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While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
In a bid to cut down on orphan drug developers wasting agency time, the FDA is outlining new, detailed guidelines for what constitutes a legitimate topic for formal and informal presubmission meetings. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions. Read More
Alkermes says its once-monthly injectable version of the antipsychotic blockbuster Abilify met its endpoints in a Phase III trial, setting it up for an NDA filing with the FDA sometime in the third quarter. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Amgen’s investigational metastatic melanoma candidate talimogene laherparepvec met its primary endpoint of durable response in a Phase III clinical trial, but missed the secondary endpoint of overall survival, the drugmaker said. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More