Pharma News

The U.S. Food and Drug Administration has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona, and its chief executive officer, David Greene, M.D. The company, through its affiliated centers or clinics throughout the U.S., offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS). The products offered by R3 Stem Cell, LLC are not approved by the FDA.

The FDA has notified each of R3 Stem Cell, LLC’s more than 50 affiliate centers or clinics of this action.

The latest Annual Report to the Nation on the Status of Cancer finds that, for all cancer sites combined, cancer death rates continued to decline in men, women, and children in the United States from 1999 to 2016. Overall cancer incidence rates, or rates of new cancers, decreased in men from 2008 to 2015, after increasing from 1999 to 2008, and were stable in women from 1999 to 2015. In a special section of the report, researchers looked at cancer rates and trends in adults ages 20 to 49.

Youth who said they were teased or ridiculed about their weight increased their body mass by 33% more each year, compared to a similar group who had not been teased, according to researchers at the National Institutes of Health. The findings appear to contradict the belief that such teasing might motivate youth to change their behavior and attempt to lose weight. The study was conducted by Natasha A. Schvey, Ph.D., of the Uniformed Services University of the Health Sciences in Bethesda, Maryland, and colleagues at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. It appears in Pediatric Obesity.

Novartis announced the US Food and Drug Administration (FDA) has approved Piqray (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

A protein from Simian Immunodeficiency Virus (SIV), which can infect monkeys and apes, has shown promise as a potential component of a vaccine against Human Immunodeficiency Virus (HIV), in a new study from scientists at Scripps Research in La Jolla, California.

Cardiologists know that familial hypercholesterolemia (FH), a condition that causes extremely high levels of cholesterol at an early age, is genetic. When one person is diagnosed, other family members can be identified. However, only an estimated 10 percent of those with FH are diagnosed, leaving many others at risk.

More than 20 million babies were born with a low birthweight (less than 2500g; 5.5 pounds) in 2015 - around one in seven of all births worldwide according to the first-ever estimates documenting this major health challenge.

After decades of ground-breaking laboratory works, the world’s scientific and technical community, in a landmark and historic decision taken in the recent open session of the General Conference on Weights and Measures (CGPM) at BIPM on 16 November 2018, has unanimously adopted the resolution to redefine four of the seven base units, the kilogram (SI unit of weight), Kelvin (SI unit of temperature), mole (SI unit of amount of substance), and ampere (SI unit of current). This decision has now enabled scientists and researchers to base the SI units entirely on fundamental properties of nature, which will ensure their ongoing refinement and improvement for years to come. The fundamental constants are invariants of time and space and successfully replaced the artifact based units, and aptly opened up the new era for quantum world by linking all seven base units to fundamental constants/quantum standards.

New clinical research supported by the National Institutes of Health shows that increasing the intensity of treatment for alcohol use disorder (AUD) over time improves alcohol-related outcomes among people with HIV. This stepped approach to AUD treatment also improves HIV-related disease measures in this patient population.  A report of the new study, led by researchers at Yale University, is now online in The Lancet HIV.