BC Week In Review | Jul 27, 2015
Clinical News

Envarsus tacrolimus regulatory update

FDA approved an NDA from Veloxis for Envarsus tacrolimus XR for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. The company...
BC Week In Review | Jun 29, 2015
Company News

Veloxis Pharmaceuticals transplant news

The U.S. District Court for the District of Columbia ruled that FDA was correct in granting tentative approval of immunosuppressant Envarsus tacrolimus XR from Veloxis to prevent organ rejection in kidney patients. The biotech filed...
BioCentury | May 25, 2015
Finance

Cash cravings

BioCentury's 13th annual European Iceberg survey foresees record financing demand, driven on the public side by higher burn rates and the number of companies joining the group via IPOs, and on the private side by...
BC Week In Review | Dec 22, 2014
Company News

Veloxis Pharmaceuticals transplant news

Veloxis filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus tacrolimus XR. In October, Veloxis said FDA granted tentative approval...
BC Extra | Dec 17, 2014
Company News

Veloxis sues FDA over tacrolimus delay

Veloxis Pharmaceuticals A/S (CSE:VELO) filed suit in the U.S. District Court for the District of Columbia seeking an order requiring FDA to grant final approval to immunosuppressant Envarsus XR tacrolimus and allow Envarsus XR to...
BC Week In Review | Nov 3, 2014
Clinical News

Envarsus tacrolimus regulatory update

Veloxis said FDA granted tentative approval to an NDA for Envarsus tacrolimus XR to prevent organ rejection in kidney patients, but said final approval will be delayed until expiration of the exclusivity period of Astagraf...
BC Extra | Nov 1, 2014
Politics & Policy

Veloxis respectfully begs to differ with FDA

Veloxis Pharmaceuticals A/S (CSE:VELO) plunged DKK0.63 (31%) to DKK1.40 on Friday after the company said FDA's tentative approval of immunosuppressant Envarsus XR tacrolimus will not become finalized until exclusivity expires for Astagraf XL tacrolimus from...
BioCentury | Oct 6, 2014
Finance

3Q14 Stock Wrap-Up: Going big again

For the second quarter in a row, only the large caps finished in the black in 3Q14. In the over $5 billion segment, which was up 9%, gainers outnumbered decliners 22-9, while the decliners led...
BC Week In Review | Aug 4, 2014
Clinical News

Envarsus tacrolimus regulatory update

The European Commission approved an MAA for Envarsus tacrolimus from Veloxis to prevent organ rejection in adult kidney and liver transplant patients. Veloxis said partner Chiesi Farmaceutici S.p.A. (Parma, Italy) plans to launch the product...
BioCentury | Aug 4, 2014
Finance

Highlights of weekly biotech stock moves

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell $4.44 (41%) to $6.39 on Monday after receiving a complete response letter from FDA for an NDA for Zalviso sufentanil sublingual tablet system to treat moderate-to-severe acute pain. AcelRx said...
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