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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-19/
- Published: 2020-05-03T12:00:00.000Z
- Updated: 2026-09-14T16:13:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135993

**Novo Nordisk** says its diabetes drug Victoza (liraglutide) injection 1.2 mg or 1.8 mg reduced the risk of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo in a recent trial involving 9,340 adults. “Victoza is the only approved GLP-1 receptor agonist to demonstrate a superior reduction of major CV events vs placebo, both on top of standard of care, in a cardiovascular outcomes trial,” the company says. “The expanded CV endpoint was significantly reduced by 12% with Victoza compared to placebo (95% CI: 0.81; 0.96, p=0.005). The expanded CV endpoint included the three components of the primary endpoint in addition to unstable angina leading to hospitalization, coronary revascularization and hospitalization for heart failure.

**Regulus Therapeutics** has entered into a $30 million loan and security agreement with **Oxford Finance** to provide additional working capital for advancing its clinical and pre-clinical development pipeline. The company says it is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for treating chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for treating of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. Also, Regulus says its RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for treating NASH in patients with Type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with **AstraZeneca.**

**Allergan** presented positive data at the 2016 ASM Microbe meeting in Boston showing *in vitro* activity of Avycaz (ceftazidime and avibactam) against several species of gram-negative pathogens, including certain strains of *Klebsiella pneumoniae* *carbapenemase* (KPC)-producing *Enterobacteriaceae* and *Pseudomonas aeruginosa*. Allergan says KPC-producing bacteria are a type of carbapenen-resistant Enterobacteriaceae (CRE), which the Centers for Disease Control and Prevention has identified as one of the three most urgent public health threats specific to antibiotic resistance. KPC accounts for about 85 % percent of all CRE infections in the U.S.

**Terumo** says it will acquire **Sequent Medical**, which is working on a device to treat intracranial aneurysms. The Japanese device maker will pay $280 million up front for the Aliso Viejo, CA-based startup, with an additional $100 million to follow if development or commercial milestones are achieved.

**Global Blood Therapeutics** has begun a Phase 2a study of GBT440, a hemoglobin modifier, in adults with idiopathic pulmonary fibrosis (IPF) and hypoxemia. The company says GBT440 has been shown to increase oxygen saturation in hypoxic conditions in preclinical studies. It adds that current IPF treatment “is targeted at slowing lung fibrosis but there has been no improvement in oxygenation and symptom burden of the disease.”

**Stealth BioTherapeutics** presented positive results from MMPOWER, a Phase 2 trial evaluating the systemic delivery of elamipretide for treating primary mitochondrial myopathy, or muscle weakness in patients with a genetically confirmed mitochondrial disease. The company says the study demonstrated statistically significant improvements with elamipretide in distance walked in six minutes, the study’s primary efficacy endpoint and an accepted measurement of functional exercise capacity.