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Keryx Biopharmaceuticals has finalized a special protocol assessment (SPA) agreement
with the FDA for the Phase III and Phase IV clinical trials of KRX-101, the
company's drug candidate for the treatment of diabetic nephropathy.
Callisto Pharmaceuticals, a biopharmaceutical company primarily focused on the
development of drugs to treat cancer and osteolytic bone disease, has announced
a second clinical trial of Atiprimod, its lead drug presently in a Phase I/IIa
trial in relapsed multiple myeloma patients.
GammaCan International, a developer of immunotherapies for cancer and other
serious conditions, has received approval from the institutional review board
of a leading medical center for the initiation of a clinical trial in Israel.
Join FDAnews Friday, March 25, for the 90-minute "Benchmarking Clinical
Trial Operations" audioconference, where your entire clinical operations
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for an audioconference on "Pharma & the HIPAA Security: 10 Critical
Changes to Make Before the April 20 Deadline." Make sure your organization
has implemented all the new administrative, physical and technical safeguards
required to meet the deadline for the HIPAA security rule.
Icagen has received a milestone payment from Yamanouchi Pharmaceutical related
to the selection of a compound for advanced preclinical studies as a result
of the collaboration between the two companies in dementia, including Alzheimer's
disease.
GTx, a biopharmaceutical company dedicated to the discovery, development and
commercialization of therapeutics for serious men's health conditions and oncology,
has completed a Phase I clinical trial of ostarine, the company's second selective
androgen receptor modulator (SARM) clinical product candidate.