Search Results for “EHR” – Page 5 – media

$2.2 billion settlement, GSK pays for safety

Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
- Source: drugdu
- 73
- October 14, 2024
Fosun Pharma achieves 100% control

On the same day of signing the Equity Transfer Agreement, Fosun Kate and Kite revised the original license agreement. According to the revised content, Fosun Kate has obtained exclusive rights to develop, produce, and commercialize Yikaida and Brexu Cel (Fosun Kate’s ongoing project FKC889) within the Kite license area (mainland China, Hong Kong, and Macau) and field (cancer treatment field). Kite will receive a tiered royalty fee of 7% to 13% of drug sales. For Fosun Kate’s pipeline assets, Kite has the right to receive a sales royalty of 2% to 4%. In addition, Fosun Pharma will increase its capital by $10 million in addition to the $27 million equity acquisition, to strengthen Fosun Pharma’s layout in the biopharmaceutical field. It is reported that four CAR-T therapies, including Achilles’ heel injection, have submitted application information in the upcoming 2024 national medical insurance negotiations. Kite, Fuxing Medicine and Gilead 2017 is ...
- Source: drugdu
- 71
- September 27, 2024
Cardinal Health Acquires ION for $1.115 Billion

Recently, Cardinal Health, the world’s ninth largest medical device company, announced that it has signed a final agreement to acquire Integrated Oncology Network (ION) for $1.115 billion (approximately RMB 7.861 billion) in cash to expand its oncology services business. INO is an independent community cancer center operator with over 50 clinics, more than 100 suppliers, and over 1000 healthcare workers in 10 states across the United States. It provides comprehensive care services for communities in areas such as medical oncology, radiation oncology, urology, and diagnostic testing. After this acquisition, all assets of ION will be integrated into the Navista Cancer Care division of Gardenor, and ION’s clinics will also receive Navista’s artificial intelligence analysis capabilities, as well as PPS Analytics platform support previously acquired by Gardenor through the acquisition of Specialty Networks. Navista is a subsidiary of Gardenor, a cancer diagnosis and treatment department jointly established with oncologists and clinic ...
- Source: drugdu
- 104
- September 25, 2024
Acquisition of Loss-Making Company to Consolidate Plasma Station Resources

Recently, TianTan Bio (600161.SH) announced that its controlling subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. (referred to as “Chengdu Rongsheng”) intends to acquire 100% of the shares of Wuhan Zhongyuan Ruide Biological Products Co., Ltd. (referred to as “Zhongyuan Ruide”), a wholly-owned subsidiary of CSL Behring Asia Pacific Limited (“CSL Asia Pacific”), for a total amount of $185 million (approximately 1.317 billion yuan). After the completion of this transaction, Zhongyuan Ruide will become a controlled subsidiary of TianTan Bio, and its financial statements will be consolidated. TianTan Bio indicated that it will add a new blood product production enterprise and five operational blood plasma collection stations. According to reporters from China Business Journal, Zhongyuan Ruide was acquired by CSL Asia Pacific between 2017 and 2018 through its subsidiary CSL Behring. However, after seven years, CSL Asia Pacific has chosen to sell at a discounted price. Additionally, the company is currently in ...
- Source: drugdu
- 107
- September 14, 2024
Spending 1.3 billion, Sinopharm Group strikes again

Recently, Tiantan Biological announced that its holding subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. intends to acquire 100% equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd., a wholly-owned subsidiary of CSL BEHRING ASIA PACIFIC LIMITED (Jetbehring (Asia Pacific) Co., Ltd.) for a total amount of US$185 million (nearly RMB 1.33 billion). Among them, the equity acquisition price is US$138 million, and the remaining amount is provided by Chengdu Rongsheng to Zhongyuan Ruide to repay the shareholder loan of CSL Asia Pacific to Zhongyuan Ruide (hereinafter referred to as “CSL”, “Zhongyuan Ruide” and “this acquisition”). After the completion of this transaction, Zhongyuan Ruide will become a holding subsidiary of Tiantan Biological, and its financial statements will be consolidated. For Tiantan Biological, this is a deal that adds icing on the cake. Blood products are a rigid demand track with extremely high barriers, and “whoever gets the plasma station will win the ...
- Source: drugdu
- 75
- September 9, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 70
- August 21, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 91
- August 14, 2024
Researchers reveal CAR-enhancer therapy could help overcome cancer relapse

Cancer is estimated to affect more than three million people living in the UK, according to Macmillan Cancer Support Researchers from the Dana-Farber Cancer Institute have revealed in a study that CAR-enhancer (CAR-E) therapy could help patients overcome cancer relapse. In the findings published in Nature Biotechnology, researchers report on a technique to prevent relapse and researchers hope to launch the first trial in the near future. It is estimated that there are more than three million people living in the UK with cancer, according to Macmillan Cancer Support, with breast cancer being the most prevalent, accounting for more than 55,000 new cases every year. A common challenge faced when using CAR T-cell therapies is that many patients, including those whose cancer has gone into full remission, eventually relapse. To eliminate this problem, the new techniques create what researchers consider a CAR-E therapeutic platform, which causes CAR T cells to ...
- Source: drugdu
- 111
- August 6, 2024
NHS Scotland, AZ and Scottish universities partner for kidney health research

NHS Scotland, AstraZeneca (AZ) and the Universities of Glasgow and Dundee have entered into a partnership to accelerate research into treating chronic kidney disease (CKD). The collaboration aims to develop new medicines to slow down the progression of CKD, build infrastructure and enhance expertise in renal clinical trial delivery in Scotland to improve patient outcomes. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition caused by decreased kidney function, commonly caused by diabetes, hypertension and glomerulonephritis. By preventing the progression of CKD, patients will live longer, better lives, free from other consequences of the condition, including heart failure, cardiovascular disease and stroke, while also reducing pressure on the NHS. In addition to slowing the progression of CKD, NHS Scotland, AZ and the Universities of Glasgow and Dundee will work to reduce the risk of patients potentially needing dialysis, a procedure to remove waste products and excess fluid ...
- Source: drugdu
- 108
- August 3, 2024
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency

AIRNA’s therapy for alpha1 antitrypsin deficiency, or AATD, edits RNA to address the underlying cause of this rare inherited disease. Wave Life Sciences and Korro Bio are both further along in the development of RNA-editing therapies for AATD, but AIRNA claims its therapy could be best in class. By Frank VinluanA particular protein deficiency that leads to liver and lung damage is currently treatable only with decades-old therapies that all have limitations. Biotech startup AIRNA is part of a field of companies developing novel treatments for this inherited disorder, and it aims to stand apart with a genetic medicine it contends could become best in class. AIRNA is preparing to advance this program to clinical testing and on Wednesday it revealed a fresh round of $60 million to support its plans. The disease that Cambridge, Massachusetts-based AIRNA aims to treat is alpha-1 antitrypsin deficiency, or AATD. This rare disease, affecting ...
- Source: drugdu
- 65
- August 3, 2024

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