Leishen Energy | MedPath

Medicare's First Drug Price Negotiations Yield Mixed Results: U.S. Prices Still Exceed International Levels

6 months ago

• Medicare's first round of drug price negotiations achieved reductions ranging from 8% to 42% across ten medications, with sitagliptin showing the most significant price decrease. • Despite negotiated reductions, nine out of ten drugs remain more expensive in the U.S. compared to six other high-income countries, with only insulin aspart reaching international price levels. • Analysis reveals strategic pricing patterns, with biologics like etanercept, ibrutinib, and ustekinumab seeing 33-40% reductions, while negotiations appeared to align drug prices with therapeutic value.

Hemogenyx Pharmaceuticals Advances HEMO-CAR-T Therapy with New Funding and Clinical Trial Approvals

6 months ago

• Hemogenyx Pharmaceuticals secured £600,000 to advance Phase I clinical trials for its HEMO-CAR-T therapy targeting acute myeloid leukemia. • The company received IRB approval and completed a site initiation visit, marking significant progress towards opening clinical trials. • Share consolidation is underway to attract institutional investors and enhance the company's capital structure for clinical development. • Patient recruitment is imminent, with high demand anticipated at the cancer center collaborating on the HEMO-CAR-T trial.

AstraZeneca's Tezepelumab Shows Promise in Phase III Trial for Chronic Rhinosinusitis with Nasal Polyps

6 months ago

• AstraZeneca's tezepelumab demonstrated significant improvements in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in a Phase III trial. • The trial met its co-primary endpoints, showing statistically significant and clinically meaningful results in nasal polyp size and nasal congestion. • Tezepelumab represents a potential new treatment option for CRSwNP, addressing an unmet need for patients who do not respond well to existing therapies. • The safety profile of tezepelumab in this trial was consistent with previous studies, supporting its potential as a safe and effective treatment.

Cassava Sciences Faces Scrutiny as Simufilam Phase III Trials Continue Amidst Data Manipulation Allegations

8 months ago

• Cassava Sciences is proceeding with Phase III trials of simufilam despite a $40 million SEC settlement for allegedly misleading data from a Phase IIb trial. • The SEC alleges that a consultant manipulated Phase IIb trial data to show 'dramatic improvements' in Alzheimer's markers, and that Cassava misled investors about blinded trial conditions. • Experts question the ethics and validity of continuing Phase III trials based on potentially fraudulent data, raising concerns about patient safety and public trust. • The FDA's scrutiny of simufilam's efficacy and data veracity is expected to be heightened, though approval may still be possible if trials demonstrate independently verified efficacy.

Fasenra Receives FDA Approval for Eosinophilic Granulomatosis with Polyangiitis

8 months ago

• The FDA has approved AstraZeneca's Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). • The approval was based on the Phase III MANDARA trial, which demonstrated non-inferiority to mepolizumab in achieving remission. • Fasenra showed a significant proportion of patients could taper off oral corticosteroids, offering a crucial benefit. • This approval marks Fasenra as only the second biologic approved for EGPA, providing a new treatment option for this rare disease.