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The fast track designation will allow Bayer and Onyx to file a new drug application (NDA) on a rolling basis as data become available. This permits the FDA

The phase II study followed 32 patients with clinically diagnosed, MRI-confirmed progressive MS for 24 months, comparing safety and efficacy between MBP8298 and placebo administered intravenously every six

Pfizer and Schwarz Pharma entered into a global license agreement in April for Pfizer to acquire exclusive worldwide rights to fesoterodine, a new drug candidate for treatment for

Under the fast track designation, the FDA will help expedite the development and review of the MyVax personalized immunotherapy biologics license application (BLA) for approval. The regulator may

“This means Bayer must make a new offer to all Schering stockholders to acquire the shares they still own because Bayer now holds more than 30% of Schering

UT-15C is an oral sustained release formulation of treprostinil, the active ingredient in United Therapeutics’ Remodulin, which is currently marketed for subcutaneous and intravenous treatment of pulmonary arterial

ISIS 113715, a second-generation antisense drug, reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). PTP-1B is a mediator of insulin resistance, one of two main defects in patients

The JEWEL program, (JEWEL I and JEWEL II) funded by Pfizer, was comprised of two studies that were conducted in the UK and Canada (JEWEL I) and 11

The data, presented by Novartis at the meeting of the European Society of Hypertension in Madrid, Spain, demonstrated robust efficacy and a good safety profile for the drug