Cosmo Pharmaceuticals' travelers' diarrhea drug candidate Aemcolo, or rifamycin SV MMX, was accepted by the FDA for review and given a PDUFA date of Nov. 16. In a late-stage study of patients with traveler's diarrhea, treatment with Aemcolo showed noninferiority to ciprofloxacin and superiority to placebo.
A Phase II clinical study was initiated by Inovio Pharmaceuticals for its drug candidate VGX-3100 to assess its efficacy in 24 adult patients who have human papilloma virus-related anal dysplasia. The company is recruiting HIV-negative patients with histologically confirmed anal or perianal high-grade squamous intraepithelial lesions that are associated with HPV-16 and/or HPV-18.
Abbott's Xience Sierra everolimus-eluting coronary stent system was approved by the FDA. The stent, which has longer lengths and better flexibility than its predecessors, along with the delivery system are intended to aid in the treatment of multiple or totally blocked vessels and other challenging cases.
The FDA gave Zimmer Biomet clearance to market its 3D-printed Zyston Strut Open Titanium Interbody Spacer System, a family of lumbar cages designed for improving the interbody spacer's graft capacity, visualization and strength during spinal fusion procedures. The system also includes surgical tools for facilitating implant insertion, manipulation and removal.
BIO launched an initiative in the industry to inform CEOs and board members that diversity leads to better financial performance and approved funding to help advance biotech leadership diversity at the board level. According to a McKinsey study, firms in the top quartile for cultural and ethnic diversity on executive teams were 33% more likely to have greater profitability.
A follow-on offering brought in $184 million for MyoKardia. The first patient in a late-stage Explorer-HCM study assessing its drug candidate mavacamten as a treatment of symptomatic, obstructive hypertrophic cardiomyopathy will be dosed this quarter.
Cara Therapeutics gave Vifor Fresenius Medical Care Renal Pharma the rights to market Cara's Korsuva, or CR845/difelikefalin, injection, which is indicated to treat patients with chronic kidney disease-associated pruritus undergoing dialysis, worldwide except in the US, Japan and South Korea. Under the terms of the deal, Cara will get $50 million upfront plus $470 million for regulatory and commercial milestones tied to sales.
The US and China are in talks to negotiate better access for Chinese imports of biotech crops as part of a trade deal. The discussion is nearing a deal that could see China buying more US farm biotech crops.
The Environmental Protection Agency and the Energy and Agriculture departments are scheduled to meet today to discuss President Donald Trump's planned changes to the country's biofuel laws. Trump wants to increase sales of higher-ethanol gasoline blends, count ethanol exports toward biofuel volume mandates and reduce the number of waivers that the EPA can grant small refiners.
A round of Series A financing brought in $13.4 million for UK-based Ultromics, a startup that is developing an artificial intelligence technology for coronary heart disease diagnosis. The proceeds will be used to commercialize the company's technology in the US and the UK, as well as for continued research and development efforts for new diagnostic support solutions.