Pharma News

U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities.

An analysis of a previous study has found more evidence to support giving the steroid betamethasone to pregnant women at risk of late-preterm delivery (between 34 and 36 weeks of gestation), according to a network funded by the National Institutes of Health. Hospital stays for infants whose mothers received the drug cost less on average, compared to stays for infants whose mothers did not take the drug. The study appears in JAMA Pediatrics.

The National Institutes of Health has selected eight scientists as Lasker Clinical Research Scholars, part of a joint initiative with the Albert and Mary Lasker Foundation, to foster the next generation of great clinical scientists. This highly competitive program provides talented, early stage researchers the opportunity to carry out independent clinical and translational research for five to seven years at NIH.

EMA left its London premises on March 1, and following a transitional week of teleworking, its staff will gradually move throughout this week into the Spark building in Amsterdam Sloterdijk.

Advancements in the dynamic field of biotechnology are bringing about the development of innovative, new food products. At the U.S. Food and Drug Administration, we’re committed to helping food developers bring biotechnology innovations to market while at the same time providing consumers with confidence that foods available for purchase in the U.S. – whether developed using traditional breeding techniques or biotechnology – meet the FDA’s high safety standards.

A new study finds vitamin D may be protective among asthmatic obese children living in urban environments with high indoor air pollution. The study out of John Hopkins University School of Medicine, funded by the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health, was published in The Journal of Allergy and Clinical Immunology: In Practice.

U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples common devices used in many surgeries and to provide updated recommendations to help reduce risks associated with their use.

Since the biosimilar pathway was established in 2010, there’s been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance. Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition.

Eighty-six percent of individuals who entered HIV care soon after diagnosis maintained viral suppression after 48 weeks during a clinical trial conducted at four National Institutes of Health-funded Centers for AIDS Research (CFARs) across the United States. Participants in the clinical trial, called iENGAGE, achieved viral suppression in an average of just 63 days. The findings were presented in a poster at the Conference on Retroviruses and Opportunistic Infections(link is external) (CROI 2019) in Seattle.