Pharma News

The U.S. Food and Drug Administration  authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS and is to be used along with the evaluation of a patient’s family history and clinical signs and symptoms of FXS. Additionally, this test is intended for use in adults who may be carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene.

Novartis announced the European Commission (EC) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity, versus aflibercept (secondary endpoints). Beovu also offers the ability to start eligible wet AMD patients on a three-month dosing interval immediately after the loading phase. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

The U.S. Food and Drug Administration announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.

Researchers at the National Institutes of Health found evidence that specific immune cells may play a key role in the devastating effects of cerebral malaria, a severe form of malaria that mainly affects young children. The results, published in the Journal of Clinical Investigation, suggest that drugs targeting T cells may be effective in treating the disease. The study was supported by the NIH Intramural Research Program.

Human milk oligosaccharides (HMOs) found in breastmilk may influence a child’s growth from infancy through early childhood, according to a study supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The study also suggested that maternal obesity may affect HMO composition in breastmilk. The study was led by Lars Bode, Ph.D., at the University of California, San Diego. It appears in The American Journal of Clinical Nutrition.

Favipiravir has shown potential in treating the novel coronavirus COVID-19. Drug Regulatory Body in China announced that they have approved clinical trials of the antiviral favilavir for use in the treatment of the novel coronavirus COVID-19, reported by UPI.

The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain;  Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use.

Leading health experts from around the world have been meeting at the World Health Organization’s Geneva headquarters to assess the current level of knowledge about the new COVID-19 disease, identify gaps and work together to accelerate and fund priority research needed to help stop this outbreak and prepare for any future outbreaks.

Following a review of the risk of meningioma (a rare tumour of the membranes covering the brain and spinal cord) in patients taking cyproterone, EMA’s safety committee (PRAC) has recommended that medicines containing 10 mg or more of cyproterone should only be used for hirsutism (excessive hair growth), androgenic alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed.

Less than one in four adolescent men who have sex with men (AMSM) ever get tested for HIV, research funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health, has reported. The study, led by Brian Mustanski, Ph.D., of Northwestern University, Chicago, IL, appeared today in the journal Pediatrics.