Pharma News

Every day around 93% of the world’s children under the age of 15 years (1.8 billion children) breathe air that is so polluted it puts their health and development at serious risk. Tragically, many of them die: WHO estimates that in 2016, 600,000 children died from acute lower respiratory infections caused by polluted air.

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is pausing the CONCERT-HF trial, which involves patients with chronic heart failure. Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial. While none of the articles in question derive from the CONCERT-HF trial itself, the NHLBI convened CONCERT-HF’s Data and Safety Monitoring Board (DSMB) out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity. Informed by the DSMB recommendations of October 25, 2018, the NHLBI is pausing the trial. While the DSMB did not have any participant safety concerns, this pause enables the DSMB to complete its review.

US FDA has issued the final guidance for Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers1 for Human Use.

ISPE announced the release of their latest Guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts.  This publication provides detailed practical guidance to support data integrity within a regulated organization.

Countries around the world today agreed to the Declaration of Astana, vowing to strengthen their primary health care systems as an essential step toward achieving universal health coverage.

The Declaration of Astana reaffirms the historic 1978 Declaration of Alma-Ata, the first time world leaders committed to primary health care.

[adsense:336x280:8701650588]

U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

Thirteen researchers have been selected for the inaugural class of the National Institutes of Health’s Distinguished Scholars Program (DSP). The NIH-wide pilot program is designed to build diversity within the NIH Intramural Research Program, comprised of NIH scientists, by facilitating hiring and career progression of tenure-track investigators who have demonstrated a commitment to promoting diversity and inclusion in the biomedical research workforce.

U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status.

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.

U.S. Food and Drug Administration (FDA) approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).