Though pain hasn't traditionally been an area of focus for Eli Lilly & Co., the firm's burgeoning franchise includes two potential first-in-class candidates nearing regulatory filings. Coming out of a May 25 R&D review, analysts are thinking the pharma's new area of specialization may be significantly undervalued by investors.
Lilly Shows Off R&D Progress With A Pain Franchise Built On New Mechanisms
With galcanezumab for cluster headaches and migraine and tanezumab for osteoarthritis, lower back pain and cancer pain, Lilly soon could have an up-and-running pain franchise bolstering its long-term, internal R&D strategy.
More from United States
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.