisit the IP Updates ie., any amendments, ordinances, notifications, and other information related to IP published in the year 2021. For reader’s convenience it has been divided into parts, please find the link to the next part towards the end of this post. THE INFORMATION TECHNOLOGY (INTERMEDIARY GUIDELINES AND DIGITAL MEDIA ETHICS CODE) RULES, 2021- A BRIEF NOTE The Government of India through the Ministry of Electronics and Information Technology (MietY) has recently issued a notification,…

The post Recap 2021: IP Updates – Part 1 appeared first on BananaIP Counsels.

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