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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.

Gujarat Themis Biosyn Ltd announces changes in CEO and President

Wednesday, 6 Aug 2014 12:37pm EDT

Gujarat Themis Biosyn Ltd:Says Rajneesh Anand, President & CEO of stepped down with effect from Aug. 07.His services will however be available to Company as a Consultant from the same date.Appoints Tapas Guha as CEO of with effect from Aug. 07.

Biotec Pharmacon says U.S. Patent Office issues new patent for cancer adjuvant therapy

Wednesday, 6 Aug 2014 09:07am EDT

Biotec Pharmacon ASA:Says the United States Patent Office has issued a new patent for cancer adjuvant therapy.Says the patent US 8,791,252 is for a method of treating a variety of different cancers by administrating a combination of a (1,3) beta-glucan and a complement-activating antibody.Says the company has developed this concept together with Memorial Sloan-Kettering Cancer Center.Says holds an exclusive license on MSKCC's rights to this patent.

Health Canada Approves Celgene Corp 's ABRAXANE Plus Gemcitabine for first-line treatment of patients with metastatic pancreatic cancer

Wednesday, 6 Aug 2014 08:00am EDT

Celgene Corp:Says Health Canada has approved ABRAXANE for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer.Approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents first approved treatment for this disease in nearly two decades.Health Canada approval was based on results of MPACT, an open-label, phase III, randomized, international study which was published in New England Journal of Medicine in Oct. 2013.

Targacept Inc reaffirms FY 2014 revenue outlook

Wednesday, 6 Aug 2014 07:35am EDT

Targacept Inc:Says it continues to not expect significant operating revenues for FY 2014.

Lijun International Pharmaceutical (Holding) Co Ltd gives H1 2014 profit guidance

Wednesday, 6 Aug 2014 06:11am EDT

Lijun International Pharmaceutical (Holding) Co Ltd:Says the Group is expected to record an increase in the amount of net profit for H1 2014 as compared to the amount of net profit for H1 2013.Increase in the amount of net profit is primarily attributable to growth of the intravenous infusion solution business of the Group in the six months ended June 30.

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