Pharma News

The health authorities in the Democratic Republic of the Congo (DRC) have announced plans to introduce a second experimental Ebola vaccine, manufactured by Johnson & Johnson, from mid- October.

This vaccine, which is given as a 2-dose course, 56 days apart, will be provided under approved protocols to targeted at-risk populations in areas that do not have active Ebola transmission as an additional tool to extend protection against the virus.

United Nations General Assembly, 12 multilateral agencies launched a joint plan to better support countries over the next 10 years to accelerate progress towards the health-related Sustainable Development Goals (SDGs).

Developed over 18 months, Stronger Collaboration, Better Health: Global Action Plan for Healthy Lives and Well-being for All outlines how a dozen multilateral health, development and humanitarian agencies will collaborate to be more efficient and provide more streamlined support to countries to deliver universal health coverage and achieve the health-related SDG targets.

Glenmark Pharmaceuticals Ltd., a research-led, integrated global pharmaceutical company, today announced that it has received approval from the Ministry of Healthcare, Russia to market Montlezir (Levocetirizine Dihydrochloride 5mg + Montelukast Sodium 10mg) film-coated tablets as a prescription product for the treatment of seasonal and perennial allergic rhinitis in patients above 15 years of age. Montlezir is expected to be available in the Russian market in Q3 FY 2019-20.

The U.S. Food and Drug Administration expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.

Marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit a variation to change the names of liposomal medicines, but only if there is a high risk of medication errors which would raise concerns regarding the safe use of the medicinal product.

EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.
Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

The National Institutes of Health has awarded approximately $35 million in new grants in fiscal year (FY) 2019 to advance research on Down syndrome through the Investigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome (INCLUDE) project. These awards bolster total funding for Down syndrome research in FY 2019 to an estimated $77 million.