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Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).

22 Dec 2010

Delcath completes NDA submission for chemosaturation system

Delcath Systems, Inc. today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.

22 Dec 2010

First Edition: December 22, 2010

Today's headlines include a number of reports regarding a new proposed rule by the Department of Health and Human Services that will require insurers to justify large premium hikes.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Global Business Forum on health care at University of Miami

The University of Miami will bring together some of the most influential leaders in business and government, along with hundreds of professionals from across industries, Jan. 12 - 14, 2011 for a Global Business Forum entitled "The Business of Health Care: Defining the Future."

22 Dec 2010

Top ten advances in cardiovascular, stroke research in 2010

Research on reducing risks, improving medical treatment and improving lifestyle behaviors to fight the battle against heart disease and stroke are among the key scientific findings that make up this year's top cardiovascular and stroke research recognized by the American Heart Association/American Stroke Association.

22 Dec 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Intellipharmaceutics International, today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, for its application to market a generic of Wyeth's Protonix® tablets.

22 Dec 2010

Understanding partners' shopping behavior can help relieve stress at stores

The last-minute holiday dash is on: Men tend to rush in for their prized item, pay, and leave. Women study the fabrics, color, texture and price. The hunting and gathering ritual of yesteryear continues today in malls around the world. Understanding the shopping behavior of your partner can help relieve stress at the stores, according to a researcher at the University of Michigan.

22 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Healthy foods improve survival and quality of life in older adult population

In a study published in the January 2011 issue of the Journal of the American Dietetic Association, researchers investigated empirical data regarding the associations of dietary patterns with mortality through analysis of the eating patterns of over 2500 adults between the ages of 70 and 79 over a ten-year period.

22 Dec 2010

Congress poised to approve food safety legislation; 9/11 bill triggers criticsm of some GOP lawmakers

As Capitol Hill lawmakers continue working through the lame duck Congress, some Republicans are facing criticism for opposing the Sept. 11 responders bill. Meanwhile, legislators are poised to pass an overhaul to the nation's food safety system.

22 Dec 2010

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

The Coalition for Pulmonary Fibrosis announced to more than 128,000 patients news that the first drug for the treatment of the deadly lung disease Pulmonary Fibrosis has passed a major hurdle in the European regulatory process and is likely to be approved in all 27 member countries of the European Union.

22 Dec 2010

Nature News explores developing countries' commitment to R&D

Nature News explores how a report published last week by the Organisation for Economic Co-operation and Development (OECD) documents the growing commitment of several developing countries to R&D (Casassus, 12/20).

22 Dec 2010

Vitrolife receives FDA approval for RapitVit Blast and RapidWarm Blast vitrification products

Vitrolife has received approval from the U.S. Food and Drug Administration, FDA, the equivalent of the Swedish Medical Products Agency, for the products RapitVit™ Blast and RapidWarm™ Blast. So-called 510(k) clearance has been obtained for these products, which are used for so-called vitrification, the rapid freezing and thawing of blastocysts (embryos days 5-7 after fertilization). Vitrolife has since before approved products for vitrification of embryos in an earlier stage of the fertilization (embryos day 2-3 after fertilization).

22 Dec 2010

Arrow announces worldwide voluntary recall of 5800 Series IABs with Super Arrow-Flex Sheath Introducer

Arrow International has announced a worldwide voluntary recall of its 5800 Series IABs with Super Arrow-Flex Sheath Introducer. This recall is being conducted because of an increase of "stuck in sheath" reports involving the use of the Super Arrow-Flex Sheath with 5800 Series IAB products. When the IAB becomes stuck in sheath, the user is unable to move the IAB catheter forward or backward, potentially causing a delay in critical therapy.

22 Dec 2010

MiMedx to acquire Surgical Biologics

MiMedx Group, Inc., an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has signed a definitive agreement to acquire Surgical Biologics, a leader in the development of tissue processing techniques for creating implants for a variety of surgical indications from amnion membranes.

22 Dec 2010

Mesa Labs announces acquisition of Apex's biological indicators business

Mesa Laboratories, Inc., a Lakewood, Colorado based manufacturer of electronic instruments and disposables today announced the acquisition of the biological indicators business of Apex Laboratories, Inc., a North Carolina based company. The acquisition of the Apex business is expected to be immediately accretive to Mesa's earnings per share.

22 Dec 2010

Spirulina dietary supplement may provide clinical benefits for ALS patients

Nutritional supplementation with Spirulina, a nutrient-rich, blue-green algae, appeared to provide neuroprotective support for dying motor neurons in a mouse model of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, University of South Florida neuroscientists have found.

21 Dec 2010

FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

An estimated 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) - a dangerous bulge or ballooning in their bodies' main artery that typically causes no symptoms until it ruptures, which can be deadly - and most of them don't know it. But for those with a known AAA of a certain size, there's a new medical device for a safe and effective treatment option that doesn't require major surgery, an extended hospital stay and a long recovery period.

21 Dec 2010

Food News and Research

Arena, Eisai complete lorcaserin NDA end-of-review meeting with FDA

Delcath completes NDA submission for chemosaturation system

First Edition: December 22, 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Global Business Forum on health care at University of Miami

Top ten advances in cardiovascular, stroke research in 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Understanding partners' shopping behavior can help relieve stress at stores

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Healthy foods improve survival and quality of life in older adult population

Congress poised to approve food safety legislation; 9/11 bill triggers criticsm of some GOP lawmakers

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

Nature News explores developing countries' commitment to R&D

Vitrolife receives FDA approval for RapitVit Blast and RapidWarm Blast vitrification products

Arrow announces worldwide voluntary recall of 5800 Series IABs with Super Arrow-Flex Sheath Introducer

MiMedx to acquire Surgical Biologics

Mesa Labs announces acquisition of Apex's biological indicators business

Spirulina dietary supplement may provide clinical benefits for ALS patients

FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

Understanding cultivated meat and its global potential eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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