Pharma News

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

  • Posted on: 25 February 2020
  • By: Shalini.Sharma

U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.

Maternal obesity linked to ADHD and behavioral problems in children, NIH study suggests

  • Posted on: 25 February 2020
  • By: Shalini.Sharma

Maternal obesity may increase a child’s risk for attention-deficit hyperactivity disorder (ADHD), according to an analysis by researchers from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The researchers found that mothers - but not fathers - who were overweight or obese before pregnancy were more likely to report that their children had been diagnosed with attention-deficit hyperactivity disorder (ADHD) or to have symptoms of hyperactivity, inattentiveness or impulsiveness at ages 7 to 8 years old. Their study appears in The Journal of Pediatrics.

FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

  • Posted on: 25 February 2020
  • By: Shalini.Sharma

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 receives European Commission Approval for Beovu (brolucizumab) for the treatment of wet age-related macular degeneration

  • Posted on: 25 February 2020
  • By: PharmaTutor News

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.

FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

  • Posted on: 20 February 2020
  • By: Shalini.Sharma

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.

NIH study supports new approach for treating cerebral malaria

  • Posted on: 20 February 2020
  • By: Shalini.Sharma

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.

NIH-funded study links natural sugars in breastmilk to early childhood height and weight

  • Posted on: 20 February 2020
  • By: Shalini.Sharma

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.

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

  • Posted on: 18 February 2020
  • By: Shalini.Sharma

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.

World experts and funders set priorities for COVID-19 research

  • Posted on: 18 February 2020
  • By: Shalini.Sharma

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.

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