Disease burden heavy for SCD patients in US, despite promise of gene therapy
New report using real-world data cites care hurdles, need for multiple meds In the U.S., having sickle cell disease (SCD) continues to place a heavy clinical burden on patients, who often require multiple medications, frequent blood transfusions, and the use of opioids to control pain. Most individuals with SCD report high barriers to healthcare, with poor access […]
FDA rejects AZ’s subQ Saphnelo, but company expects quick turnaround for new approval decision
The FDA has rejected AstraZeneca’s subcutaneous version of lupus treatment Saphnelo, but the company is moving quickly to address the regulator’s concerns. (AstraZeneca) AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version of lupus treatment Saphnelo. The FDA has sent the British drugmaker a […]
Rheumatologists view CAR T-cell therapy as ‘revolutionary,’ but cost, safety temper enthusiasm
Although rheumatologists consider chimeric antigen receptor T-cell therapy “potentially transformative,” nearly 70% remain hesitant on whether its efficacy outweighs the possible risks, according to survey data from Spherix Global Insights. “We are standing at the threshold of major change in rheumatology,” Sawyer May, insights director of rheumatology at Spherix Global Insights, told Healio. “The survey data and clinical experience […]
AZ looks to grow reach in lupus with phase 3 win for self-administered Saphnelo
The full results from AstraZeneca’s phase 3 Tulip-SC trial build on the interim results that earned the drug a European approval last month. Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 […]
Novo’s oral semaglutide edges out CagriSema, Lilly’s orforglipron as PCPs’ most-anticipated obesity med
Oral semaglutide, which Novo has taken to calling “Wegovy in a pill,” is expected to receive an FDA decision before the end of the year. As both Novo Nordisk and Eli Lilly race to develop their long-anticipated oral GLP-1 obesity meds, a new report shows one taking a clear lead among potential prescribers. Spherix Global Insights surveyed […]
A Glimpse Inside the CLE Pipeline: What’s Coming Down the Pike?
Dermatologists rely heavily on topical therapies for cutaneous lupus erythematosus (CLE), but are increasingly interested in systemic agents with user-friendly formulations and dermatology-relevant experience such as deucravacitinib (Sotyktu BMS), an oral TYK2 inhibitor currently approved for psoriasis. Familiarity with its mechanism and a favorable safety profile have positioned deucravacitinib as a top contender for future […]