Search Results for “EC” – Page 298 – media

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
- 81
- 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
- 101
- 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
- 98
- 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
- 99
- 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
- 83
- 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
- 89
- January 30, 2024
Asieris Presents for the First Time Interim Analysis Data of Oral APL-1202 in Combination with PD-1 Inhibitor Tislelizumab for Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer at 2024 ASCO-GU

Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for the Phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632）at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed. Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, ...
- Source: drugdu
- 93
- January 30, 2024
NHS urges more young people to take up HPV vaccine

HPV is a common group of viruses which can sometimes lead to cancer The NHS is urging both parents and young people between the ages of 12 and 13 years to take up having the human papillomavirus (HPV) vaccine to meet the NHS cervical cancer elimination goal. New figures from the UK Health Security Agency have shown that around one in six girls and one in five boys are not fully vaccinated by year 10. HPV is a very common group of over 100 viruses which affect the skin, sometimes causing genital warts or cancer. The HPV vaccine works to protect against a variety of cancers, including cervical, head and neck, anal and genital cancers. It is currently offered to all 12- to 13-year-olds within schools and community clinics and requires parental consent to receive the vaccine from NHS nurses. New statistics from the UK Health Security Agency has shown ...
- Source: drugdu
- 124
- January 30, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 96
- January 30, 2024
J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee’s pricing hearing

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
- Source: drugdu
- 148
- January 30, 2024

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