-
Orchestra BioMed receives FDA approval
01 May 2025 16:26 GMT
… the Treatment of Coronary ISR Trial.
The IDE provides FDA regulatory … & Vascular Institute, medical director of The Christ … field largely reliant on paclitaxel drug-coated balloons, Virtue … drug-eluting stents. Published meta-analysis involving 76 trials …
-
AstraZeneca's highly touted Truqap flunks another phase 3 trial
30 Apr 2025 13:18 GMT
… first-in-class cancer treatment.
Alongside its first-quarter … survival.
The CAPItello-280 trial was evaluating Truqap added … added to the chemotherapy paclitaxel.
In a conference call … looming Trump administration tariffs on pharmaceuticals, AZ said that it …
-
AstraZeneca’s Truqap fails in another Phase III trial
30 Apr 2025 10:31 GMT
… discontinued a Phase III trial of Truqap (capivasertib) after … was consistent with other trials.
This is another blow … was investigating the drug in combination with paclitaxel in patients with … the treatment of advanced HR-positive breast cancer.
The drug was …
-
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
29 Apr 2025 16:33 GMT
… Virtue SAB in the Treatment of Coronary ISR Trial. The company plans … Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated … head-to-head trial with the commercially available Agent paclitaxel-coated balloon …
-
Orchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon
29 Apr 2025 13:00 GMT
… Treatment of Coronary ISR Trial (“Virtue Trial”). The IDE provides FDA … amp; Vascular Institute, Medical Director of The Christ … field largely reliant on paclitaxel drug-coated balloons, Virtue … drug-eluting stents. Published meta-analysis involving 76 trials …
-
Immune and Metabolic Reprogramming Induced by Paclitaxel, Capecitabine and Eribulin in Breast Cancer: Insights into Therapeutic Targets
28 Apr 2025 17:19 GMT
… their metabolic profiles and drug treatment. Volcano plots of … cholesterylesterases and phosphatidylcholines with Paclitaxel treatment (Figure 4C), only. … cancer: a randomized clinical trial. JAMA Oncol. 2020 … of in vitro cytotoxicity trials. Nutrients. 2023;15 …
-
Human medicines European public assessment report (EPAR): Dazublys, trastuzumab, Status: Opinion
28 Apr 2025 10:38 GMT
… authorisation for the medicinal product Dazublys, intended for the treatment of breast … (trastuzumab). More information on biosimilar medicines can be found here.
The … unsuitable for these treatments.
in combination with paclitaxel for the treatment of those …
-
KN026 Plus Chemo Improves PFS in Pretreated HER2+ Gastric/GEJ Cancer
01 May 2025 18:19 GMT
… Center for Drug Evaluation of the National Medical Products Administration … line therapy.
KN026-001 Trial Design
The randomized, multicenter, … experienced disease progression during treatment or within 6 months … in both arms included paclitaxel at 175 mg…
-
KEYTRUDA® (pembrolizumab) as Perioperative Treatment With Standard of Care (SOC) Adjuvant Therapy Significantly Improved Event-Free Survival Compared to SOC Alone in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
27 Apr 2025 16:10 GMT
… and Drug Administration (FDA), with a Prescription Drug User … infection. Institute medical management promptly, including … paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment … the impact of pharmaceutical industry regulation and …
-
Anlotinib Combo Improves PFS/OS in Extensive-Stage Small Cell Lung Cancer
30 Apr 2025 17:30 GMT
… Shanghai Pulmonary Hospital, School of Medicine, of Tongji University in … randomized clinical trials that evaluated patients with newly diagnosed treatment-naïve ES … CA184-156 trial (NCT01450761);
Concurrent or phased ipilimumab plus paclitaxel and …