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Chiatai Tianqing’s Liraglutide Approved for Listing, Formally Entering the Field of Biological Drugs to Control Glucose

On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company’s liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing’s formal entry into the field of biopharmaceutical glycemic control. Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to ...
- Source: drugdu
- 87
- June 27, 2024
Fosun Pharma to Privatize Henlius for $5.407 Billion, Integrate Innovative Assets to Further Focus on Pharmaceutical Business

On June 24, 2024, Fosun Pharma (600196.SH; 02196.HK) announced that it intends to privatize its subsidiary, Henlius (02696.HK), through a merger by absorption. The cash consideration for this absorption and merger transaction is HK$24.6 per share, which is a premium of 36.67% to the closing price of Henlius H shares on the undisturbed date; and a premium of 52.04% to the 30 trading days prior to the undisturbed date. The aggregate cash consideration for the Merger by Absorption shall not exceed approximately HK$5,407 million or its equivalent in RMB. As a core innovative asset of Fosun Pharma, Fuhong Henlius, upon completion of the transaction, will contribute to the sustainable growth of Fuhong Henlius as well as strengthen Fosun Pharma’s strategic layout in the field of innovative biopharmaceuticals. Henlius, as an international innovative biopharmaceutical company, is committed to providing affordable and high-quality biopharmaceuticals to patients around the world, with products covering ...
- Source: drugdu
- 125
- June 27, 2024
UK dementia organisations publish new manifesto ahead of general election

Alzheimer’s Society, Dementia UK, Alzheimer’s Research UK, the UK Dementia Research Institute (UK DRI) and Alzheimer Scotland have collaborated to create a new manifesto for dementia, ahead of the 2024 general election (4 July). The new manifesto, ‘Dementia: a manifesto’, calls on the next UK government to make dementia a key health priority in the UK. Affecting 982,000 people in the UK, dementia is a term for the impaired ability to remember, think or make decisions in day-to-day life. There is currently no cure available and the care and treatment options that currently exist for patients living with the neurodegenerative disease are often disjointed, inaccessible and inadequate. The new manifestos call on the next UK government to better understand how to prevent, reduce and delay dementia; increase access to diagnosis and treatment; help people living with dementia navigate support groups; create a care system that works for everyone; and invest ...
- Source: drugdu
- 100
- June 27, 2024
Europe contributes over €750m to African Vaccines Manufacturing Accelerator

The EU, its Member States and European financial institutions have announced a more than €750m contribution to the newly launched African Vaccines Manufacturing Accelerator (AVMA) as part of the EU’s Global Gateway strategy. Over the next decade, the AVMA aims to purchase more than 800 million vaccine doses produced in Africa, making more than €1bn available to manufacturers to offset high start-up costs while providing assurance of demand. Developed by Gavi, the Vaccine Alliance and the Africa Centres for Disease Control and Prevention, the AVMA has the potential to improve African pandemics, outbreaks, preparedness and responses, as well as to support global health security. It aims to enhance the predictability of demand for vaccines made in Africa, support the growth of its manufacturing base and achieve its ambition to produce most vaccines required by African countries on the continent while also helping to diversify a set of global vaccine suppliers ...
- Source: drugdu
- 86
- June 27, 2024
Low-Cost CRISPR-Based Paper Strip Test to Improve Flu Diagnosis and Surveillance

Annually, less than 1% of people who contract the flu are tested, largely due to the need for skilled personnel and sophisticated equipment. Now, researchers have developed a low-cost paper strip test that could enable more individuals to determine the type of flu they have and receive appropriate treatment. This innovative test developed by researchers from the Broad Institute of MIT and Harvard (Cambridge, MA, USA) and Princeton University (Princeton, NJ, USA) employs CRISPR technology to differentiate between the primary seasonal flu types, influenza A and B, and the subtypes H1N1 and H3N2. It can also identify strains resistant to antiviral treatments and could potentially extend to detecting swine and avian flu strains, including H5N1, which currently affects cattle. This could enhance both outbreak response and clinical care by making accurate, affordable, and rapid testing accessible in doctors’ offices and laboratories across the world. The test is based on a ...
- Source: drugdu
- 123
- June 26, 2024
New Blood Test Enables Accurate Diagnosis of Dementia and Neurological Diseases

Frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and progressive supranuclear palsy (PSP) represent a group of neurodegenerative diseases with symptoms that include dementia, behavioral changes, paralysis, muscle wasting, and movement impairments. These diseases are rare but have severe health impacts, and currently, there are no cures. Presently, conclusive diagnosis of the molecular pathology of these diseases during a patient’s lifetime is challenging because it typically requires examination of brain tissue. However, accurate diagnosis is essential for developing therapies and for patient stratification, which is necessary for testing targeted disease-modifying treatments. Now, researchers have demonstrated that the most common forms of FTD, as well as ALS and PSP, can be detected through blood tests, though these tests are not yet ready for routine clinical use. In the long term, they could significantly improve disease diagnosis and accelerate the development of new treatments. This research, led by the German Center for Neurodegenerative ...
- Source: drugdu
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- June 26, 2024
CPHI & PMEC China

Organiser：Informa Markets Time：September 9th – 11th, 2024 address：Shenzhen Convention and Exhibition Center, Fuhua 3rd Road, Futian District, Shenzhen Exhibition hall：Shenzhen Futian Convention and Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs) and Intermediates, Biopharmaceuticals, Pharmaceuticals, Pharmaceutical Excipients, CDMO, Natural Extracts, Third-party Services, Pharmaceutical Machinery, API Equipment, Packaging Equipment, Cleanroom Equipment and Engineering, Laboratory Construction and Systems, etc. About CPHI & PMEC China： CPHI & PMEC China (Shenzhen) continues to focus on the pharmaceutical industry development in the Guangdong-Hong Kong-Macao Greater Bay Area, radiating the Asian market, and concentrating on the transformation and upgrading of new drug development, technological innovation, and other fields. It aims to create a more precise, professional, and technology-driven industrial upgrading platform, deeply connecting the industrial exchanges and cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area and even Asia.
- Source: drugdu
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- June 26, 2024
FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Don Tracy, Associate Editor Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older. The FDA has approved Harmony Biosciences’ Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy. The FDA based the approval on results from a Phase III study conducted by Bioprojet, which evaluated the safety and efficacy of the treatment in patients over 6 years of age. Additionally, Wakix is the first non-scheduled treatment to be approved for EDS in pediatric patients.1 “Following the FDA’s decision to grant priority review, we are very pleased with the Agency’s timely review and approval of Wakix for pediatric narcolepsy patients with excessive daytime sleepiness,” said Jeffrey M. Dayno, MD, president, CEO, Harmony Biosciences, in a press release. “EDS is the primary symptom experienced ...
- Source: drugdu
- 101
- June 26, 2024
FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. By Frank VinluanA blockbuster Argenx therapy now has an additional FDA approval as a treatment for a rare autoimmune disorder affecting nerves, marking the first new treatment for this condition in decades and a new blockbuster opportunity for this pipeline-in-a-product drug. The disease, chronic inflammatory demyelinating polyneuropathy, or CIDP, develops as the immune system attacks myelin, the protective covering of nerve fibers. CIDP leads to weakness and impairment of motor function, numbness and tingling, and difficulty walking. In many cases, the loss of muscle function requires patients to rely on a wheelchair for mobility. The FDA’s late Friday approval of the Argenx product, Vyvgart Hytrulo, covers the treatment of ...
- Source: drugdu
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- June 26, 2024
【EXPERT Q&A】Simaglutide API is exported to Thailand, which registration qualifications need to be met and the registration process for drug registration in Thailand (preparation manufacturers are local enterprises in Thailand)

Drugdu.com expert’s response: 1.Registration Qualification Requirements ①Pharmaceutical Business License: To export Semaglutide API to Thailand, it is first necessary to ensure that your enterprise possesses a Pharmaceutical Business License, which is the basic qualification for drug export. ②GMP Certification: GMP certification refers to the certification of a pharmaceutical production quality management system. For the export of Semaglutide API to Thailand, your enterprise must also obtain GMP certification to ensure the quality and safety of the product. ③Pharmaceutical Quality Management System Certification: In addition to the above two qualifications, pharmaceutical quality management system certification is also necessary. This will help guarantee the quality of product sales and service in the Thai market. ④Pharmaceutical Liability Insurance: To safeguard the rights and interests of consumers, your enterprise should also consider purchasing pharmaceutical liability insurance. 2.Thai Drug Registration Process (Assuming the Formulation Manufacturer is a Local Enterprise in Thailand) ①Submission of Registration Application: ...
- Source: drugdu
- 145
- June 26, 2024

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