Pharma News

Novavax, Inc a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid  (NVX-CoV2373). This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19.

For the first time, scientists have shown that gut bacteria differences are associated with later development of juvenile idiopathic arthritis, a debilitating rheumatic childhood disease, and that these differences are present years before the disease is diagnosed.

The Pharmacy Council of India (PCI) has urged the Jharkhand government to recall its decision of granting permission for opening pharmacies in rural areas without registered pharmacists.

Older people who have fluctuating levels of cholesterol and triglycerides may have a higher risk of Alzheimer’s disease and related dementias compared to people who have steady levels, according to new research published in the July 5, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. While the study found a link, it does not prove that fluctuating levels of cholesterol and triglycerides cause dementia.

Nearly 700,000 people in the United States die from heart disease every year, and one-third of those deaths result from complications in the first weeks or months following a traumatic heart-related event.

U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education.

Eli Lilly and Company (NYSE: LLY) announced new phase 2 data from retatrutide, Lillys investigational molecule being studied for the treatment of obesity. At 24 weeks, retatrutide (1 mg, 4 mg, 8 mg or 12 mg) met the primary endpoint for the efficacy estimand in participants living with obesity or overweight without diabetes, demonstrating a mean weight reduction up to 17.5% (41.2 lb. or 18.7 kg)ii. In a secondary endpoint, retatrutide demonstrated a mean weight reduction up to 24.2% (57.8 lb. or 26.2 kg)ii at the end of the 48-week treatment duration.

U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

Clinicians have a new standard for graft-versus-host disease (GVHD) prevention after allogeneic hematopoietic stem cell transplantation, according to results from a phase III study published June 22 in the New England Journal of Medicine. The new standard is more effective at preventing GVHD and came with less side effects, compared with the current gold standard.