> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-28/
- Published: 2020-09-27T12:00:00.000Z
- Updated: 2026-09-14T16:30:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135147

**CorMatrix Cardiovascular** has begun a feasibility study involving its tissue-engineered regenerative CorMatrix ECM Tricuspid Valve. The study at eight sites in the U.S. is intended to demonstrate proof of principle and initial clinical safety of the valve for the surgical management of tricuspid valve disease not amenable to annuloplasty or repair, including tricuspid valve disease secondary to congenital heart disease in pediatric and adult patients with tricuspid endocarditis.

**Valeant** says its board of directors has begun a search for a candidate to succeed **J. Michael Pearson** as chief executive officer. The company says Pearson will continue to serve as CEO and a director until his replacement is appointed. It also has filed a Form 8-K which identifies misstatements to date that would reduce previously reported fiscal year 2014 revenue by approximately $58 million, net income attributable to Valeant by about $33 million, and basic and diluted earnings per share by $.09.

**Janssen Research & Development** has entered into an agreement with **Genentech** to begin two studies to evaluate the safety and tolerability of Darzalex (daratumumab) in combination with atezolizumab in multiple myeloma and in solid tumor. Janssen says it will sponsor a Phase 1b, open-label, multi-center study to investigate the combination in patients with solid tumor. It adds that Genentech is the sponsor of an ongoing Phase 1b study that will be amended to assess atezolizumab in combination with daratumumab, with daratumumab and lenalidomide, and with daratumumab and pomalidomide in patients with relapsed or refractory multiple myeloma.

**Eli Lilly** says its Phase 3 clinical trial of solanezumab in patients with mild Alzheimer’s dementia will now view cognition, and not cognition and function, as the primary clinical endpoint for the trial. It describes cognition as that which measures the capacity to remember people and objects, while function measures someone’s ability to do tasks of everyday living such as walking or cooking. Lilly says the endpoint change will impact data analysis but won’t change the continuing conduct of the study.

**American Associated Pharmacies**, a member-owned cooperative of over 2,100 independent pharmacies in 49 states says it has reached an agreement to acquire the assets of **Partners in Pharmacy Cooperative,** an independent pharmacy cooperative with about 300 members in 19 states. AAP says it provides owners an opportunity to buy like a larger chain.