FDA rejects regulatory approval application for Rezonic
LONDON The Food and Drug Administration rejected a regulatory approval application for a drug to prevent nausea and vomiting resulting from chemotherapy and surgical operations.
GlaxoSmithKline announced that it had received a complete response letter from the FDA’s Center for Drug Evaluation and Research for the drug Rezonic (casopitant mesylate).
The FDA issues a complete response letter when it rejects a regulatory approval application due to remaining questions or problems in the data used to support it.
GSK filed for approval of Rezonic last May.
GSK to develop inflammatory disease treatments with Chroma Therapeutics
LONDON British drug maker GlaxoSmithKline will collaborate with fellow British pharmaceutical company Chroma Therapeutics to develop treatments for such inflammatory diseases as rheumatoid arthritis.
GSK announced Tuesday that it would work with Chroma to use Chroma’s proprietary esterase-sensitive motif technology, which uses amino acid esters to make drugs target cells that cause inflammatory diseases.
Under the terms of the collaboration with GSK’s Center of Excellence for External Drug Discovery, Chroma will seek to discover new pharmaceutical drugs in four discovery and development programs, receiving a “significant” up-front cash payment and an equity financing investment by GSK, as well as potential milestones, royalties and option fees, including possibly more than $1 billion in milestones.
“This agreement marks GSK’s continued efforts to access the best science and technology platforms worldwide,” GSK VP and head of the European CEEDD Shelagh Wilson stated.
Takeda completes acquisition of IDM Pharma
OSAKA, Japan Japanese drug maker Takeda Pharmaceutical Co. completed its tender offer for a company that develops cancer drugs.
Takeda announced Tuesday that it had completed its tender offer to acquire all outstanding shares of IDM Pharma for $2.64 per share, with about 86% of IDM shares tendered.
The two companies originally agreed to the acquisition in May, with Takeda showing particular interest in IDM’s malignant bone cancer drug Mepact (mifamurtide), which European regulators approved in March for marketing in the European Union, Iceland, Liechtenstein and Norway.