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Last updated on April 23, 2014 at 21:24 EDT

Latest Veloxis Pharmaceuticals A/S Stories

2014-03-15 08:21:40

In the news release, U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients, issued 13-Mar-2014 by Veloxis Pharmaceuticals, we are advised that the first bullet should read "FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 30, 2014" rather than "October 3, 2014" as originally issued inadvertently. The complete, corrected release follows: U.S. FDA Accepts Veloxis' New Drug...

2014-03-13 16:27:19

HORSHOLM, Denmark, March 13, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus(®) for the prevention of organ rejection in adult kidney transplant patients. Envarsus(®) is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology. Key points: -- FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA)...

2014-03-06 12:26:42

HORSHOLM, Denmark, March 6, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that John Weinberg, M.D., currently chief commercial officer of Veloxis, has been promoted to chief operating officer. -- Dr. Weinberg, who is currently responsible for the commercial launch of Envarsus® in the U.S., if approved by the Food and Drug Administration (FDA), will expand his role at the company to include additional operational responsibilities....

2014-03-05 08:29:33

HORSHOLM, Denmark, March 5, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2013. The annual report has been prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional Danish disclosure requirements for annual reports of listed companies. This company announcement should be read in conjunction with Veloxis' annual report 2013...

2014-01-08 12:30:01

HORSHOLM, Denmark, Jan. 8, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus(®). The subject patent covers a method of administering Envarsus(®), Veloxis' once-daily formulation of tacrolimus employing the company's proprietary MeltDose(®)...

2013-12-30 04:20:18

HORSHOLM, Denmark, Dec. 30, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus(®) (formerly LCP-Tacro(TM)) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and...

2013-12-24 08:23:55

HORSHOLM, Denmark, Dec. 24, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus(® )was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. Envarsus(®) is Veloxis' once-daily formulation of tacrolimus...

2013-12-11 08:30:33

HORSHOLM, Denmark, Dec. 11, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of ENVARSUS® (formerly LCP Tacro(TM)) in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of ENVARSUS®, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal...

2013-09-04 08:31:46

Veloxis Introduces Envarsus® as Trade Name for LCP-Tacro(TM) HORSHOLM, Denmark, Sept. 4, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that data from the 3002, randomized, double-blind, double-dummy, Phase III study in 543 de novo kidney transplant patients will be presented at the European Society for Organ Transplantation as a late-breaker oral presentation at 8:30 a.m. CEST, Sept. 9, in Vienna. Veloxis' once-daily LCP-Tacro(TM), now with the trade...

2013-06-27 12:28:21

- LCP-Tacro(TM), once-daily, demonstrated non-inferiority to Prograf®, twice-daily, based on the composite endpoint of treatment failure at one year (LCP-Tacro(TM) 18.3%, Prograf® 19.6%) HORSHOLM, Denmark, June 27, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced LCP-Tacro(TM) successfully demonstrated non-inferiority compared to tacrolimus (Prograf(®); Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized,...