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The U.S. Patent and Trademark Office has granted a five-year patent-term extension
to United Therapeutics for its pulmonary hypertension drug Remodulin.
Takeda Pharmaceutical has received FDA approval for its angiotensin receptor
blocker (ARB) candesartan cilexetil for the treatment of heart failure (New
York Heart Association Class II-IV and ejection fraction less than or equal
to 40 percent) to reduce the risk of death from cardiovascular causes and reduce
hospitalizations from heart failure.
Biovail and Depomed have received an approvable letter from the FDA regarding
their new drug application for Glumetza, a once-daily, extended-release formulation
of metformin HCl for the treatment of Type 2 diabetes.
Vicuron Pharmaceuticals has received another milestone payment from Novartis
Pharma AG in recognition of follow-up lead product candidates identified for
Novartis' development from its ongoing research collaboration focused on peptide
deformylase inhibitors, a novel class of antibiotics.
Geron has published results of a completed Phase I/II clinical trial of its
telomerase therapeutic vaccine administered to patients with metastatic prostate
cancer at Duke University Medical Center.
The first patient has been dosed in SuperGen's Phase II clinical trial studying
Orathecin capsules and gemcitabine as a first-line combination therapy for advanced
pancreatic cancer patients who have not undergone chemotherapy.
Celgene has announced that external independent data monitoring committee (IDMC)
analyses of both Phase III special protocol assessment multiple myeloma trials
exceeded the pre-specified endpoint for stopping the trials.
Genzyme has announced that the European Commission has approved the company's
marketing application for a therapeutic indication for Thyrogen when used in
combination with radioiodine.