Kelly Davio

April 23, 2018

After spinal cord injury, oxidative stress, inflammation, and mitochondrial dysfunction can cause neural damage that was once believed to be both immediate and irreversible. However, neuronal death is now believed to proceed over a period of several days after initial trauma, and to include cellular, molecular, and biochemical cascades, including local inflammatory responses. Tumor necrosis factor is believed to be involved in the local production of cytokines at the site of the injury.

April 23, 2018

Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.

April 21, 2018

This week, Scott Gottlieb, MD, Commissioner of the FDA, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.

April 19, 2018

In the case study, the authors report findings from a comparability assessment of epoetin alfa before and after a proposed manufacturing process change for which, they say, nonclinical assessment of structure-function relationships were not sensitive enough to identify clinically relevant differences resulting from differences in the drug’s glycosylation profile.

April 18, 2018

Since 2017, the Italian National Agency for Drugs has approved of the off-label use of infliximab and adalimumab for juvenile idiopathic arthritis-associated uveitis, and has created a patient registry to collect anonymized data from patients in 24 pediatric rheumatology and ophthalmology centers across Italy.

April 17, 2018

Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.

April 16, 2018

The researchers found that a high proportion of microbiota of the Betaproteobacteria class and Burkholderiales order prior to treatment was associated with clinical response at 3 months.

April 13, 2018

This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.

April 12, 2018

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.

April 11, 2018

Researchers demonstrated that trastuzumab increased progression-free survival (PFS) in patients with uterine serous carcinoma.