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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-54/
- Published: 2021-12-05T12:00:00.000Z
- Updated: 2026-09-14T17:24:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5132361

**Astellas** and **Anokion** will create Kanyos Bio to collaborate on developing new treatments for Type 1 diabetes and celiac disease.

**DalCor Pharmaceuticals** and the **Montreal Heart Institute** will conduct an international Phase 3 clinical trial seeking to validate the clinical efficacy of dalcetrapib, that according to an MHI published could reduce cardiovascular morbidity and mortality by as much as 39% in patients with a documented recent Acute Coronary Syndrome and with the appropriate genetic profile. DalCor has licensed dalcetrapib from **Roche**.

**BD Medical**, a segment of **Becton, Dickinson** **& Co**., and **Medtronic** will collaborate to introduce a new insulin pump infusion set with BD FlowSmart technology. According to the companies, Medtronic will commercialize the infusion set, while BD manufactures the product in efforts to improve infusion set options for people with diabetes using insulin pumps.

**Celtaxsys** says it has completed a $40 million Series D financing, which will be supplemented by a $5 million grant from the Cystic Fibrosis Foundation Therapeutics, to help fund the company’s Phase 2 safety and efficacy trial of CTX-4430, a once daily, oral anti-inflammatory medicine for preserving lung function in cystic fibrosis patients. The company says CTX-4430 has been granted Orphan Drug Designation by FDA.

**Orexigen Therapeutics** and its North American partner, **Takeda Pharmaceuticals** have filed a lawsuit in the U.S. District Court for the District of Delaware against **Actavis** in response to the company’s filing of an ANDA for a generic of the weight loss drug Contrave (naltrexone HCl / bupropion HCl extended release) tablets prior to the expiration of U.S. patents listed in the *Orange Book*.