Thompson Coburn LLP的动态

In this article, Sills Cummis’ Beth Rose and Charlie Falletta discuss the ongoing legal battle over the osteoporosis drug Fosamax, manufactured by Merck. For the second time, the U.S. Court of Appeals for the Third Circuit vacated the U.S. District Court for the District of New Jersey’s judgment that plaintiffs’ state law failure-to-warn claims in the Fosamax litigation were preempted under federal law. Unless the Third Circuit’s decision is reversed, this decision revives hundreds of cases, many of which have been dormant since at least 2017. Read more in this article: https://lnkd.in/eSV4TMaB

Hunter DeKoninck will be presenting at the American Society for Pharmacy Law webinar on August 13. His presentation titled, "Perspectives on Changes to Agency Deference for Pharmacy Law (Chevron Decision)," will review the opinion in Roper, evaluate the impact of Chevron on current rulemaking with federal regulatory agencies, understand a post-Chevron world in relation to Congress and more. #pharmacy #PharmacyLaw #chevron https://lnkd.in/grr7fpNH

?? CDMO Trends You Need to Know! ?? Drug development costs are skyrocketing (Eroom’s Law), while new legislation aims to cut prices (Inflation Reduction Act), and patent strategies extend exclusivity (Patent Thicketing). ?? Discover more in our latest blog! https://bit.ly/4ckAwXc #CDMO #PharmaTrends #Investing #HealthcareIndustry

The Open Markets Institute filed an amicus brief with the U.S. Court of Appeals for the Third Circuit, urging the court to grant a rehearing In re Merck Mumps Vaccine Antitrust Litigation. A class of physicians alleged that Merck misled the Food and Drug Administration about the shelf-life of its vaccine and thereby kept out a competing vaccine. Authored by Sandeep Vaheesan, Tara Pincock, and counsel of record Jason Rathod, the brief supports the plaintiffs-appellees’ petition for an en banc rehearing, emphasizing that granting absolute immunity for material misrepresentations to agencies like the FDA encourages firms to build and maintain monopolies by lying to regulators. “Allowing corporations to abuse judicial and regulatory processes through misrepresentations is dangerous,” said Sandeep Vaheesan, Legal Director at the Open Markets Institute and an author of the brief. “It empowers corporations like Merck to extend their monopolies through regulatory mischief and undermines the decision-making of agencies like the FDA.” READ the brief: https://lnkd.in/empnvcdH

New blog post on a skinny-labeling proposal. Check it out on the FDA Law Blog! https://lnkd.in/ehD5kMmZ

Thoughts on this? >> Large group of state attorneys general backs Oregon drug price transparency law >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #pharma #pharmaceutical #productmarketing

The new Life Sciences Comparative Guide has been launched as a joint project between Clifford Chance and The Legal 500. The aim of the Guide is to provide readers with a pragmatic overview of life sciences law across a broad variety of jurisdictions. Each chapter provides information about the current issues affecting life sciences practice in a particular country and addresses topics such as legislative framework, regulatory processes, advertising, restrictions, risks of liability and compliance standards as well as insight and opinion and any upcoming legal changes planned for their respective country. You can check out the Guide here: https://lnkd.in/dKZrjmqZ

As lawsuits against Pfizer, the manufacturer of Depo-Provera, gain momentum, the Judicial Panel on Multidistrict Litigation is expected to decide whether to consolidate these cases into a multidistrict litigation (MDL). This decision will shape the course of litigation for affected individuals nationwide. Read more here: https://hubs.ly/Q034L_7M0

As expected, it looks like FDA's final rule on regulating laboratory-developed tests (LDTs) is being challenged in court. Interestingly, the lawsuit was filed in Texas, following a growing trend in some circles of filing challenges to federal agency authority in Circuits viewed as less friendly to the exercise of regulatory authority by the federal government. This will definitely be an interesting case to watch. #fda #ldt #Cheveron

Charged with drug production? Understanding the legal framework is key. From the definition under the CDSA to potential penalties and defence strategies, we’ve got you covered. https://lnkd.in/gNCYKwzk