Search Results for “EU” – Page 13 – media

Hengrui Pharmaceuticals’ Innovative Drug HRS-9813 Tablets for Treatment of Idiopathic Pulmonary Fibrosis Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals’ subsidiary Guangdong Hengrui Pharmaceuticals Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-9813 tablets, a Class 1 new drug, to carry out clinical trials for idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrotic interstitial lung disease of unknown cause, which ultimately leads to hypoxemia, respiratory failure and even death.IPF was included in the first batch of China’s rare disease catalog in 2018, and in recent years, studies have shown that its incidence and prevalence are on the rise globally, and its prognosis is poor, and it is one of the diseases that researchers are currently working to overcome. Currently, there are limited drugs approved for the treatment of IPF at home and abroad, and there are still deficiencies in terms of safety and patient compliance.There is still a huge unmet ...
- Source: drugdu
- 105
- July 8, 2024
The Need for Contextualization and Cloud-based Integration

Data exchange lies at the heart of innovation. With the right data available, BioPharma companies can best implement advanced analytics tools for timely interventions in manufacturing deficiencies and optimize processes. By Harlan KnappBuilt-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the importance of the accuracy and reliability of data across supply chains. Yet, the difficulty of achieving this milestone can still be underestimated by drug sponsors, especially when working with manufacturing partners. Although organizations are expected to demonstrate full governance of their data across the product lifecycle, their access to process data remains limited, which hinders early risk detection as well as the scalability of manufacturing. With agile manufacturing networks, novel therapeutic modalities such as mRNA vaccines and cell and gene therapies, the single-source manufacturing model using on-premise/siloed infrastructure can have an adverse ...
- Source: drugdu
- 126
- July 6, 2024
Hengrui Pharmaceuticals Bupivacaine Liposome Injection Approved for Marketing in the United States

Today, Hengrui Pharmaceuticals Bupivacaine Liposome Injection was successfully approved for listing in the United States. This product is the first generic drug of this species approved for marketing in the world, and its listing in the U.S. is an important milestone in the international development of the company’s high-end preparations. Bupivacaine liposome injection was first approved in the United States in 2011, and the original product is currently sold only in the United States and Europe, and has not been imported domestically. Because of its high technical barriers, no generic product has been successfully listed for more than 10 years. Hengrui Pharmaceuticals Bupivacaine Liposome Injection has been approved to be listed in China at the end of 2022, which is the exclusive global first generic of Hengrui Pharmaceuticals’ Class 3 new drug, deemed to have passed the consistency evaluation, and is also the first ultra-long-acting local anesthesia drug in China, ...
- Source: drugdu
- 138
- July 4, 2024
The Financial Potential of Convertible Notes in the Pharmaceutical Sector

These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. By Jaylon M. ReynoldsIn the realm of biotech and pharmaceuticals, fundraising often plays a pivotal role in driving innovation and progress. Biotech and pharmaceutical companies, whether private startups or established public firms, frequently turn to convertible notes as a strategic financial instrument. These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. Convertible notes are utilized, structured, valued, and accounted for in various ways within the context of the biotech and pharmaceutical industries. Private companies For burgeoning private biotech and pharmaceutical firms, navigating the journey from research and development to commercialization can be financially demanding. Convertible notes offer a flexible financing solution, providing companies with the necessary capital to fuel their operations ...
- Source: drugdu
- 69
- July 1, 2024
TOFIDENCE (BAT1806/BIIB800), a biosimilar developed by BIO-THERA with reference to Amero® (tolizumab), received marketing approval from the European Commission.

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is focused on developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company’s partner, Bojian (NASDAQ: BIIB), recently received notification from the European Commission that it has granted marketing approval to BIO-THERA for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and other diseases. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in April 2024 for the treatment of moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. The European Commission’s approval of the marketing application for TOFIDENCE (BAT1806/BIIB800) ...
- Source: drugdu
- 67
- June 28, 2024
【EXPERT Q&A】Is it easy to apply for the EU CE certification?

Drugdu.com expert’s response: CE certification is a certification system established by the European Union to ensure the safety of products for people, animals, and objects. For companies that want to export their products to EU member states, CE certification is essential. From a process perspective, CE certification is not complicated, mainly including filling out an application form, providing product information, sending samples for testing, and obtaining a certificate or report after passing the test. The entire process is usually completed within 5-7 working days. Therefore, from an operational level, CE certification is relatively easy to apply for. However, it should be noted that the preparation of technical documents involved in CE certification is relatively cumbersome, including but not limited to the product name, model, instruction manual, safety design documents, technical conditions, electrical schematics, etc. Enterprises need to ensure that these documents are complete, accurate, and comply with relevant EU standards.
- Source: drugdu
- 99
- June 28, 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
- 128
- 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
- 87
- June 27, 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
- 180
- June 26, 2024
Researchers reveal genetic makeup could identify treatment options for sepsis

Researchers from the Wellcome Sanger Institute, the University of Oxford and collaborators have revealed that genetic makeup could help determine the best treatment options for sepsis patients. Published in Cell Genomics, findings from the study could potentially lead to the development of targeted therapies to treat the condition. Responsible for 11 million deaths globally every year, sepsis is a serious condition in which the body responds improperly to an infection, causing the organs to work poorly. Depending on patients’ immune responses, which can be difficult to identify based on symptoms alone, treatment for sepsis can vary. Built on previous studies that identified different subgroups of patients with sepsis, researchers analysed data from the UK Genomic Advances in Sepsis study, involving 1,400 sepsis patients due to community-acquired pneumonia and faecal peritonitis, to investigate the impact of genetic variants that regulate expression quantitative trait locus (eQTLs), a type of gene expression. After ...
- Source: drugdu
- 88
- June 25, 2024

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