Drug Research
FDA approves Amphastar Enoxaparin Sodium Injection
The US Food and Drug Administration has approved Amphastar Pharmaceuticals' abbreviated new drug application for Enoxaparin Sodium Injection.The approval has been granted for 100mg/ml and 150mg/ml strengths. Enoxaparin Sodium Injection is the generic version...
Drug Research
Dey Pharma to provide EpiPen Auto-Injectors
Mylan's subsidiary Dey Pharma is set to offer EpiPen 2-Pak and EpiPen Jr 2-Pak (epinephrine) Auto-Injector 0.3/0.15mg exclusively for the emergency treatment of severe allergic reactions (anaphylaxis). EpiPen and EpiPen Jr Auto-Injectors are intended for...
Drug Research
Unilife develops safety syringe to reconstitute lyophilized drugs
Unilife has developed Unifill EZMix multiple-chamber ready-to-fill (prefilled) safety syringe for lyophilized drugs and vaccines requiring reconstitution.Unifill EZMix syringes comprises two or more drug containers within a single glass barrel to store a combination of liquid stable or lyophilized...
Drug Research
Allos recruits first patient in Phase 3 PTCL drug trial
Allos Therapeutics has recruited first patient in a Phase 3 multi-center, randomized, open-label (PDX-017) Phase 2 trial investigating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). Folotyn is approved in the...
Drug Research
Abbott two new strengths of CPP drug gets FDA nod
Abbott has received the US Food and Drug Administration (FDA) approval for two new strengths of Lupron Depot-PED (leuprolide acetate for depot suspension) to treat children with central precocious puberty (CPP). The application was submitted...
Drug Research
AVI BioPharma starts patient dosing in DMG drug Phase 2 trial
AVI BioPharma has started patient dosing in a placebo-controlled Phase 2 trial to evaluate eteplirsen as a treatment for Duchenne muscular dystrophy (DMD).The study intends to investigate the safety and efficacy of eteplirsen in DMD patients over 24 weeks...
Drug Research
Biogen Idec, Abbott release Select Phase 2b RRMS drug trial results
Biogen Idec and Abbott have released top-line results from a double-blind, dose-ranging, randomized and placebo-controlled Select Phase 2b trial evaluating the experimental compound daclizumab high-yield process (DAC HYP) in patients with relapsing-remitting multiple sclerosis (RRMS) over one year. ...
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