Manufacturing
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
True inspection readiness is about the integrity of a company’s entire system.
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
Genentech, a member of the Roche Group, plans to open the facility in 2029 to ramp up capacity to make obesity candidates, including the dual GLP-1/GIP receptor agonist CT-388.
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
The past year saw manufacturing challenges pushed into the spotlight. BioSpace spoke to two executives who shared key issues facing those working in this area, from finding the right providers to dealing with regulatory uncertainty.
Johnson & Johnson’s second facility in Wilson, North Carolina, is part of a $55 billion push to make all advanced medicines used in the U.S. domestically.
AbbVie has also pledged to participate in TrumpRx and offer many of its products, including Humira, on a direct-to-patient basis. In exchange, the pharma secured exemptions from tariffs and other future pricing directives.
PRESS RELEASES