Pharma News

U.S. Food and Drug Administration finalized its guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems (ENDS), such as e-cigarettes or “vapes,” and the liquid nicotine and nicotine-containing e-liquids used with such products, as part of the agency’s continued commitment to its oversight of tobacco products.

Emmanuel Macron, President of the French Republic and Dr Tedros Adhanom Ghebreyesus, WHO Director-General met at WHO Headquarters in Geneva.

They signed a Declaration of Intent to establish the WHO Academy that will revolutionize lifelong learning in health. The Academy aims to reach millions of people with innovative learning via a state-of-the-art digital learning experience platform at a campus in Lyon and embedded in the six WHO regions. The WHO Academy Lyon hub will feature high-tech learning environments, a world-class health emergencies simulation center and collaboration spaces for learning co-design, research and innovation.

Luxembourg and the Netherlands were included into the mutual recognition agreementbetween the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 26 Member States whose inspection results can replace their own inspections.

The U.S. Food and Drug Administration  approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.

A class of immune cells called innate lymphoid cells (ILCs) mediates the body’s initial defense against tuberculosis (TB), according to a report published online today in Nature. Boosting this response may provide a new approach to developing treatments and vaccines against TB, which causes more deaths worldwide than any other single infectious disease. The research was supported in part by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health.  It was conducted by scientists at Washington University School of Medicine in St. Louis in collaboration with scientists at the Africa Health Research Institute in KwaZulu-Natal, South Africa, and other institutions.

The Competition Commission of India (‘Commission’) has found Madhya Pradesh Chemists and Druggist Association (‘MPCDA’), Indore Chemists Association (‘ICA’), Himalaya Drug Company (‘HDC’) and Intas Pharmaceuticals Limited (‘IPL’) along with some of their office bearers/officials to be in contravention of the provisions of the Competition Act, 2002 (‘Act’).

Researchers at the Department of Biosciences, Jamia Millia Islamia (JMI) have tested a formulation combining silver nonoparticles with Ampicillin, one of the early antibiotics, that can kill antibiotic-resistant bacteria, a major threat to public health, effectively.

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.