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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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome