The FDA has placed a partial clinical hold on two MacroGenics studies evaluating bispecific DART molecule MGD009. The hold is related to reports of liver-related adverse events, including high liver enzymes with or without concurrent elevations of bilirubin, and the company said it will amend protocols to address the events.
House lawmakers are expected to vote this week on bipartisan legislation that would permit the federal government to penalize pharmaceutical firms that misclassify drugs as generics to boost their profit from Medicaid, and Sen. Ron Wyden, D-Ore., one of the bill sponsors, said he hopes to see the measure become law by year's end. The measure is part of a legislative package that includes the ACE Kids Act, designed to improve care for children who have complex health needs.
Indian medtech companies have been waiting for 13 years for health authorities to comply with an order to create a comprehensive regulatory framework that would separate medical devices from pharmaceuticals. "[T]here is no need to reinvent the wheel here" because global benchmarks are available, as well as a task force for harmonizing rules, says Abby Pratt, AdvaMed's vice president for global strategy and analysis.
The FDA issued a warning letter to Alle Processing for temperature inaccuracy during recalibration of a thermometer, resulting in possible underprocessing of all low-acid canned foods products. Welter Farms and Jelliffe Dairy Farm also received warning letters for selling livestock for slaughter as food that had illegal levels of a sulfonamide antibacterial, and illegal antibiotic residues, respectively.
Globus Medical has launched its ExcelsiusGPS robotic guidance and navigation system globally following installations across Europe. The system, indicated to be used in open and minimally invasive orthopedic and neurosurgical procedures, is intended to be integrated with the company's instruments and implants and is compatible with intra- and pre-operative CT and fluoroscopic imaging.
Novo Nordisk's Novoeight has been approved by the FDA for control of bleeding episodes and for use as an on-demand therapy in adult and pediatric patients with hemophilia A, changing the previous label of the drug that indicates "control and prevention of bleeding episodes." The Warnings and Precautions section also has been updated to include additional data on neutralizing antibodies that can occur with Novoeight use.
Three posters covering rare types of lymphoma were presented at the annual meeting of the American Society of Hematology. These presentations discussed the safety of Bruton's tyrosine kinase inhibitors for mantle cell lymphoma; the elevated toxicity experienced by treatment-naive patients with peripheral T-cell lymphoma receiving Revlimid, or lenalidomide, plus cyclophosphamide, doxorubicin, vincristine and prednisone plus etoposide; and the effect of skipping consolidation radiotherapy in patients with primary mediastinal B-cell lymphoma.
Shire Pharma Canada's Adynovate, or antihemophilic factor (recombinant), PEGylated, a treatment for hemophilia A patients younger than 12 years, has been authorized for use by Health Canada. The agency approved the injectable factor replacement therapy Nov. 21, and the drug will be available to prevent and control bleeding episodes in pediatric patients, including use in surgical settings.
Industry veteran and Roche Holding executive Daniel O'Day has been named the new CEO of Gilead Sciences, replacing John Milligan, who will leave the company by year-end. Gregg Alton has been appointed interim CEO effective Jan. 1 until O'Day assumes his duties as CEO on March 1.
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