Search Results for “biosimilar ” – Page 9 – media

EmpiRx Announces New AI-Powered Platform as Part of Push to Change PBMs

Mike Hollan The platform will use AI technology to provide pharmacists with more tools. The relationship between the pharma industry, pharmacists, and customers continues to evolve. EmpiRx Health, a PBM company headquartered in NJ, announced that it is launching a new AI-powered platform.1 The new platform is called Clinically, and it will use AI technology to help pharmacists with claims adjudication, clinical reviews, and other features that EmpiRx says will put the pharmacists at the center of the PBM model. In a press release, EmpiRx’s CEO Danny Sanchez said, “Our new Clinically platform clearly demonstrates EmpiRx Health’s strong commitment to transforming the pharmacy care industry by creating the PBM of the future – one that’s already providing the highest quality service to customers, patients, and advisor partners. This PBM revolution was long overdue. Far from helping plan sponsors to manage and lower drug costs, the traditional PBM model, which prioritizes ...
- Source: drugdu
- 96
- May 20, 2024
Biocon signs licensing and supply pact with Biomm S.A for Semaglutide commercialisation in Brazil

Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima. The total addressable market opportunity of Semaglutide in Brazil is approximately $580 million as per the IQVIA MAT Q4 2023. https://www.expresspharma.in/biocon-signs-licensing-and-supply-pact-with-biomm-s-a-for-semaglutide-commercialisation-in-brazil/
- Source: drugdu
- 132
- April 22, 2024
Mabwell reaches the Oversea Market of South Asia and Africa

Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa. 9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness. About 9MW0813 9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion ...
- Source: drugdu
- 195
- March 29, 2024
Henlius’ Trastuzumab Approved in Brazil, a Semi-Exclusive License Area, in Latin America

Recently, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), independently developed and manufactured by Henlius, has been approved to be marketed in Brazil for the treatment of HER2-positive breast cancer and gastric cancer. To date, the product has been approved for marketing in more than 40 countries and regions worldwide. Following the commercialization of HANQUYOU in Argentina, the approval of HANQUYOU in Brazil, the largest economy and the most populous country in Latin America, has become another anchor point for Henlius’ continuous global commercial expansion. Latin America and the Caribbean comprises 33 countries and regions with a total population of close to 660 million as of 2022 and a per capita GDP of close to $10,000 per capita [1]. In Latin America, breast and gastric cancers are the most and fifth most prevalent malignancies, respectively. The total number of new cases of breast and gastric cancer in the region in 2022 ...
- Source: drugdu
- 96
- March 22, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 173
- March 18, 2024
Hengrui Medicine’s new “PARP inhibitor” HRS-1167 combination therapy for advanced solid tumors received clinical approval

Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
- Source: drugdu
- 166
- March 15, 2024
FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health

Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
- Source: drugdu
- 120
- March 15, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
- 125
- March 10, 2024
Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines

Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
- Source: drugdu
- 131
- March 8, 2024
Qyuns Therapeutics passed the IPO hearing on the Main Board of the Hong Kong Stock Exchange

According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
- Source: drugdu
- 100
- February 28, 2024

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