Biosimilars at the Bar

Scott M. Lassman participated in a panel discussion entitled Biosimilars at the Bar at AAM's GRx+Biosims Conference on November 4, 2019.  The panel discussed recent legal developments affecting biosimilars, including interchangeability, labeling carve-outs, enhancements to the Purple Book and regulatory pathways for approval of "biobetters."

Categories: Speaking

LMG Life Sciences: Scott M. Lassman Recognized As a Regulatory Law Star for 2019

Scott M. Lassman recently was recognized by LMG Life Sciences as a Regulatory Law Star in the areas of pharmaceutical and medical device regulatory law for 2019.

LMG Life Sciences evaluates attorneys on the basis of case evidence, peer feedback and client feedback.

Categories: Honors

New Developments in Biologics and Biosimilars

Scott M. Lassman is scheduled to speak about New, Emerging, and Continually Interesting Issues at the Food and Drug Law Institute's Introduction to Biologics and Biosimilars Law and Regulation on October 2, 2019 in Washington, D.C.

Categories: Speaking

Best Lawyers: Scott M. Lassman Recognized in the Areas of FDA Law and Administrative Law

Scott M. Lassman recently was recognized by The Best Lawyers in America as one of the leading lawyers in America in the categories of FDA Law and Administrative/Regulatory Law.

Best Lawyers' recognitions are based purely on the feedback received from lawyers already highlighted in the publication.

Categories: Honors

Lassman Law+Policy Client Braeburn Prevails in District Court on 3-Year Exclusivity Dispute

Lassman Law+Policy was privileged to represent Braeburn, Inc. (with co-counsel Goodwin) in securing this U.S. District Court ruling overturning an FDA decision on 3-year exclusivity as unreasonable and arbitrary and capricious. The decision, issued on July 22, 2019, orders FDA to reconsider "with deliberate speed" Braeburn's application for approval of an innovative new injectable treatment for opioid use disorder.  Read all about it here.

Categories: Other News

Lassman Law+Policy Placed on LMG Life Sciences Shortlist of "Regulatory Firms to Watch"

Lassman Law+Policy recently was honored by LMG Life Sciences by being placed on its "Shortlist" of Regulatory Firms to Watch in 2019.  Lassman Law+Policy is the only boutique firm specializing in FDA regulatory law to be recognized in that category.  Congratulations to the other nominees: Akin Gump, Debevoise & Plimpton, and Mayer Brown!

LMG Life Sciences evaluates attorneys on the basis of case evidence, peer feedback and client feedback.

Categories: Honors

Chambers USA: America’s Leading Lawyers for Business Recognizes Scott Lassman

Scott Lassman recently was honored by Chambers USA: America’s Leading Lawyers for Business. Mr. Lassman was named a Ranked Lawyer for 2019 in the area of Pharmaceutical/Medical Products Regulatory law.

The Chambers rankings are determined by independent research into a range of qualities and evidence of an attorney's work.

Categories: Honors

Biosmilars

Scott Lassman spoke on Biosimilars at the Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Conference in Washington, D.C.

Categories: Speaking

The First Amendment: Recent Developments and Impacts on Industry

Scott Lassman spoke on First Amendment issues at the Food and Drug Law Institute's Advertising and Promotion for Medical Products Conference in Washington, D.C.

Categories: Speaking

Hatch-Waxman and BPCIA Overview

Scott Lassman spoke on the Biologics Price Competition and Innovation and Hatch-Waxman Acts at ACI's FDA Boot Camp in Boston.

Categories: Speaking