Clinical Intelligence

Stratasys opens enrollment is 3DHEART pediatric clinical study

Wednesday, March 8, 2017

Stratasys, a 3D printing and additive manufacturing solutions company, announced enrollment is now open for 3DHEART, an investigator initiated trial. 3DHEART, which stands for 3DHearts Enabling A Randomized Trial, is a randomized, single-blind clinical trial to study the use of patient-specific 3D printed models in pre-operative planning for pediatric heart surgery. Stratasys is providing in-kind support with printing of the models to be used in the trial.

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Merck, Pfizer announce FDA and EMA filing acceptances of three marketing applications

Wednesday, March 8, 2017

Merck, known as MSD outside the U.S. and Canada, and Pfizer, have announced that the FDA has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and JANUVIA (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin. The Prescription Drug User Fee Act (PDUFA) action date from the FDA is in December 2017 for the three NDAs.

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Karyopharm announces results from interim analysis of phase II SOPRA study

Friday, March 3, 2017

Karyopharm Therapeutics, a clinical-stage pharmaceutical company, has announced the results of a planned interim analysis of the phase II SOPRA study evaluating single agent selinexor in relapsed/refractory acute myeloid leukemia (AML). The company determined in concert with the study’s independent Data Safety Monitoring Board (DSMB) that SOPRA will not reach statistical significance for overall survival (OS), the study’s primary endpoint.

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Johns Hopkins, MSCRF, BioCardia treat first patient with CardiAMP in ischemic heart failure trial

Wednesday, March 1, 2017

Johns Hopkins Medicine, the Maryland Stem Cell Research Fund (MSCRF) and BioCardia announced that the first patient has been treated in the pivotal phase III CardiAMP clinical trial of a cell-based therapy for the treatment of ischemic heart failure that develops after a heart attack. The first patient was treated at Johns Hopkins Hospital by a team led by Peter Johnston, M.D., a faculty member in the Department of Medicine and Division of Cardiology, and principal investigator of the trial at Johns Hopkins.

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Tocagen receives FDA Breakthrough designation for glioma

Friday, February 24, 2017

Tocagen, a clinical-stage, cancer-selective gene therapy company, has announced the FDA granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). Toca 511 & Toca FC is currently under evaluation in an international, randomized phase II/III clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment in the phase II portion of the trial has completed and top-line results are anticipated in the first half of 2018.

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