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Cubist enters license agreement with Teva to dismiss CUBICIN patent lawsuit

Cubist Pharmaceuticals, Inc. today announced that it has entered into a license agreement with Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., which includes a stipulation by the parties requesting dismissal of the lawsuit filed by Cubist in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by TPM with the U.S. Food and Drug Administration for a generic version of CUBICIN.

5 Apr 2011

Food addicts appear to have high neural activity in brain

Persons with an addictive-like eating behavior appear to have greater neural activity in certain regions of the brain similar to substance dependence, including elevated activation in reward circuitry in response to food cues, according to a report posted online today that will appear in the August print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

5 Apr 2011

Positive outcomes from Medtronic's Resolute drug-eluting stent against coronary artery disease

Results of two major clinical studies presented at ACC.11 - the 60th Annual Scientific Session & Expo of the American College of Cardiology - demonstrate that the Resolute drug-eluting stent from Medtronic, Inc., provides a positive and persistent treatment effect for a wide variety of patients with coronary artery disease.

5 Apr 2011

Diets may cause loss of lean muscle mass

According to boomer-generation brother and sister authors Dian Griesel, Ph.D. and Tom Griesel, every well-known diet to date is destined to deliver loss of lean muscle mass, moodiness, disappointment and failure.

5 Apr 2011

CryoLife files PerClot IDE with FDA to initiate clinical trials in the U.S.

CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced today that it has filed an IDE with the United States Food and Drug Administration to begin clinical trials for the purpose of obtaining Pre-Market Approval to distribute PerClot in the U.S. to control bleeding during surgical procedures or following traumatic injuries.

5 Apr 2011

Opinions: Africa's agricultural sector; foreign aid funding

"There is no doubt that Africa is on the move … But if African countries are to achieve the new future within their grasp, then there needs to be a new focus on the daunting obstacles still to be overcome. … High among these challenges is the need to transform the continent's agriculture," former U.N. Secretary-General Kofi Annan writes in a BusinessDay opinion piece reflecting on the challenges facing Africa's agricultural system and the opportunities to respond to the growing food demands.

5 Apr 2011

Boehringer Ingelheim receives FDA approval for Viramune XR to treat HIV-1 infection

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Viramune XR extended-release tablets, a one-pill, once-daily formulation of nevirapine for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

5 Apr 2011

Medical industry veteran set to play key role as Microvisk gears up to launch Smartstrip®

Microvisk Technologies, the developer of a handheld system to monitor the blood clotting status of patients taking the drug Warfarin, today announced that it has strengthened its Board with the appointment of medical industry veteran, Bill Moffitt, as Chairman and Peter Whitehouse as CFO.

4 Apr 2011

Hospira seeks FDA 510(k) clearance for Symbiq infusion system modifications

Hospira, Inc., a leading provider of clinical information and medication delivery technologies, today announced that the company has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for modifications to the Symbiq™ infusion system. The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.

4 Apr 2011

FDA approves St. Jude Medical's Safire BLU and Therapy Cool Path irrigated ablation catheters

St. Jude Medical, Inc., a global medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) approval of two new irrigated ablation catheters - the Safire BLU™ Bi-directional Irrigated Ablation Catheter and the Therapy™ Cool Path™ bi-directional ablation catheter.

4 Apr 2011

Pfizer receives FDA Refusal to File letter for tafamidis to treat Transthyretin Familial Amyloid Polyneuropathy

Pfizer Inc. announced today that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for tafamidis, the company's novel, oral investigational compound for patients with Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).

4 Apr 2011

Orexo partner ProStrakan launches Abstral in the US

Orexo AB announces today that its partner ProStrakan Group plc has launched Abstral in the United States.

4 Apr 2011

Mylan receives FDA approval for generic Xalatan Ophthalmic Solution

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Latanoprost Ophthalmic Solution, 0.005%, the generic version of Pharmacia and Upjohn's Xalatan® Ophthalmic Solution, an eyedrop that lowers pressure in the eye.

4 Apr 2011

Avanir files IND for NUEDEXTA/AVP-923 Phase II clinical trial for central neuropathic pain in MS patients

Avanir Pharmaceuticals, Inc. today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). The FDA has acknowledged receipt of the submission and the company expects that the IND filing will be subject to standard 30-day review.

4 Apr 2011

First Edition: April 4, 2011

Today's health policy news coverage includes reports about Republican lawmakers' plans to make dramatic changes to Medicare and Medicaid as they seek to cut $4 trillion from the budget over the next 10 years.

4 Apr 2011

FDA releases rules for restaurants to provide calorie information

The federal government on Friday released proposed rules requiring chain restaurants and other businesses that serve food to post calorie counts on menus and menu boards. But after objections from theater chains, the rules give a pass to those box-office snacks — even though a large popcorn and soda can contain as many calories as a typical person needs in a day.

4 Apr 2011

Life Technologies launches new TaqMan Mutation Detection Assays

Life Technologies Corporation today announced the launch of its TaqMan Mutation Detection Assays -- highly sensitive and novel molecular analysis research tools with the precision to detect a single mutant molecule hiding in a background of 1 million normal copies.

4 Apr 2011

Study: Nanoparticles can prevent nickel-induced dermatitis

Tiny particles only billionths of a meter in diameter-about two thousand would fit across the width of a human hair-could offer big hope in a small package to the many millions of people who are allergic to the nickel in everything from jewelry to coins and cell phones, say scientists at Brigham and Women's Hospital.

4 Apr 2011

QIAGEN to acquire Cellestis

QIAGEN N.V. has reached an agreement to acquire Cellestis Limited for approximately A$341 million in cash, providing QIAGEN with access to a novel "pre-molecular" technology that offers a new dimension in disease detection not currently possible with other diagnostic methods.

From QIAGEN Manchester Limited 4 Apr 2011

New heart valve procedure helpful for the elderly: Study

Researchers revealed this Sunday a new heart valve that can be implanted without surgery. The device may hold promise for tens of thousands of elderly patients who might not survive a standard valve-replacement operation.

3 Apr 2011