Agency and European Member States prepare for fundamental changes in pharmaceutical legislation The European Medicines Agency, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the [...]

Boston, MA — Limiting certain essential nutrients for several days before surgery—either protein or amino acids—may reduce the risk of serious surgical complications such as heart attack or stroke, according to a new Harvard School of Public Health (HSPH) study. The study appears in the January 25, 2012 issue of Science Translational Medicine. “Food restriction [...]

NEW YORK–Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). This submission was based on efficacy and safety data from Study 200, [...]

LONDON—Today, 13 pharmaceutical companies, the U.S., U.K. and U.A.E governments, the Bill & Melinda Gates Foundation, the World Bank and other global health organisations announced a new, coordinated push to accelerate progress toward eliminating or controlling 10 neglected tropical diseases (NTDs) by the end of the decade. Uniting efforts with NTD-endemic countries, partners pledged to [...]

NEW YORK–Pfizer Inc. today issued the following statement regarding the voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol): “We have announced a voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States. “We understand that this news can be very concerning and confusing [...]

GlaxoSmithKline (GSK) today announced it has joined other global pharmaceutical companies and leading organisations including the World Health Organization (WHO), the Bill & Melinda Gates Foundation, the UK Department for International Development and the US Agency for International Development (USAID) in a new united effort to support developing countries to defeat neglected tropical diseases (NTDs). [...]

The European Food Safety Authority (EFSA) has played a key role in European Union (EU) risk assessment regarding food and feed safety since 2002. EFSA is striving towards excellence and is recognised as the European reference body for risk assessment on food and feed, nutrition, animal and plant health. During its 10th anniversary year, EFSA [...]

January 23, 2012 – University Place, Washington- Jones’ Seasoning Blends LLC announced a voluntary recall of Jones’ Mock Salt Original as well as Jones’ Mock Salt Spicy Southwest Blend due to the potential contamination of Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, [...]

M.E. Thompson, Inc. of Jacksonville, FL is recalling its Anytime Deli Turkey & Ham Sub Sandwich, UPC 0543200194, with an expiration date of January 19th and January 22nd because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly [...]

WASHINGTON, – J&B Group, Inc., a St. Michael, Minn., establishment, is recalling approximately 2,645 pounds of beef sirloin products because the products are misbranded and contain an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen, which is not noted on the [...]