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Clinical trial sponsors that are considering submitting data to the FDA based on Study Data Tabulation Model (SDTM) standards should provide early samples of data to familiarize agency reviewers with the new electronic format, experts say.
Biotech firm BioCryst plans to begin trials soon on an investigational flu drug that could be used against the avian flu virus H5N1 -- a development that comes amid new reports that some patients with avian flu are developing resistance to the current treatment Tamiflu.
Pharmaceutical companies are doing a better job making clinical trial data public, but some of the industry’s largest players are continuing to hide key information, according to a new study.
Breast cancer drug tamoxifen may not be as effective in women with a genetic trait that lowers levels of an enzyme necessary to activate the drug, according to a study by University of Michigan and Mayo Clinic researchers.
Novartis has terminated development of an experimental cholesterol-lowering drug after clinical studies showed the treatment was not more effective than existing medications.
Ranbaxy Laboratories announced positive clinical study results for its experimental malaria drug, RBx 11160, which it is touting as an affordable alternative to current therapies.
Bristol-Myers Squibb (BMS) inked a pair of collaboration agreements this week — one focused on developing novel cardiovascular disease treatments and the other on domain antibody products.
The Office of Human Research Protections (OHRP) needs to issue more definitive guidance about alternative models for institutional review board (IRB) review that explicitly divides responsibility between local and central review boards, according to clinical research stakeholders.
The HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) lauded a recent draft guidance on adverse event reporting at its recent meeting in Washington, D.C. SACHRP also grilled the FDA about when it could expect similar guidance from the agency.
Novartis' should provide additional safety and efficacy data before the FDA approves its proposed dosing regimen for Certican, suggests the agency's Cardiovascular and Renal Drugs Advisory Committee.