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news.FDA panel recommends first OTC diet pill
The joint non-prescription drugs advisory committee voted 11-3 in favor of a low-dose version of the drug being made available over the counter. However GlaxoSmithKline’s consumer healthcare division
The joint non-prescription drugs advisory committee voted 11-3 in favor of a low-dose version of the drug being made available over the counter. However GlaxoSmithKline’s consumer healthcare division
2009 Outlook Looking forward to 2009, Bristol-Myers reaffirmed its GAAP per share earnings guidance of $1.58 – $1.73 and non-GAAP earnings outlook of $1.85 – $2.00 per share.
The two companies have now obtained all regulatory approvals required to close the transaction and have scheduled a closing date of January 26, 2006. Under the consent order,
The first-of-its-kind study in heart attack patients will seek to demonstrate the safety, and roughly measure efficacy, of three intravenous doses of adult human stem cells versus placebo
The majority of the company’s resources will now be deployed to complete a biologics license application (BLA) and prepare for the commercialization of Provenge. The 15% reduction in
The randomized study will include 270 pediatric patients undergoing stem cell transplantation at 30 clinical sites in Europe and Israel and will evaluate the ability of Defibrotide to
However, the US regulator has refused to accept a similar filing for the drug in the five-day treatment of acute bacterial sinusitis (ABS). The FDA is expected to
This trial is designed to explore a new schedule of delivery with PX-12 given as a 24-hour infusion every two weeks, and will evaluate the safety, pharmacokinetic profile,
A study at the University of Bangkok, Thailand, confirmed efficacy of the therapy against an H5N1 viral isolate. Meanwhile, researchers at the Public Health Agency of Canada demonstrated
The two pilot trials of denufosol were discontinued after the drug failed to produce improvement in either reduction of retinal thickness or improvement in visual acuity. Both trials