Search Results for “biosimilar ” – Page 8 – media

US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 68
- August 15, 2024
Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU. The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University. HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, ...
- Source: drugdu
- 98
- August 12, 2024
Avzivi® (BAT1706) receives marketing approval from 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 dedicated to the development of 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 recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 81
- August 1, 2024
【EXPERT Q&A】What are the dilemmas facing the pharmaceutical industry?

Drugdu.com expert’s response: The pharmaceutical industry faces numerous challenges, including: Ⅰ.High R&D Costs: Drug development is a lengthy and expensive process, often requiring billions of dollars and many years. The risk of failure is high, with many drugs not passing clinical trials. Ⅱ.Regulatory Pressure: Drug regulatory agencies (e.g., FDA, EMA) have increasingly stringent approval requirements for new drugs, necessitating more resources for clinical trials and data collection, thus increasing the difficulty and cost of bringing new drugs to market. Ⅲ.Short Patent Protection Period: The patent protection period for new drugs is relatively short. Once the patent expires, generic drugs quickly enter the market, significantly reducing the market share and profits of the original drug. Ⅳ.Intense Market Competition: The pharmaceutical market is highly competitive, not only from other innovative drugs but also from generic drugs and biosimilars. Ⅴ.Price Pressure: Governments and the public are increasingly concerned about drug prices, especially high-priced ...
- Source: drugdu
- 103
- July 24, 2024
Interphex Japan

Organiser：Reed Exhibitions Time：July 9-11, 2025 address： 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: Biomaterials: Amplification Equipment, DNA Extraction Equipment, Proteome Extraction & Purification, DNA Analysis Equipment, Proteome Analysis Equipment, Nuclear Magnetic Resonance, Automated Workstations, Automatic Dispensers, Cell Analysis Equipment, Incubators, Refrigerators, Nutrient Media, Mixers, Pipettes, Assay Kits, Regenerative Medicine, Drug Development, Biomaterials, Biocontracting, Pharmaceutical Intermediates, Cosmetic Ingredients, Fine Chemicals, Additives, Excipients, Plant Extracts Instrumentation: Analytical Instruments, Laboratory Equipment & Accessories, Chemical Reagents Bioengineering: Bioprocesses, Biochemistry, Biotechnology & Products, Analytical Methods, Nanobiotechnology & Products; Optics & Technologies Bioinformatics & Services: Bioinformatics, Biotechnology Services Medical & Pharmaceutical Applications: Medicine & Pharmaceuticals, Biologics, Biosimilars, & Biobetters Environmental Applications: Environmental Biotechnology, Agricultural Applications, Agricultural Products/Plant Biotechnology, Animal Husbandry Pharmaceutical Excipients: Pharmaceutical Packaging Materials, Pharmaceutical Excipients, Pharmaceutical Adjuvants & Equipment; Excipients (Antimicrobial Preservatives, Antioxidants, Capsules/Encapsulation, Coating Agents, Colors & Dispersions, Drug Delivery Systems, Emulsifiers/Solvents, Flavors & Fragrances, ...
- Source: drugdu
- 112
- July 19, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 98
- July 16, 2024
Publication in Journal of Translational Medicine Highlighting Henlius’ Dual HER2 Blockade Therapy Mechanism of Action

Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
- Source: drugdu
- 86
- July 15, 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
BIO-THERA Receives Positive CHMP Opinion for Bevacizumab Avzivi® in Europe

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 committed to 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 today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer. The CHMP’s opinion on ...
- Source: drugdu
- 63
- June 5, 2024
The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA

Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as ...
- Source: drugdu
- 113
- May 24, 2024

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