BioCentury | Oct 19, 2015
Clinical News

Dalvance regulatory update

...for review an sNDA from Allergan for a single-dose regimen of 1,500 mg IV Dalvance dalbavancin...
...the Phase III DUR001-303 trial (see BioCentury, May 11). The 2-dose regimen -- 1,000 mg Dalvance...
...24, 2014). Allergan plc (NYSE:AGN), Dublin, Ireland Product: Dalvance ( Xydalba - EU) dalbavancin ( RQ-00000002...
BioCentury | Aug 3, 2015
Company News

RaQualia, Durata Therapeutics deal

...RaQualia elected to regain Japanese rights to dalbavancin from Allergan plc (NYSE:AGN, Dublin, Ireland). In December...
BioCentury | Jul 13, 2015
Finance

Big news

...plc (NASDAQ:ALKS) Aripiprazole lauroxil Schizophrenia PDUFA date 8/22/2015 Allergan plc (NYSE:AGN) / Gruppo Angelini Dalvance dalbavancin...
BioCentury | May 11, 2015
Clinical News

Dalvance dalbavancin: Phase III data

...to FDA for the single dose regimen of IV Dalvance. The 2-dose regimen of IV Dalvance...
...aureus (MRSA). Actavis plc (NYSE:ACT), Dublin, Ireland Product: Dalvance dalbavancin ( Xydalba - EU) ( RQ-00000002...
...mg IV Dalvance met the primary endpoint of non-inferiority to a 2-dose regimen of IV Dalvance...
BioCentury | Apr 6, 2015
Finance

Up, up and acquired

...Exviera dasabuvir and Viekirax ombitasvir/paritaprevir/ritonavir to treat HCV infection Actavis plc (NYSE:ACT) EC approves Xydalba dalbavancin...
BioCentury | Mar 9, 2015
Clinical News

Xydalba dalbavancin regulatory update

...The European Commission approved an MAA from Actavis for Xydalba dalbavancin to treat acute bacterial skin...
...Independent States (CIS) (see BioCentury, Sept. 1, 2014). The second-generation glycopeptide antibiotic is approved as Dalvance...
...Nov. 24, 2014). Actavis plc (NYSE:ACT), Dublin, Ireland Product: Xydalba dalbavancin ( Dalvance ) ( RQ-00000002...
BioCentury | Mar 3, 2015
Company News

EC approves Actavis' Xydalba for ABSSSIs

...The European Commission approved an MAA for Xydalba dalbavancin from Actavis plc (NYSE:ACT) to treat acute...
...Extra, Oct. 6, 2014) . Actavis markets the second-generation glycopeptide antibiotic in the U.S. as Dalvance...
BioCentury | Feb 2, 2015
Clinical News

Xydalba dalbavancin regulatory update

...EMA’s CHMP recommended approval of Xydalba dalbavancin from Actavis to treat acute bacterial skin and skin...
...Staphylococcus aureus (MRSA). Actavis plc (NYSE:ACT), Dublin, Ireland Product: Xydalba dalbavancin ( Dalvance ) ( RQ-00000002...
BioCentury | Jan 12, 2015
Finance

Buyside view XXIII: Milestones galore

...Viekira Pak paritaprevir/ritonavir/ombitasvir plus dasabuvir (Holkira Pak - Canada) HCV Canada/U.S. Actavis plc (NYSE:ACT) Dalvance dalbavancin...
BioCentury | Nov 3, 2014
Clinical News

Dalbavancin: SPA received

...FDA for a Phase III trial to compare a single dose of 1,500 mg IV Dalvance...
...arm can switch to oral therapy after an initial period of IV treatment. Durata markets Dalvance...
...or early 2015. Durata Therapeutics Inc. (NASDAQ:DRTX), Chicago, Ill. Product: Dalbavancin ( Dalvance ) ( RQ-00000002...
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