Kelly Davio

January 21, 2020

Results for Truxima, recently launched in the United States, and complement inhibitors were presented at the 61st American Society of Hematology Annual Meeting and Exposition.

January 02, 2020

Splenomegaly, or enlargement of the spleen, is common in patients with Philadelphia-negative myeloproliferative neoplasms, and it is associated with symptoms like early satiety and abdominal pain. The role that splenomegaly has in terms of quality of life and prognosis in primary myelofibrosis is fairly well understood, but it has been less frequently investigated among patients with essential thrombocythemia (ET) and polycythemia vera (PV).

December 25, 2019

Drug maker Alnylam Pharmaceuticals has announced that the ILLUMINATE-A trial, a phase 3 study of lumasiran, an investigational RNA interference product targeting glycolate oxidase, met its primary end point in a study of patients with primary hyperoxaluria type 1 (PH1).

November 11, 2019

As healthcare companies, tech firms, and startups seek to use digital tools to help individuals manage their health, patients have growing concerns about how their data are used. During a panel discussion during the opening day of the FT Global Pharmaceutical and Biotechnology Conference 2019, held this week in London, United Kingdom, executives from across the pharmaceutical and digital health spaces discussed the critical importance of building relationships with patients as a means to not only reap high-quality data, but also improve patients’ outcomes and save healthcare systems money.

October 30, 2019

The FDA today approved Biogen and Alkermes’ diroximel fumarate, an oral agent, to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and secondary progressive disease. The drug, approved under the 505(b)(2) regulatory pathway on the basis of its bioequivalence to dimethyl fumarate (Tecfidera), will be sold as Vumerity.

October 28, 2019

The National Institutes of Health (NIH) has announced plans to invest at least $100 million over the next 4 years to develop gene-based therapies for 2 diseases: HIV and sickle cell disease. The Bill and Melinda Gates Foundation will also contribute $100 million to the goal of advancing these potential cures, with an aim toward providing affordable, globally available treatment that will be accessible to patients in low-resource settings.

October 21, 2019

While targeted testing for HIV has helped more individuals to be diagnosed and treated, the CDC recommends routine, universal HIV screening for all individuals aged 13 years to 64 years as a way to reach populations who may be less likely to seek out or participate in HIV testing. Emergency departments (EDs) in particular may play an important role in universal screening, as evidenced by the experience of 2 academic EDs in San Diego, California.

October 14, 2019

While antiretroviral therapy (ART) can suppress HIV infection, ART cannot completely eradicate HIV, which remains in a latent reservoir in CD4-positive T cells during treatment; discontinuation of ART leads to rapid rebound of the virus. This reservoir forms even when ART is initiated early on in the infection, and while the most widely accepted model of how the reservoir forms involves infection of a CD4-positive T cell as it transitions to a resting state, the dynamics and timing of the reservoir’s formation have been largely unknown.

September 27, 2019

From The Center for Biosimilars®, a discussion of a regulatory change coming in 2020: Insulins have always been biologics from a scientific perspective, and the products themselves will not change as a result of bringing them under regulation as biologics as a matter of law. However, labeling for these products will change.

September 09, 2019

Human leukocyte antigen c (HLA‐C), a protein encoded by the HLA-C gene, plays an important role in protecting against both cancer and viruses. At the same time, it has been implicated in autoimmune diseases, including rheumatic diseases, though the mechanism by which it contributes to the pathogenesis of these diseases is not yet clear.