Pharma News

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.

This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union.

U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students since last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.

EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

Eminence Business Media’s debut edition of “Improving Investigation Process & CAPA 2018” successfully concluded on October 11th & 12th, 2018, at Hotel Sahara Star, Mumbai.

A Memorandum of Understanding (MoU) for the partnership between Department of Biotechnology and Cancer Research UK for the India-UK India-UK Cancer Research Initiative was signed today in New Delhi.The India-UK Cancer Research Initiative is a collaborative 5-year bilateral research initiative by the Department of Biotechnology, Ministry of Science & Technology, India and Cancer Research UK (CRUK) that will focus on affordable approaches to cancer. Both CRUK and DBT will invest £5m each in this 5-year pilot, and seek further investment from other potential funding partners.

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The Health Ministry has taken up several focused and targeted schemes for addressing nutrition challenges in the country in a convergence mode with the other Ministries.We have focussed on Immunisation, detection and supplementation.  This was stated by Shri J P Nadda, Union Minister for Health and Family Welfare at the 3rd meeting of the “National Council on India’s Nutrition Challanges” in presence of Smt Maneka Sanjay Gandhi, Minister of Women and Child Development.

National Institutes of Health scientists and their collaborators found that hepatitis B virus (HBV)-associated acute liver failure (ALF) - a rare condition that can turn fatal within days without liver transplantation - results from an uncommon encounter between a highly mutated HBV variant and an unusual immune response in the patient’s liver that is mainly sustained by antibody-producing B cells. Their study is published in Proceedings of the National Academy of Sciences.

Antibiotic resistance is a growing threat to global health. As a result of infection with drug-resistant bacteria an estimated 700 000 people die each year worldwide. A total of around 33 000 die annually in the European Union and European Economic Area, and this number is increasing all the time.

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.