Login to Your Account



Regulatory NEWS
HONG KONG – Known already as the first China-manufactured biologic used in U.S. trials, HIV candidate ibalizumab (TMB-355) won FDA breakthrough therapy designation, which could substantially accelerate the product's launch.
A few months may not seem that long, but in the high-stakes, litigious world of biopharma, a loss of 57 days of patent protection could translate into hundreds of millions of dollars of lost revenue, especially if that patent covers a drug commonly used in combination with other HIV antiretrovirals.
BOGOTA, Colombia – Famous for its voluminous red tape, Brazil is now looking to make deals in the biopharmaceutical space a little easier, or at least easier to plan.
More Regulatory Headlines

Cast Your Vote

Has biotech’s bubble burst?: