Samantha DiGrande

January 26, 2018

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.

January 26, 2018

Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.

January 25, 2018

At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).

January 24, 2018

In an observational study conducted in Germany that began after the marketing authorization was received for reference trastuzumab in early breast cancer (EBC), researchers were able to analyze outcomes for patients treated with trastuzumab both with and without cytotoxic treatment.

January 23, 2018

Congress has passed a short-term spending package that will fund the government through February 8, 2018, and allow the FDA to resume normal operations.

January 21, 2018

The FDA and Commissioner Scott Gottlieb, MD, have made a number of announcements already in 2018. Here are 3 key regulatory developments that have taken place in the early days of January.

January 20, 2018

Japanese drug makers Kissei Pharmaceutical Company and JCR Pharmaceuticals have announced positive results of a phase 3 study for JR-131, a proposed biosimilar to darbepoetin alfa (Aranesp).

January 19, 2018

An editorial, recently published in Annals of the Rheumatic Diseases, discussed the results of a study that found that an adalimumab (Humira) concentration-based tapering strategy was not inferior to the conservative strategy, conducted over 26 weeks.

January 17, 2018

Yesterday, Novartis released new data from its head-to-head CLARITY study that shows that its secukinumab (Cosentyx) was significantly more effective than ustekinumab (Stelara) in the treatment of psoriasis in delivering clear or almost clear skin at 12 and 16 weeks.

January 17, 2018

FDA Commissioner Scott Gottlieb, MD, delivered the keynote address during a symposium, "Transparency at the US Food and Drug Administration,” hosted today by the Johns Hopkins Bloomberg School of Public Health. In his speech, Gottlieb announced a number of new initiatives to make the reasoning behind FDAs decision-making more transparent to all healthcare stakeholders.