Pharma News

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.

The task force  set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortage. Improving the availability of human and veterinary medicines authorised in the EU is a key concern.  The task force will develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.

Adverum Biotechnologies, Inc a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).