FDA Commissioner Scott Gottlieb says agency staff is working with health care providers and the patient community to craft an opioid-drug policy that does not restrict access by patients with a legitimate need for the drugs while discouraging inappropriate prescribing and use. He also said the FDA will soon release a "comprehensive plan to promote competition and availability of biosimilars," and he noted that a staffing shortage might slow progress on other initiatives.
Johnson & Johnson unit Janssen Pharmaceuticals' Zytiga, or abiraterone acetate, in combination with prednisone was approved by the FDA as a treatment for patients with metastatic high-risk castration-sensitive prostate cancer. The drug, which was previously approved for patients with late-stage prostate cancer, reduced the risk of death by 38% versus placebo use in a late-stage study for CSPC patients.
Novo Nordisk's Rebinyn was introduced as a treatment for adult and pediatric patients with hemophilia B. Rebinyn can be used to control bleeding in cases where cuts or injuries occur, or for bleeding management during surgery, but is not recommended for regular use as a routine prophylaxis.
GlycoMimetics and the Haemato Oncology Foundation for Adults in the Netherlands will initiate a trial later this year to evaluate the efficacy of its experimental drug GMI-1271 in combination with the chemo agent decitabine as a treatment for newly diagnosed adult patients with acute myeloid leukemia and myelodysplastic syndrome who are intolerant to intensive chemotherapy. The primary goals of the 140-subject study consist of remission rate, disease-free survival and overall survival.
Sanofi said it will halt development of a half-dozen drug programs that include a Phase II study for isatuximab to treat acute lymphoblastic leukemia and GLD52 to treat relapsing multiple sclerosis. The company didn't say why the programs were being discontinued.
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Teva Pharmaceutical Industries warned that the approval and launch of its migraine drug fremanezumab could be delayed because Celltrion, which is the supplier of the drug to Teva, received a warning letter from the FDA. The company said it is working with the agency to keep the drug's priority approval date.
Smokehouse Pet Products recalled its Beefy Munchies pet food product, which was sold in Colorado, Michigan, North Carolina and Washington, over possible salmonella contamination. Pet food company Raws for Paws also recalled about 4,000 pounds of Ground Turkey Pet Food, distributed directly to consumers in Iowa, Minnesota and Wisconsin and through online mail order, for the same reason, with two illnesses connected to the pet food.
A study in the Journal of Glaucoma showed the use of Glaukos' iStent trabecular microbypass stent in cataract surgery demonstrated significant reductions in postoperative intraocular pressure and glaucoma medication use without intraoperative complications among patients with severe open-angle glaucoma. The heparin-coated nonferromagnetic titanium stent, implanted into multiple trabecular meshwork via one corneal entry point, is intended for the reduction of intraocular pressure.
The PICO 7 single-use negative-pressure wound therapy system was released in Europe by Smith & Nephew for patients who have a risk of poor healing in community and hospital settings. The system, which comes with an advanced vacuum and leak management, is intended for improved application on areas where a seal is difficult to be achieved and maintained.
Canadian regulators gave Siemens Healthineers approval to market its Symbia Intevo Bold SPECT/CT system, which is intended for various clinical applications in a dual-use setting. The system comes with the company's iterative metal artifact reduction algorithm to reduce metallic material-caused artifacts and the sinogram-affirmed iterative reconstruction algorithm for improved CT image quality and image reconstruction, among other features.
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