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# Since Our last Issue...
- URL: https://www.fdaweb.com/since-our-last-issue-14/
- Published: 2020-03-22T12:00:00.000Z
- Updated: 2026-09-14T16:08:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135798

Clinical-stage oncology company **ProNAi Therapeutics** has obtained an exclusive license from **CarnaBiosciences**, Kobe, Japan, for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7\. According to the companies, ProNAi will pay Carna Biosciences an initial upfront payment of $0.9 million and additional potential payments upon achieving certain developmental, regulatory and commercial milestones of up to $270 million. According to the ProNai CDC7 (cell division cycle 7) is a serine-threonine kinase positioned as an essential regulator of both DNA replication and DNA damage response, two critical functions required for tumor cell survival. **Symbiomix Therapeutics** reports positive results from the second pivotal trial of its SYM-1219 (secnidazole) for treating bacterial vaginosis (BV). The company says the Phase 3 randomized placebo-controlled trial in 189 women compared a single, oral dose of SYM-1219 to a placebo in both patients with infrequent BV and those with recurrent BV. It adds that SYM-1219 achieved statistically and clinically significant results across all primary and secondary endpoints. Specialty pharmaceutical company **Armetheon, Inc**. has completed the acquisition of budiodarone, an anti-arrhythmic agent in Phase 2 development. The company says it plans to develop the product candidate for treating ventricular tachycardia in patients with implantable cardioverter defibrillators. It adds that budiodarone has displayed in preclinical and Phase 2 clinical studies rapid onset and offset of action, and its elimination is not CYP450-dependent, suggesting a lower potential for drug interactions. **Thermo Fisher Scientific** and Hillsboro, OR-based electron microscopy maker **FEI Company** say that their boards of directors have unanimously approved Thermo Fisher’s acquisition of FEI for $107.50 per share in cash, representing a purchase price of about $4.2 billion. The companies say FEI’s high-end electron microscopes are complementary to Thermo Fisher's mass spectrometry systems used for protein identification and characterization. **Ionis Pharmaceuticals** reports that partner **GlaxoSmithKline** has decided against initiating a Phase 3 study of a drug (Ionis-TTR) they are developing for treating transthyretin amyloid cardiomyopathy, a condition in which the misfolded transthyretin protein accumulates in the cardiac muscle. Recently, FDA placed a hold on Glaxo’s Phase 3 study of Ionis-TTR, while, according to Ionis, Glaxo provided answers to FDA questions about the Phase 3 study protocol stemming from Ionis’ ongoing Phase 3 NEURO-TTR study of the drug in patients with TTR familial amyloid polyneuropathy.