The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis.
In July 2022, clinical trial data was published
Goodwin Procter Blogs
Latest from Goodwin Procter
ESG Considerations for Public Companies
Environmental, Social, and Governance (ESG) issues continue to be top of mind for public companies. Some companies are just starting their ESG journey while others are working towards establishing best in class ESG practices. To assist public companies with navigating
Antitrust + Competition Life Sciences Quarterly Update Q2 2022
Although the second quarter did not feature any life sciences enforcement action by the FTC, there was plenty of news in and around the space. The FTC held a detailed “virtual workshop” as part of its pharmaceutical merger task force
Amgen Moves to Dismiss and to Stay Regeneron’s Antitrust Case
We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. Amgen recently filed a motion to dismiss Regeneron’s Complaint and a motion to stay the case.
The case concerns Regeneron’s allegation
Infliximab Clinical Trial Updates
The Big Molecule Watch is monitoring clinical trial activities involving infliximab. Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb).
Earlier this year, clinical trial data was published from an observational real-world study of patients with inflammatory bowel disease,
U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022,[1] which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003. The
Denosumab Clinical Trial Updates
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies.
On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar
Special Meeting Reminders
With annual meeting season having concluded for calendar year-end companies, some companies are contemplating holding special meetings for various proposals that cannot wait until next year’s annual meeting. Set forth below are five key reminders regarding the proxy rules and
U.S. Crypto Regulation and the Digital Commodities Consumer Protection Act
Goodwin partner Grant Fondo was recently interviewed on CoinDesk TV in regards to the Digital Commodities Consumer Protection Act that was introduced on Wednesday, August 3, 2022. The proposed legislation suggests that the CFTC should control crypto spot markets, specifically
Celltrion Files IND with FDA for Adalimumab Biosimilar
As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab). The trial will