Pharma News

Four new grants will help to move scientific discoveries and technologies out of the lab and into commercial products that improve patient care and enhance human health. Awards for Regional Technology Transfer Accelerator Hubs for Institutional Development Award (IDeA) states will total almost $2 million in the first year and potentially more than $13 million over three years, pending the availability of funds.

The countries of WHO’s Eastern Mediterranean Region signed a UHC2030 Global Compact during the “Ministerial meeting on the road towards universal health coverage” taking place in Salalah, Oman, from 3 to 5 September 2018. Ministers of health and heads of delegations collectively approved the landmark document, making the Region the first among WHO’s 6 regions to do so.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

“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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