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FDA approves Medicines Co's ORBACTIV for use in acute bacterial skin and skin structure infections

Wednesday, 6 Aug 2014 08:31pm EDT

Medicines Co:Says that the U.S. Food and Drug Administration has approved ORBACTIV (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus.Says ORBACTIV is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration.Says Once fully infused over three hours, the ORBACTIV treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.

Endo International PLC raises FY 2014 guidance

Wednesday, 6 Aug 2014 05:00pm EDT

Endo International PLC:Raised FY 2014 revenues to a range from $2.78 -$2.86 bln, an increase versus prior range of $2.72 -$2.80 bln.Raised FY 2014 adjusted diluted EPS to a range from $4.00 to $4.20, an increase versus prior range of $3.80 to $4.00.Expects FY 2014 diluted (GAAP) loss per share to be in the range from $1.56 to $1.36.FY 2014 revenue of $2.75 bln, EPS of $3.97 - Thomson Reuters I/B/E/S.

DepoMed Inc raises FY 2014 revenue guidance and reaffirms FY 2014 EPS guidance

Wednesday, 6 Aug 2014 04:06pm EDT

DepoMed Inc:Raises FY 2014 total revenue guidance of about $215-$230 mln, which includes non-cash revenues related to the PDL transaction and $15 mln in milestones already received in 2014 from Mallinckrodt.Raises FY 2014 GAAP EPS of about $0.36-$0.51, which includes the non-cash PDL revenues and non-cash PDL interest expense.Reaffirms FY 2014 Non-GAAP adjusted EPS of break-even to $0.16.FY 2014 revenue of $192 mln - Thomson Reuters I/B/E/S.

Theravance Inc appoints Michael W. Aguiar as president and chief executive officer

Wednesday, 6 Aug 2014 04:05pm EDT

Theravance Inc:Appoints Michael W. Aguiar as President and Chief Executive Officer of the company effective Aug. 15, 2014 and as a member of the Board of Directors effective immediately.

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