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Latest From Brenda Sandburg
Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.
Patent Trial and Appeal Board invalidates patent on method to treat rheumatoid arthritis; next hurdle is overcoming formulation patents that do not expire until 2022.
New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.
Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.
Advisory committee votes for approval of 5-ALA for real time detection and visualization of malignant tissue during glioma surgery; data shows improvement in tumor resection, but not on survival metrics.
While other companies have promised not to raise their drug prices beyond 10%, Sanofi is using the rate of medical inflation (expected to be 5.4% in 2017) in setting its annual list price hikes. Company retains option to increase prices beyond benchmark.