A federal jury ruled that Johnson & Johnson must pay $247 million to settle claims that it failed to warn doctors and patients about possible defects with its Pinnacle artificial hips. J&J plans to appeal the ruling.
Auxilium, a unit of Endo International, is not liable for a heart attack suffered by a man who was taking the company's testosterone replacement drug Testim, a federal jury ruled last week. Endo is facing more than 1,200 other lawsuits involving Testim.
Johnson & Johnson's Zytiga, or abiraterone acetate, gained a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in combination with hormone deprivation therapy for expanded use in male patients with newly diagnosed high-risk hormone-sensitive prostate cancer before chemotherapy. The drug was previously approved for men with prostate cancer who have had prior docetaxel-containing chemo treatment.
Postdoctoral research fellow Christine Lattin studies non-native house sparrows' stress response not only to learn how to help animals as well as people survive extreme stress, but also to develop noninvasive research methods. Lattin has been targeted recently by animal rights activists and has become more vocal about her research in the hope of better educating the public about the benefits of animal research.
Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device -- codes that company officials think bring the device closer to positive coverage from public and private insurers in the US. The CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F) and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (CMS-1678-FC), according to Medtronic officials. The VenaSeal system uses a proprietary adhesive to close superficial veins in lower extremities in people suffering from symptomatic venous reflux, or varicose veins. The procedure, however, remains under a self-pay model since its FDA clearance and US launch in 2015. Read the story.
Intra-Cellular Therapies' schizophrenia drug candidate lumateperone was granted fast-track designation by the FDA.
The FDA gave orphan drug status to Revance Therapeutics' daxibotulinumtoxina injection, or RT002, which is being developed as a treatment for patients with cervical dystonia.
Late-stage studies of the Parkinson's disease candidate tozadenant were suspended by Acorda Therapeutics and development of the drug was halted after the deaths of five patients who developed agranulocytosis-associated sepsis during the trials. The company, which will immediately stop the dosing of the remaining patients enrolled in its studies, said the decision came after it received new information from the trials "related to previously disclosed agranulocytosis and associated serious adverse events."
Tasigna, or nilotinib, a drug developed by Novartis as a treatment for pediatric patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, gained approval from the European Commission and is indicated for use in the frontline setting or for those who experienced resistance or were intolerant to other treatment regimens.
The Nov. 15 recall of Casa Sanchez Foods' Real Guacamole has expanded to include Spicy Guacamole because of possible Listeria monocytogenes contamination. The expansion includes five lots with the UPC 0 78732 00431 3, 11 lots with the UPC 0 78732 00426 9 and 21 lots with the UPC code 0 78732 00412 2, which were shipped to California, Hawaii and Nevada.