Scientists from biotech firm Genus and the University of Edinburgh are developing pigs with potential resistance to porcine reproductive and respiratory syndrome using CRISPR-Cas9 gene editing technology. "Genome editing offers opportunities to boost food security by reducing waste and losses from infectious diseases, as well as improving animal welfare by reducing the burden of disease," says senior researcher Alan Archibald.
Exclusive global rights to research, manufacture and market abexinostat, a pan-histone deacetylase inhibitor, have been acquired by Wyoming-based Xynomic Pharmaceuticals. Xynomic plans to start global late-stage studies of the drug in the third quarter.
Auris Medical has received fast-track designation from the FDA for its acute sensorineural hearing loss drug candidate AM-111. Results from two late-stage studies of the drug are expected this year and before the end of 2018.
The FDA has given Intellipharmaceutics International approval for its generic version of Bristol-Myers Squibb's Glucophage XR, or metformin hydrochloride, for patients with type 2 diabetes. The drug will be sold in 500- and 750-mg strengths.
Fusion Pharmaceuticals, a spinout of McMaster University, has raised $25 million in a Series A funding round to help support cancer treatment studies. An early-stage trial of the company's FPX-01 for the treatment of solid tumors is expected to be completed in 2019.
Galenica and Nabriva Therapeutics received investments from Hong Kong-based Ally Bridge Group. Galenica operates through nephrology-focused Vifor Pharma, and Nabriva is conducting a late-stage trial of oral and IV formulations of the antibiotic lefamulin.
The carbon benefits tied to ethanol are improving at a higher rate than expected as a result of innovations in agriculture and manufacturing efficiency, according to a USDA report. Corn-based ethanol delivers a life cycle greenhouse gas emission reduction of 43% compared with gasoline and could reach an emissions reduction of up to 76% by 2022, writes Stephen Rapundalo, president and CEO of MichBio.
Cempra's CEM-102, or oral fusidic acid, has met the primary endpoint of a Phase III study in which the drug showed higher early clinical response rate than use of oral linezolid on 716 patients with acute bacterial skin and skin structure infections. Cempra needs to discuss with the FDA the regulatory pathway for the drug.
The death of a patient who was part of a Phase III clinical study to verify the safety and efficacy of Roche Holding's hemophilia drug candidate emicizumab has raised questions about the treatment's safety despite a trial investigator's ruling that the death was unrelated to the use of the regimen.
AstraZeneca's sodium zirconium cyclosilicate has been recommended for marketing approval by the European Medicines Agency's Committee for Medicinal Products for Human Use as a treatment for hyperkalemia based on the results of a late-stage study. The European Commission will consider the recommendation for the entire EU, as well as in Norway, Liechtenstein and Iceland.
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