Zydus receives final approval for Sirolimus TabletsMoneycontrol.comZydus receives final approval for Sirolimus Tablets. Zydus Cadila received the final approval from the USFDA to market Sirolimus Tablets 0.5 mg with 180 days of marketing exclusivity. S…
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“Therapeutic Polymeric Nanoparticles with mTOR Inhibitors and Methods of …
4-traders (press release) For example, disclosed herein is a therapeutic nanoparticle comprising about 1 to about 20 weight percent of a therapeutic agent (such as for example sirolimus, temsirolimus, or everolimus) and about 50 to about 99 weight percent of a biocompatible … |
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Waters Corporation : Study Findings from Waters Corporation Broaden …
4-traders (press release) According to news reporting originating from Milford, Massachusetts , by NewsRx correspondents, research stated, “LC-MS is increasingly used for therapeutic drug monitoring of tacrolimus. A recent summary from an international proficiency-testing … |
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Khon Kaen Sugar Industry PCL : Findings from Khon Kaen University in the Area …
4-traders (press release) The news reporters obtained a quote from the research from Khon Kaen University , “It has been reported that the clearance of tacrolimus in patients with the CYP3A5*1 allele was similar to 2.5-fold greater than that in those with the CYP3A5*3/*3 genotype. |
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Veloxis Pharmaceuticals Receives Notice of Allowance from US Patent Office for …
Wall Street Journal The subject patent covers a method of administering Envarsus(R), Veloxis’ once-daily formulation of tacrolimus employing the company’s proprietary MeltDose(R) technology, once-daily in the evening (as opposed to morning dosing) to a kidney transplant … |
Zale Corporation : Patent Issued for Therapeutic Polymeric Nanoparticles with …4-traders (press release)For example, disclosed herein is a therapeutic nanoparticle comprising about 1 to about 20 weight percent of a therapeutic agent (such as for exam…
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Clinical Studies and Financial Results – Research Report on Pfizer, United …
PR Newswire (press release) On November 8, 2013, Pfizer Inc. (Pfizer) released top-line results from its Phase 3B/4 study of RAPAMUNE® (sirolimus) evaluating kidney transplant patients who switched from tacrolimus-based therapy (TAC) to RAPAMUNE® 3 to 5 months after transplant. |
Veloxis Pharmaceuticals submits NDA to US FDA to market Envarsus for kidney …pharmabiz.comIn the two pivotal trials, Envarsus given once-daily met the primary endpoint of demonstrating comparable efficacy and safety compared to twice-daily tacrolimus…
NDA Submitted for Envarsus in Kidney Transplant ProphylaxisMonthly Prescribing ReferenceVeloxis announced the submission of a New Drug Application (NDA) to the FDA for Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in pati…
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US FDA grants orphan drug status to Veloxis Pharma’s Envarsus for kidney …
pharmabiz.com “FDA recognition of the potential of Envarsus as the only once-daily tacrolimus to be designated an Orphan Drug highlights these potential benefits. We continue to work on our New Drug Application (NDA), which we expect to submit by the end of 2013.” Envarsus Designated Orphan Drug for Kidney Transplant Rejection ProphylaxisMonthly Prescribing Reference |