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May 02, 2018
Article
The United States Pharmacopeial Convention (USP) announced that it will not be moving forward with its proposed revisions to drug product monographs for biologic medicines.
May 01, 2018
Article
Drug manufacturer Alexion has announced positive topline results of a phase 3 study that determined that ALXN1210, a long-acting C5 complement inhibitor, can be safely and effectively switched among patients with paroxysmal nocturnal hemoglobinuria currently being treated with the shorter-acting eculizumab (Soliris).
April 27, 2018
Article
This week, Frost & Sullivan—a global researching and consulting organization—together with Rani Therapeutics, a drug manufacturer developing an approach to the oral delivery of large-molecule drugs, announced the results of a combined research study. The study suggested that biosimilar developers could gain market share from brand-name biologics by developing the biosimilars in oral form.
April 25, 2018
Article
In a letter last week, patient advocacy group Patients for Affordable Drugs called on the Federal Trade Commission (FTC) to examine whether a pay-for-delay deal allegedly struck between reference adalimumab (Humira) manufacturer AbbVie with biosimilar developer Samsung Bioepis violates anti-competitive and antitrust laws.
April 24, 2018
Article
A case series was recently published in CNS Oncology that investigated whether adult pilocytic astrocytoma—a rare and highly vascular tumor—is responsive to bevacizumab treatment.
April 20, 2018
Article
At the American College of Rheumatology (ACR)’s State-of-the-Art (SOTA) Symposium, held last week in Chicago, Illinois, Judith James, MD, PhD, chair of arthritis and clinical immunology at Oklahoma Medical Research Foundation, presented a talk on precision medicine in rheumatology.
April 19, 2018
Article
Rheumatologists gathered from across the country last week to discuss the latest approaches in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases at the American College of Rheumatology’s (ACR) 2018 State-of-the-Art (SOTA) Clinical Symposium held in Chicago, Illinois.
April 18, 2018
Article
Over 370 centrally authorized products have been transferred to new rapporteurs located in the remaining 27 EU member states, Iceland, and Norway. The transfer followed a procedure developed by the EMA’s working groups on committees’ operational preparedness for both human and veterinary medicines in the wake of the United Kingdom’s withdrawal from the European Union.
April 17, 2018
Article
Amazon Business has hit pause on its plan to sell and distribute pharmaceutical products to hospitals after investigating the possibility last year.
April 16, 2018
Article
Last week, a federal appeals court in Maryland ruled that a law, passed in 2017 and aimed at combatting increases in the price of generic medicines, is unconstitutional.