Kelly Davio

July 18, 2019

The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis and 45 with Crohn disease, at 14 centers in Italy.

July 17, 2019

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

July 16, 2019

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

July 15, 2019

Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.

July 12, 2019

Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

July 11, 2019

The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost product.

July 10, 2019

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

July 10, 2019

Spain-based drug maker mAbxience is developing a biosimilar rituximab, RTXM83. Last week, researchers reported findings from a head-to-head study of the proposed biosimilar versus its reference product as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).

July 09, 2019

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

July 09, 2019

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.