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Arakis, a biopharmaceutical company focusing on inflammatory disease and oncology
adjunctive therapy, recently announced that its treatment for rheumatoid arthritis
("RA"), AD 452, has successfully completed a Phase IIa trial.
BioMarin Pharmaceutical has announced that it has randomized the first patient
in its Phase III clinical trial of Phenoptin, an investigational oral, small
molecule therapeutic for the treatment of the genetic disease phenylketonuria
(PKU).
NPS Pharmaceuticals today announced the results of two separate analyses of
its Phase III TOP study data that corroborate previous findings that PREOS improves
bone microarchitecture and reduces the incidence of first and subsequent vertebral
fractures in high-risk postmenopausal osteoporotic women.
GBL03-00 in Women
Genelabs Technologies has announced results of a preliminary analysis of a Phase
III clinical trial conducted by its licensee, Genovate Biotechnology.
Join FDAnews Thursday, April 14, to hear Lisa Olson of SEC Associates
explain what the FDA expects from computer systems you use to support your ongoing
clinical studies at the "Computer Compliance for Clinical Trials: What
FDA Expects in Adverse Event Reporting and Study Closure." Also learn from
Lisa Olson April 28 at the FDAnews audioconference on "Computer
Compliance for Clinical Trials: What FDA Expects for Recordkeeping and Archiving."
Get up to date on what the FDA expects for computer systems used in study recordkeeping
and archiving, the last phase in clinical trials.
Ligand Pharmaceuticals has earned a $1.5 million milestone payment from TAP
Pharmaceutical Products with TAP's submission of an investigational new drug
application to the FDA to evaluate LGD2941 as a potential new therapy for the
treatment of osteoporosis and frailty.
The FDA has approved a new intravenous administration formulation of AstraZeneca's
prescription proton pump inhibitor Nexium IV (esomeprazole magnesium).
Peregrine Pharmaceuticals and the National Institute of Allergy and Infectious
Disease (NIAID) have agreed to a collaboration in which NIAID's testing laboratories
will screen Peregrine's Anti-Phospholipid Therapy agents, including Tarvacin,
for activity against a broad spectrum of enveloped viral pathogens of health
and bioterrorism concern.
CoTherix has announced a collaborative research and development agreement with
Quadrant Drug Delivery to develop an extended-release formulation of CoTherix's
product, Ventavis inhalation solution.
Nastech Pharmaceutical has entered into a clinical research collaboration with
the Mayo Clinic to evaluate Nastech's RNA interference (RNAi)-based therapeutic
formulations in immune cells from patients with rheumatoid arthritis (RA) for
the purpose of selecting a candidate for preclinical and clinical development.