Yutiq, or fluocinolone acetonide intravitreal implant, a non-bioerodible intravitreal micro-insert containing 0.18-mg fluocinolone acetonide in a 36-month sustained-release drug delivery system, was approved by the FDA to treat chronic non-infectious uveitis, which affects the eye's posterior segment. The decision was backed by data from two late-stage trials with patient follow-up for 36 months.
Researchers conducted a matching-adjusted indirect comparison study to assess the efficacy of ponatinib versus bosutinib in patients with chronic myeloid leukemia whose disease has advanced despite prior treatment with or intolerance to tyrosine kinase inhibitors. The findings, published in the journal Current Medical Research and Opinion, showed that ponatinib provided more significant clinical responses in the third-line treatment.
A La Carte Foods Properties issued a recall for 30,000 pounds of frozen, ready-to-eat jambalaya, gumbo and red beans entrees because they contain meat products that did not undergo federal inspection. The recalled products were sold in 12-pound packages, which bear establishment number EST. 13375 or P-13375 and were shipped to Texas and Louisiana.
The European Medicines Agency's Committee for Orphan Medicinal Products adopted a positive opinion on orphan drug status for Santhera Pharmaceuticals' POL6014 in the treatment of patients with cystic fibrosis. Santhera recently completed a successful early-stage safety and tolerability study of the candidate in cystic fibrosis patients and another Phase I study in healthy volunteers.
Roche has expanded its 2015 co-development and commercialization deal with SQZ Biotechnologies for antigen-presenting cell therapies that will be used to treat cancer. SQZ will be paid up to $125 million up front, and will also be eligible for $250 million in milestones for the resulting product, as well as royalties.
The $289 million penalty Bayer received in a recent trial that claimed glyphosate causes cancer is likely to be reduced or removed after the company was granted a new trial.
Biofuels appeared to be the best solution for zero emissions from ships in terms of availability and sustainability, according to a recent report, Zero Emission Vessels 2030. The UK report compared tests of biofuels, hydrogen and ammonia in five ship types and various ship sizes with data from a conventional ship.
Cleveland-based Sotera Medical, which is working on a device for protecting the esophagus during high-energy catheter ablation procedures intended for treating atrial fibrillation, has received an investment from Silicon Valley-based startup business accelerator Plug and Play. Chantel Moody, platform director of Plug and Play Cleveland, said the company's "compelling technology and impressive team" attracted the accelerator.
A preliminary prospectus has been filed by Valeritas for an offering of around 38 million shares of its common stock in hopes of raising $50 million.
A round of financing involving 29 investors has brought in $12.4 million for Cresskill, N.J.-based Vascular Therapies, bringing the company closer to its $21.1 million goal. The company makes a sirolimus-eluting collagen implant for use in patients with end-stage renal disease who depend on hemodialysis.