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Hengrui Medicine’s immunosuppressant tacrolimus sustained-release capsules were approved for marketing in the United States

Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
- Source: drugdu
- 126
- January 31, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 148
- January 31, 2024
EMA to support establishment of the African Medicines Agency

EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors. The European Commission’s Directorate-General for International Partnerships has signed an agreement with EMA marking the official launch of the project.AMA will be a specialised agency of the African Union (AU) dedicated to improving equitable access to quality, safe and effective medical products in Africa. To date, 27 countries have ratified the AMA treaty, and more AU members are expected to complete the process in the coming months. The creation of AMA is a unique opportunity to facilitate the regulation and oversight of key medicines at continental level, promoting collaboration among African countries and regions. Cooperation and collaboration are in the DNA of the European medicines ...
- Source: drugdu
- 99
- January 31, 2024
New Adjuvanted Recombinant Herpes Zoster Vaccine Phase I Clinical Study in China Completes Enrollment of First Batch of Subjects

At the kick-off meeting held at the Center for Disease Control and Prevention in Pu’er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial. REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline ...
- Source: drugdu
- 113
- January 31, 2024
Hengrui Pharmaceuticals’ Immunosuppressant Tacrolimus Extended-Release Capsules Approved for U.S. Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company’s abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company’s tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China. Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ...
- Source: drugdu
- 103
- January 31, 2024
EMA Grants Bersiporocin Orphan Drug Designation

Mike Hollan The agency recognized the medication as a significant advancement for the treatment of IPF. Daewoong Pharmaceuticals The European Medicines Agency (EMA) granted its orphan drug designation to bersiporocin, a medication developed by Daewoong Pharmaceuticals. The drug earned the title for its treatment of idiopathic pulmonary fibrosis (IPF). Daewoong Pharmaceuticals describes the drug as the world’s first PRS inhibitor for IPF. In a press release, Daewoong Pharmaceutical CEO Seng-ho Jeon said, “With Bersiporocin’s global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease.” IPF is a rare disease and only has about 13 cases per 100,000 people across the entire planet. It is a serious condition and the 5-year survival rate is about 40%. Patients with the condition suffer from a reduction of lung function due to a build-up of ...
- Source: https://www.pharmexec.com/authors/mike-hollan
- 114
- January 31, 2024
Globus lays off Nuvasive employees after merger

Globus Medical is laying off staff after the company merged with spine specialist Nuvasive. In California alone, the company is cutting more than 150 positions, according to documents reviewed by MedTech Dive. Nuvasive said it “will be laying off a number of its employees” in San Diego, where it was headquartered, according to a Jan. 3 notice shared with MedTech Dive by the California Employment Development Department. The affected employees were notified in the first week of January, and their last day of employment will be March 5, according to the document. Nuvasive’s San Diego office will remain open. A Globus spokesperson said the company is restructuring but declined to say how many positions were affected. “As part of our ongoing integration, we recently announced some organizational restructuring across the combined company in support of our committed synergy delivery,” the spokesperson wrote in an email. The California notice included a ...
- Source: drugdu
- 115
- January 30, 2024
Building a Digital Stockpiling Strategy One Shelf At A Time

The Covid-19 pandemic was a teachable moment for the medical device industry. It laid bare to vulnerabilities within the U.S. healthcare system, including how quickly our supply chain can be disrupted, the impacts on medical inventory and stockpiles of personal protection equipment (PPE), and staff shortages. In a survey by Ernst & Young, 57% of companies admitted facing serious disruptions during these times. In an industry where medical supply inventory is mission-critical, and disruption is not an option, it is important to revisit your health plan and pivot in strategies so when these unforeseen events occur, you are ready for anything that comes your way. From physical to digital Right now, considerable preparation is shoring up the physical equipment supply chain for frontline workers and patients. Truth be told, the impacts of having a digital health production plan are significant. While digital stockpiling is still an undervalued strategy among medical ...
- Source: drugdu
- 123
- January 30, 2024
Biosimilar Insulins Promise Patients New Choices, But Competition Is Still Lacking

Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
- Source: drugdu
- 93
- January 30, 2024
Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products

Don Tracy, Associate Editor Atypical antidepressant linked to severe adverse effects and death as a result of misuse. This week, the FDA released a statement warning consumers to stay away from Neptune Resources’ Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets. Citing potential adverse events (AEs) such as seizures, loss of consciousness, and death, the agency stated that they have continued to receive several reports of these AEs. After releasing an initial warning statement in November, the FDA sent a letter on January 11, 2024, to multiple retailers, stressing the need to pull Neptune’s Fix and any other tianeptine-containing products from their inventory. “Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label,” the agency said in the statement “These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or ...
- Source: drugdu
- 108
- January 30, 2024

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