Drug Delivery
The facility, which is part of Lilly’s $50 billion reshoring drive, will make obesity drugs such as tirzepatide and retatrutide when it starts operations in 2031.
FEATURED STORIES
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.
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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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.
Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.
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 obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
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.
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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.