Quantcast

Latest Veloxis Pharmaceuticals Stories

2014-08-20 16:24:51

HORSHOLM, Denmark, Aug. 20, 2014 /PRNewswire/ -- Highlights: -- On 28 July the European Commission granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). -- Following the European marketing authorization Veloxis will receive a milestone payment of USD 15 million from our European partner Chiesi in the third quarter 2014 which is in line with...

2014-07-28 04:21:40

HORSHOLM, Denmark, July 28, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) and Chiesi Farmaceutici S.p.A. today announced that the European Commission (EC) has granted marketing authorization for Envarsus(®) for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). Key points:

2014-06-30 08:29:40

- Result seen across stable and de novo kidney transplant patients - HORSHOLM, Denmark, June 30, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily Envarsus(®) XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf(®)). These study...

2014-06-03 16:25:04

HORSHOLM, Denmark, June 3, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the hiring of senior level management in preparation for potential U.S. commercialization of Envarsus(®) XR (tacrolimus extended-release tablets) an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients. Key points: -- Envarsus( )XR is an extended release formulation of tacrolimus being designed for once-daily...

2014-05-22 04:21:28

HORSHOLM, Denmark, May 22, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Envarsus® for the prevention of organ rejection in adult transplant patients in the European Union (EU). The positive opinion is for both kidney and liver transplant recipients and includes both the...

2014-04-28 12:31:12

- Study published online in Liver Transplantation - HORSHOLM, Denmark, April 28, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the publication of a Phase II study demonstrating conversion from twice-daily tacrolimus to once-daily Envarsus(®) in stable liver transplant patients in Liver Transplantation. Key points: -- Envarsus(®) is an extended release formulation of tacrolimus designed for once-daily dosing, flatter pharmacokinetics and greater...

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...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
Related