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Business Wire 12/09/2019 11:00
COPENHAGEN, Denmark--(BUSINESS WIRE)--Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, has launched the latest product in what is now marketed as its VANCO READYTM range of room temperature stable, ready-to-use (RTU) Vancomycin injection premix bags in the US.
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In addition, the Marketing authorisation holder (MAH) took the opportunity to implement the new excipient statement for sodium in section 4.4 of the SmPC, section 2 of Labelling and section 2 of the Package Leaflet.
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(MENAFN - America News Hour) Mannitol is a type of sugar alcohol which is also used as a medication. Mannitol is less absorbed by the body, hence it does not increase the insulin l...
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PR Newswire 12/08/2019 07:30
Contraindications Hypersensitivity to the active substance or to any of the excipients is contraindicated.
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End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially remove fluid and waste from blood and maintain appropriate electrolyte concentrations. For many patients on hemodialysis, an arteriovenous (AV) fistula is created to link an artery to a vein. Veins are too fragile for frequent access, but arteries are too […]
Seeking Alpha 12/05/2019 10:53
Based on my professional judgment, DAXI's longer lasting effect is due to it's stabilizing peptide excipient and low molecular weight.
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Policy & Medicine 12/05/2019 05:05
Last week, the US Food and Drug Administration (“FDA”) released a draft guidance which provides recommendations regarding the need for comparative clinical immunogenicity studies to support biosimilar insulin applications. The draft, entitled Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products, is intended to “facilitate the development of, and improve patient access to, life-saving insulin […] 12/04/2019 09:45
Condition : Multiple Myeloma Intervention : Biological: BCMA-CART cells Sponsors : PersonGen BioTherapeutics (Suzhou) Co., Ltd.; Second Affiliated Hospital of Suzhou University Recruiting.
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Healio News 11/26/2019 09:04
For example, a comparative clinical immunogenicity study may be needed if there are differences in certain impurities or novel excipients, but that would be a case-by-case scientific determination in the context of individual applications,” the FDA wrote.
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