Pharma News

Sanofi and Regeneron Pharmaceuticals, Inc. announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also met a key secondary endpoint, demonstrating REGN3500 monotherapy significantly improved lung function compared to placebo.

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. already has one of the most effective and efficient generic markets in the world. Generic drugs represented 90% of U.S. prescriptions dispensed in 2017, and the FDA approved or tentatively approved more than 2,000 generic drug applications in 2017 and 2018 alone. But, there is more we may be able to do to facilitate a stable, competitive market.

WHO  launched a global campaign urging governments to adopt a tool to reduce the spread of antimicrobial resistance, adverse events and costs.

The AWaRe tool was developed by the WHO Essential Medicines List to contain rising resistance and make antibiotic use safer and more effective. It classifies antibiotics into three groups – Access, Watch and Reserve – and specifies which antibiotics to use for the most common and serious infections, which ones should be available at all times in the healthcare system, and those that must be used sparingly or preserved and used only as a last resort.

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’).