Teva files 4th petition to get FDA to impose restrictions on filings for generic Copaxone.
The Supreme Court granted Amgen’s petition to review a securities fraud case in which plaintiffs alleging Amgen misrepresented the safety of Aranesp and Epogen were granted class certification. At issue is whether those seeking class certification must show a company’s alleged misrepresentation was material, and whether the defense can present evidence rebutting fraud at the class certification stage.
BioSante plans to double down on LibiGel for hypoactive sexual desire disorder in menopausal women with two new Phase III studies designed to minimize the placebo response that thwarted the statistical significance of treatment arm findings in previous trials
