Topic: Biotechnology

JD Supra Corporate Brief: Internal Controls, Broker Dealers, Unfair Competition, Conflict Minerals

Is it just us, or is it getting really hot in here? But don’t worry – the heat wave should break by before the weekend. Until then: stay cool, drink lots of liquids, and read the JD Supra Corporate Brief: M&A risks: all too often executives ignore ethics and compliance issues and focus mainly on… Read more »

Attorney: Myriad Decision Shows SCOTUS Striking Necessary Patent Law Balance

“You know you’re living in the end of days when both the ACLU and the Wall Street Journal praise the same Supreme Court decision…” – Gideon Schor Here’s an interesting perspective on yesterday’s Supreme Court decision in AMP v. Myriad from Gideon Schor, litigation partner at Wilson Sonsini Goodrich & Rosati [bold ours]: “…The Court… Read more »

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »

Biosimilars Benefit From Health Care Reform Decision

“With [the] Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern. Presumably it will be full speed ahead through the regulatory process, and we will see biosimilar applications for approval and attendant patent litigation before too… Read more »