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Genentech has announced that a randomized Phase III study (E3200) of Avastin
plus the FOLFOX4 chemotherapy regimen, compared to FOLFOX4 alone in second-line
metastatic colorectal cancer patients achieved its primary endpoint of improving
overall survival.
OSI Pharmaceuticals, Genentech and Roche have announced that a randomized Phase
III clinical study of Tarceva plus gemcitabine chemotherapy in patients with
locally advanced or metastatic pancreatic cancer met its primary endpoint by
demonstrating a statistically significant 23.5 percent improvement in overall
survival when compared to patients receiving gemcitabine plus placebo.
Join FDAnews Jan. 31 and Feb. 23 to learn about "cGMP Predicate Rules:
What FDA Expects from Your Computer Systems." In this two-part audio tutorial,
Keith Benze of SEC Associates will identify and clarify the FDA's predicate
rules for computerized systems used in manufacturing processes. An unlimited
number of participants can attend at each registered site. For even more in-depth
training, plan to attend the "Compliance Boot Camp: Validation, Quality
and Communications Training for FDA Compliance" Feb. 7 -- 11 in San Diego.
Pozen has received a letter from the Committee on Safety of Medicines (CSM),
the Advisory Group to the UK's Medicines and Healthcare products Regulatory
Agency (MHRA), agreeing to advise MHRA that a marketing authorization be granted
for MT 100 in the UK, provided that Pozen supplies additional information
and meets certain conditions outlined in the letter.
Hi-Tech Pharmacal has been granted FDA approval for its abbreviated new drug
application (ANDA) for Ciprofloxacin Ophthalmic Solution USP, 0.3 percent.
The FDA has granted Marshall Edwards' investigational anticancer drug, phenoxodiol,
fast-track status for its intended use in patients with hormone-refractory
prostate cancer (HRPC).
GlycoGenesys, a biotechnology company focused on carbohydrate-based drug development,
announced a new indication, chronic lymphocytic leukemia (CLL), for its cancer
clinical trial program for GCS-100LE.
Alnylam Pharmaceuticals, a leading therapeutic RNA interference (RNAi) company,
is initiating a program to develop RNAi therapeutics for spinal cord injury
as part of its previously announced strategic collaboration with Merck &
Co. to develop RNAi therapeutics and technology.