XTalks

MARCH 30, 2021

Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a press announcement from the agency. The first study was a randomized, double-blind, controlled trial consisting of 20 MS patients with gait deficits.

Radiology 71

Radiology Trials Marketing Containment 71

XTalks

APRIL 6, 2021

It is based on the FDA’s determination that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s). The Harmony pulmonary valve is implanted using a thin catheter with a collapsed Harmony valve on the end.

FDA Approval 98

FDA Approval Radiology Containment Clinical Trials 98

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . PLYMOUTH MEETING, Pa. ,

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

DECEMBER 9, 2020

. “Of all the organs in our body, the brain is the one most easily damaged by a poor diet,” said Dr. Lisa Mosconi, director of the Women’s Brain Initiative and an associate professor of neuroscience in neurology and radiology at Weill Cornell Medicine and NewYork-Presbyterian Hospital.

Radiology 52

Radiology Research Containment Medicine 52

The Pharma Data

OCTOBER 14, 2020

Felker’s research focus is on clinical trials in acute and chronic heart failure and the use of biomarkers as diagnostics, prognostic, and therapeutic tools in heart failure. Udelson, MD is Chief of the Division of Cardiology at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine.

Cardiology 40

Cardiology Clinical Trials Clinical Trials Medicine 40

The Pharma Data

DECEMBER 8, 2020

Under the Orphan Drug Act, FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by FDA.

Drugs 40

Drugs FDA Approval Marketing Containment 40

The Pharma Data

AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. WELIREG is the first HIF-2? of patients.

Hormones 52

Hormones Clinical Trials Clinical Trials Trials 52

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Novavax has also tested its recombinant SARS-CoV-2 nanoparticle adjuvanted vaccine in a Phase I/II trial.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92