Industry News

U.S. Senator Orrin Hatch (R-Utah), Ranking Member of the Committee on Finance, today announced an amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, to repeal the job-killing medical device tax that was included in the $2.6 trillion health spending law enacted last year.

Berlin Packaging, a full-service supplier of plastic, glass, and metal containers and closures, was once again one of the top winners at the 2012 National Association of Container Distributors (NACD) Package Awards Competition, taking honors in multiple categories. The wins, which include designs for Mission Athletecare, Kremers Urban Pharmaceuticals, Ainsworth Pet Nutrition and IHOP (International House of Pancakes, LLC), build upon the company's 2011 showing when it won best in show honors for Pampers Kandoo hand soap, along with six other awards.

Auxilium Pharmaceuticals, Inc. and FCB I LLC announced today that they filed a lawsuit against Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; and Watson Pharma, Inc. (collectively, "Watson") for infringement of FCB's ten patents listed in the U.S. Food and Drug Administration's ("FDA's") Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the "Orange Book") as covering Testim 1% testosterone gel.  The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012.

Moog Medical Devices Group (MMDG) is issuing a voluntary recall for certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.

The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:

Today at the European Stroke Conference in Lisbon, Portugal, Stryker announced the results of the TREVO 2 clinical trial. The study met the primary effectiveness endpoint, with the Trevo Retriever achieving significantly better post-device revascularization than the Merci Retriever (86.4% in the Trevo Retriever arm compared to 60% in the Merci Retriever arm). The rates of functional independence at 90 days for patients treated with the Trevo Retriever were also better than for the Merci Retriever (40% mRS less than or equal to 2 compared to 21.8%).

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy.

New research sponsored by CVS Caremark examined the effects of Food and Drug Administration (FDA) drug warnings on medication adherence when the warnings are not delivered with clear clinical recommendations. The research found that immediately following a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription increased by nearly 6 percent.

Reportlinker.com announces that a new market research report is available in its catalog: Drug Price Cuts in Top Five Countries of Europe - Tougher Reference Pricing Environment and Drug Price Freeze through 2013 Expected to Drive Down Healthcare Costs.

TriReme Medical, Inc. (TMI) today announced approval by the U.S. Food and Drug Administration (FDA) of the Glider PTCA Catheter, indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion.
Glider is the world's only torqueable PTCA balloon catheter. Combined with its state of the art tip technology, Glider is designed to perform, even in the most challenging conditions. It is also available in an ultra short balloon length of 4mm designed for focal lesions.

The Blood Sugar Basics Game Plan, developed by the American College of Endocrinology (ACE), with support from Merck (NYSE:MRK) (known as MSD outside the United States and Canada), is kicking off to help the nearly 26 million people in the U.S. who have diabetes find new ways to help manage their disease. The interactive, user-friendly program breaks down diabetes management into four easy-to-understand "goals" to help people with type 2 diabetes take small steps toward better management of their disease.