- FDA authorizes StemCells to conduct trial of product candidate in patients with age-related macular degeneration
- Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
- FDA removes clinical hold on trial of Idenix's investigational HCV therapy
- Discovery Labs' aerosol drug delivery system approved
- Merck's Janumet XR approved for type 2 diabetes
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA authorizes StemCells to conduct trial of product candidate in patients with age-related macular degeneration
What's This?
StemCells Inc. received notification from the Food and Drug Administration that the company can initiate a Phase I/II trial of its proprietary HuCNS-SC (purified human neural stem cells) product candidate in dry age-related macular degeneration (AMD). Investigators in the open-label, dose-escalation study will assess the safety and preliminary efficacy of the therapy in approximately 16 patients with dry AMD, the most common form of the condition. The treatment will be administered as...
StemCells Inc. received notification from the Food and Drug Administration that the company can initiate a Phase I/II trial of its proprietary HuCNS-SC (purified human neural stem cells) product candidate in dry age-related macular degeneration (AMD).
Investigators in the open-label, dose-escalation study will assess the safety and preliminary efficacy of the therapy in approximately 16 patients with dry AMD, the most common form of the condition.
The treatment will be administered as a single injection into the space beneath the retina. At predetermined intervals during a one-year period, the participants' vision will be evaluated using conventional methods of ophthalmological assessment. Thereafter, they will be followed for an additional four years in a separate observational study.
ThromboGenics reports FDA likely to grant ocriplasmin BLA priority review status 
What's This?
ThromboGenics NV said the Food and Drug Administration has indicated that it would grant priority review status to the firm's Biologics License Application (BLA) for ocriplasmin, an eye disorder treatment.In light of the FDA's intention, the company withdrew the BLA it submitted in late December for standard review and will resubmit a BLA for priority review by April. The...
ForSight VISION4 earns milestone payment from Genentech as part of agreement to develop sustained delivery formulation of Lucentis
What's This?
Genentech Inc. will make its first milestone payment to ForSight VISION4 Inc. as part of an exclusive license agreement to develop ForSight VISION4's investigational drug delivery device to provide sustained delivery of Genentech's Lucentis (ranibizumab).Genentech and its parent company, Roche, entered into the agreement with ForSight...
ThromboGenics seeks FDA approval of treatment for eye disorder
What's This?
ThromboGenics NV submitted a Biologics License Application (BLA) to the Food and Drug Administration to obtain approval of ocriplasmin 2.5 mg/mL, an intravitreal injection, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.The BLA contained data from two Phase III trials that involved 652 patients in the United States and Europe....
Akebia initiates early-stage trial of investigational treatment for diabetic macular edema, diabetic retinopathy
What's This?
Akebia Therapeutics Inc. started a Phase I study to assess AKB-9778 as a treatment for diabetic macular edema and diabetic retinopathy. The objective of the trial is to evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of AKB-9778 in healthy volunteers. Biomarker responses will also be measured to assess the drug's pharmacology. As many as 48 individuals will be enrolled in the study, which is expected to be...
- Avedro's VibeX granted orphan drug status as treatment for corneal ectasia following refractive surgery
- ThromboGenics seeks FDA approval of treatment for eye disorder
- RegeneRx's investigational dry eye drug misses primary endpoint in Phase II trial; company says trial data still indicate efficacy
- Compugen, BioLineRx to develop, commercialize peptide drug candidates
- Akebia initiates early-stage trial of investigational treatment for diabetic macular edema, diabetic retinopathy
- Avedro's VibeX granted orphan drug status as treatment for corneal ectasia following refractive surgery
- Compugen, BioLineRx to develop, commercialize peptide drug candidates
- ForSight VISION4 earns milestone payment from Genentech as part of agreement to develop sustained delivery formulation of Lucentis
- ThromboGenics seeks FDA approval of treatment for eye disorder
- RegeneRx's investigational dry eye drug misses primary endpoint in Phase II trial; company says trial data still indicate efficacy
