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news.BioSante initiates LibiGel Phase III trial for female sexual dysfunction
This is the second of two safety and efficacy trials to be conducted under conditions set forth in a special protocol assessment (SPA) agreement with the FDA. The
This is the second of two safety and efficacy trials to be conducted under conditions set forth in a special protocol assessment (SPA) agreement with the FDA. The
Arpida has requested a priority designation for the review of the new drug application (NDA). The iclaprim NDA contains data from 15 clinical studies, including two adequate and
The aim of this agreement is to secure commercial supplies of an appropriate scale to ensure the successful commercial launch of naproxcinod. The filing of a new drug
In this study, all doses of ciclesonide HFA (75mcg, 150mcg and 300mcg once-daily) met the primary efficacy endpoint and demonstrated a statistically significant reduction in 24-hour total nasal
The interim data from this ongoing Phase I/II clinical trial shows that tgAAC94 is well-tolerated at the highest dose tested in the trial and demonstrate that a higher
This payment is triggered by Pharmacopeia’s completion of certain early discovery activities established under its agreement with GlaxoSmithKline (GSK). Pharmacopeia is entitled to success-based milestone payments totaling up
Karl-Gunnar Hidinger, company’s president said that the single-blind trial will demonstrate DM-83’s level of effectiveness in controlling the blood glucose levels in twenty type 2 diabetics after they
Hi-Tech’s ofloxacin otic solution is the generic equivalent of Daiichi’s Floxin otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2007, had
Because the initial design goals of the HDL mimetic peptide therapeutic program have now been met, the company will now move rapidly to validate other key cardio-protective characteristics
The designation allows the company to have seven year market exclusivity for milatuzumab in multiple myeloma upon final approval by the FDA. Other financial benefits and incentives include