Pharmacyclics LLC

FDA Approval of Axatilimab Marks New Era in Chronic GVHD Treatment

3 months ago

• Axatilimab, a CSF1R-blocking antibody, received FDA approval in August 2024 for chronic graft-versus-host disease treatment, demonstrating a 74% overall response rate in clinical trials. • Novel therapies including baricitinib, ixazomib, and teduglutide show promising results in treating steroid-refractory GVHD, offering new hope for patients resistant to conventional treatments. • Pharmacists play a crucial role in GVHD management through medication monitoring, patient education, and therapeutic drug optimization, contributing to improved patient outcomes.

HHS Expands Medicare Price Negotiations with 15 New Drugs Including Ozempic and Trelegy Ellipta

4 months ago

• The U.S. Department of Health and Human Services has selected 15 additional drugs for Medicare Part D price negotiations, targeting medications for diabetes, cancer, and asthma that account for $41 billion in Medicare spending. • The selected medications include popular drugs like semaglutide (Ozempic), Trelegy Ellipta, and Xtandi, with negotiations set to begin in 2025 and negotiated prices taking effect in 2027. • This second round of negotiations builds on the success of the first cycle, which achieved significant price reductions ranging from 38% to 79% on ten medications under the Inflation Reduction Act.

BeiGene's BRUKINSA Receives European Commission Approval for CLL Treatment

5 months ago

The European Commission has approved BeiGene's BRUKINSA (zanubrutinib) for treating adults with chronic lymphocytic leukemia (CLL), marking a significant advancement in chemotherapy-free treatment options. BRUKINSA has shown superior efficacy and a favorable safety profile in clinical trials.

EMA to Review Ibrutinib for Frontline Mantle Cell Lymphoma in Transplant-Eligible Patients

5 months ago

• Johnson & Johnson seeks EMA approval for ibrutinib plus R-CHOP for untreated MCL patients eligible for autologous stem cell transplant. • The application is based on the Phase 3 TRIANGLE study, which showed improved efficacy with ibrutinib-based regimens. • TRIANGLE study investigated ibrutinib with immunochemotherapy, with and without transplant, compared to standard immunochemotherapy followed by transplant. • Ibrutinib, a BTK inhibitor, has the potential to replace or complement transplant in frontline MCL treatment, according to the study.