Industry Briefs

Eli Lilly’s Alzheimer’s Therapy Fails in Phase 3 Clinical Trial

Eli Lilly and Co. announced last week that the experimental Alzheimer’s medication solanezumab did not meet the primary endpoint in a phase 3 clinical trial that included approximately 2,100 patients with mild dementia due to Alzheimer’s disease.

Trial results showed that solanezumab failed to significantly differ from placebo in slowing cognitive decline in patients treated for 18 months with the amyloid-targeting monoclonal antibody.

“Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease,” the company stated in a release.

Zydus Issues Recall of Buprenorphine Hydrochloride Extended-Release Tablets

Zydus Pharmaceuticals USA Inc. has voluntarily recalled 20,537 bottles of 300 mg buprenorphine hydrochloride extended-release tablets (90-count bottles and 500-count bottles) that were made in India by the company’s subsidiary firm Cadila Healthcare, according to an FDA Enforcement Report.

The recall, which the FDA noted was due to “failed dissolution specifications,” has been designated a Class III recall—a classification indicating that the product is unlikely to cause any adverse health reaction but violates FDA labeling or manufacturing laws. ■