Ruth Bader Ginsburg’s Impact On Pharma, From Patents To The First Amendment
Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.
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Judge Jackson’s Patent, FDA Rulings Show She Is ‘Super Smart’ And Would Be Beneficial For Pharma
Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.
REMS In The Time Of COVID-19: ACLU Sues FDA Over Abortion Pill Access
Medical and advocacy groups claim FDA is requiring women to fill prescriptions for Mifeprex in person while waiving REMS requirement for in-person visits for other drugs.
Securities Fraud Class Action Suits Could Grow After Amgen’s Supreme Court Loss
Supreme Court rules 6-3 that plaintiffs do not need to prove that a company’s misrepresentations were material at the class certification stage; investors allege Amgen misrepresented the safety of Aranesp and Epogen.