Latest From Brenda Sandburg
With the Winter Games approaching, case offers lesson for companies with complex advertising packages. Lilly told the agency two commercials featuring Olympic and Paralympic athletes were intended to run sequentially with another ad including indication and risk information.
Intellectual property became front page news in 2021 as the pandemic ignited a debate on the role of patents in accessing COVID-19 vaccines and therapeutics. 2022 will see a decision on the TRIPS waiver, a new USPTO director, and action on a pending march-in petition.
Big events from the year included the Biden Administration throwing its support behind the TRIPS waiver proposal, companies inking a slew of licensing deals, and the FDA asking the USPTO how it was addressing patent thickets.
Company execs say there has been four-fold increase in doctors infusing the Alzheimer’s drug and despite lack of support from major institutions, individual physicians at Cleveland Clinic and elsewhere have voiced support for Aduhelm. Biogen is “cautiously optimistic” about lecanemab Phase III trial.
Two-year journey after CRL did not start with a meeting with US FDA, but rather a ‘pause’ to better understand agency’s perspective, execs say. Firm would later develop a roadmap with FDA to overcome manufacturing issues for the the first tissue-based therapeutic approved by the agency.
The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.