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BioMarin Pharmaceutical has announced positive results from the Phase III extension
study of rhASB (galsulfase), the company's investigational enzyme replacement
therapy for the treatment of mucopolysaccharidosis VI (MPS VI).
United Therapeutics has announced that AFSSAPS, the French drug regulatory agency,
has issued an approval letter for Remodulin injection for subcutaneous treatment
of NYHA Class III primary pulmonary hypertension patients.
Marshall Edwards has appointed a major international clinical research organization
(CRO) to project manage the final stages of the clinical program of the experimental
anticancer drug, phenoxodiol.
Geron has presented studies showing that its small molecule telomerase activators,
GRN139951 and GRN140665, enhance the functional activity of immune cells from
HIV/AIDS donors.
Peregrine Pharmaceuticals has announced the publication of data in Clinical
Cancer Research demonstrating significant antitumor activity in various
tumor models using the murine monoclonal antibody 3G4, an equivalent of the
company's Tarvacin, that recognizes anionic phospholipids exposed on the surface
of tumor blood vessels.
Corautus Genetics has announced the publication of the two-year follow-up results
of Corautus' earlier Phase I study of VEGF-2 in patients with severe angina.
Medarex and Bristol-Myers Squibb have announced results of an early clinical
study with the investigational fully human anti-CTLA-4 antibody, MDX-010, in
which eight of 36 patients with metastatic melanoma experienced objective clinical
responses (three complete responses and five partial responses).
Adventrx Pharmaceuticals has announced that the primary endpoint for response
rate was met in the study, "COFU: A multicenter Phase II clinical trial
to evaluate the safety and efficacy of weekly treatment with CoFactor and 5-fluorouracil
in patients with metastatic colorectal carcinoma."
BioDelivery Sciences International has received confirmation from the FDA that
the company will be able to utilize the FDA's 505(b)(2) regulatory pathway for
regulatory approval consideration of its licensed BEMA fentanyl formulation.
Cell Therapeutics has announced that while a Phase III study of Xyotax in combination
with carboplatin, known as STELLAR 3, missed its primary endpoint, it met statistical
significance for noninferiority of survival compared to paclitaxel in combination
with carboplatin.