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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-118/
- Published: 2019-06-09T12:00:00.000Z
- Updated: 2026-09-15T01:31:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5131591

**Sandoz** has agreed to pay $12.64 million to settle allegations it misrepresented drug pricing data to the Medicare program. HHS Office of Inspector General (OIG) says the settlement is the largest ever entered into under its drug price reporting civil monetary penalty (CMP) authority. OIG alleged that between 1/2010 and 3/2012 Sandoz misrepresented average sales price data to the Medicare program.

**MEI Pharma** reported that results of a Phase 2 study of its investigational drug Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS) showed no difference in the rate of complete remission, the study’s primary endpoint, compared to azacitidine alone. The company says the remaining data from event-driven endpoints, including duration of response, event and progression free survival and overall survival will require longer follow-up.

**GenVec, Inc.** has formed a collaboration with **TheraBiologics** to develop cancer therapeutics with GenVec’s gene delivery platform and TheraBiologics’ neural stem cell (NSC) technology. The companies says their initial goal is to generate a next-generation product candidate to TheraBiologics’ TBX02, which uses an established NSC line engineered to express a modified carboxylesterase enzyme that converts the prodrug CPT-11 (Irinotecan) to the chemotherapy agent SN-3.

**Novartis** says two-year data from an extension study of its Phase 3 FIXTURE and ERASURE trials demonstrate sustained efficacy with Cosentyx (secukinumab) with an acceptable safety profile for treating psoriasis patients. The data comes from the extension study of the pivotal Phase III FIXTURE and ERASURE trials. The company says Cosentyx is the first interleukin-17A (IL-17A) antagonist approved to treat adult moderate-to-severe plaque psoriasis patients.

**Eli Lilly** and Chinese biopharmaceutical firm **Innovent Biologics** will collaborate to develop and potentially commercialize three or more cancer treatments over the next decade. According to Lilly, it will contribute its cMet monoclonal antibody gene for possible treatment of non-small cell lung cancer and will continue development of the program outside of China. Also, the companies, says Innovent will contribute its monoclonal antibody targeting protein CD-20 for investigation in hematologic malignancies and a pre-clinical immuno-oncology molecule for development in China.