Pharma News

“India has fast-tracked many initiatives aimed at achieving all the core tenets of Universal Health Coverage i.e, strengthening health systems, improving access to free medicines & diagnostics and reducing catastrophic healthcare spending.” This was stated by Shri J P Nadda, Union Minister of Health and Family Welfare at the inauguration of  the ‘71st Session of the WHO Regional Committee for South-East Asia.

U.S. Food and Drug Administration announced its new export certification program for certain FDA-regulated food products and fees it will assess for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides U.S. exporters another tool to facilitate exports to countries that import food products from the U.S.

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.

Results from a clinical trial of more than 250 participants with progressive multiple sclerosis (MS) revealed that ibudilast was better than a placebo in slowing down brain shrinkage. The study also showed that the main side effects of ibudilast were gastrointestinal and headaches.  The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, and published in the New England Journal of Medicine.

Reflecting its uncompromising commitment to patient safety, Alcon  announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market.

A new study showed that a change in the type of breathing tube paramedics use to resuscitate patients with sudden cardiac arrest can significantly improve the odds of survival and save thousands of lives. More than 90 percent of Americans who experience sudden cardiac arrest die before, or soon after, reaching a hospital.

It is well known that pharma companies are ready to chip on shoulders with rival companies in any regulatory or marketing disputes. Recently pfizer has took a dig against Amgen, Johnson & Johnson and Genentech for allegedly distribiting false and misleading information about use of biosimilars in the U.S. Pfizer filed citizen petition and requested FDA that they should issue guidance to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics.

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Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the U.S. Food and Drug Administration. Consumers deserve accurate information about the food they eat and how it can affect their health and nutrition. That’s why Congress entrusted the FDA to serve as the nation’s expert on food safety and labeling and to craft predictable, uniform federal requirements on matters within our jurisdiction. Consistent with that authority, we work to provide the best advice possible to Americans about the foods they eat based on the most recent scientific information, taking into account the food’s benefits in addition to any potential health risks.

The U.S. Food and Drug Administration announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.

Children react differently to medicines than adults, which is why it is important that medicines are properly studied and demonstrated to be safe and effective for minors.