BC Week In Review | Oct 19, 2015
Clinical News

Dalvance regulatory update

FDA accepted for review an sNDA from Allergan for a single-dose regimen of 1,500 mg IV Dalvance dalbavancin to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant...
BC Week In Review | 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 2010, RaQualia granted Durata Japanese rights to the second-generation glycopeptide antibiotic. Allergan acquired Durata in November. The drug is...
BioCentury | Jul 13, 2015
Finance

Big news

The performance of big cap biotechs has lagged that of companies one tier down, but the second half includes a host of milestones that could put the bellwethers on a steeper upward trajectory. Buysiders largely...
BC Week In Review | May 11, 2015
Clinical News

Dalvance dalbavancin: Phase III data

Next quarter, Actavis plans to submit an sNDA to FDA for the single dose regimen of IV Dalvance. The 2-dose regimen of IV Dalvance is approved to treat ABSSSIs caused by susceptible Gram-positive bacteria, including...
BioCentury | Apr 6, 2015
Finance

Up, up and acquired

For the first time since 1Q14, none of the biotech market cap segments fell. While the $200-$499 million tier treaded water, all other segments finished in the black, led by the $1-$4.9 billion segment. Large...
BC Week In Review | 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 and skin structure infections (ABSSSIs) in adults. Gruppo Angelini (Rome, Italy) has exclusive rights to commercialize the once-weekly IV...
BC Extra | 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 bacterial skin and skin structure infections (ABSSSIs) in adults. The approval triggers a $1 contingent value right (CVR) payment...
BC Week In Review | 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 structure infections (ABSSSIs) in adults. The company markets the second-generation glycopeptide antibiotic in the U.S. to treat ABSSSIs caused...
BioCentury | Jan 12, 2015
Finance

Buyside view XXIII: Milestones galore

Stephen Hansen, Associate Editor and Jennifer Rhodes, Staff Writer   Buyside view XXIII The maturation of the biotech sector over the past few years finds fund managers focusing on a slew of clinical milestones and...
BC Week In Review | Nov 3, 2014
Clinical News

Dalbavancin: SPA received

Durata said it received an SPA from FDA for a Phase III trial to compare a single dose of 1,500 mg IV Dalvance plus a single dose of IV azithromycin vs. linezolid plus azithromycin in...
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