Two developments are moving through the pharma world this week, according to Endpoints News.
Galderma has received a complete response letter (CRL) from the U.S. Food and Drug Administration for its drug relabotulinumtoxinA, which was under review as a neuromodulator. A CRL is the FDA's formal way of telling a company that it will not approve a drug in its current form, and that the agency wants more information or changes before it will reconsider. Endpoints News describes the product as an anti-wrinkle drug.
In a separate deal, Kimball is buying a contract development and manufacturing organization, or CDMO, for $103 million, per Endpoints News. CDMOs are the behind-the-scenes companies that help drugmakers develop and produce their medicines, and they have become increasingly sought-after as pharma firms lean on outside partners for manufacturing capacity.
Endpoints News notes that the same roundup includes further activity from other players in the sector, naming Lonza and Icosagen among others, though additional details were not provided in the item summarized here.
Why it matters: A CRL is a costly setback that can delay a drug's path to market by months or longer, while the steady stream of CDMO deals like Kimball's shows how much of modern drug development now depends on specialized manufacturing partners.