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FDA approves DuraSeal spine sealant for the U.S. market

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal™ spine sealant for use in the United States.

8 Sep 2009

BioTrove partners with FDA to investigate the utility of SNAP system

BioTrove announced a collaboration with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research to investigate the utility of the company’s Standardized NanoArray PCR (SNAP) gene expression profiling system for the rapid and specific detection of pathogens in the nation’s blood supply.

8 Sep 2009

Lupus Foundation of America takes steps to address shortage of participants for clinical trial

It has been more than 50 years since the U.S. Food and Drug Administration (FDA) last approved a new medicine specifically for lupus – when Dwight D. Eisenhower was president. Existing treatments have been "borrowed" from other disorders and the risk/benefit ratio of these treatments is far from optimal. However, hope is on the horizon.

8 Sep 2009

Aquaculture supplies half of the total fish and shellfish for human consumption

Aquaculture, once a fledgling industry, now accounts for 50 percent of the fish consumed globally, according to a new report by an international team of researchers. And while the industry is more efficient than ever, it is also putting a significant strain on marine resources by consuming large amounts of feed made from wild fish harvested from the sea, the authors conclude.

8 Sep 2009

IRS1 gene could lead to better treatment of type 2 diabetes

A breakthrough by an international team of researchers in Canada, France, the UK and Denmark has uncovered a new gene that could lead to better treatment of type 2 diabetes, as well as a better understanding of how this widespread disease develops.

7 Sep 2009

Opinion: Local drug production in developing countries; Obama's PEPFAR changes

The international community focuses on lowering drug prices as a means of improving access and "today its idea is local pharmaceutical production .

5 Sep 2009

Study calls for compelling messages to induce washing of hands

"Many students say they routinely wash their hands," said Douglas Powell, an associate professor of food safety at Kansas State University. "But even in an outbreak situation, many students simply don't."

5 Sep 2009

Increased consumer preference of walnut due to its alpha-linolenic acid content

The 2009 walnut harvest, currently underway in the California Central Valley, is estimated to be 415,000 short tons according to USDA NASS California Field Office estimates, a number which will be confirmed in February 2010. Overall, the California walnut crop has increased by 74% since 2000, though the current estimate is 4.4% lighter than last year's record crop of 434,301 short tons.

5 Sep 2009

Sinovac to purchase H1N1 vaccine for the national stockpiling plan

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the Ministry of Industry and Information Technology of the People's Republic of China has issued the initial order to Sinovac to purchase H1N1 vaccine for the national stockpiling plan.

5 Sep 2009

FDA notifies PDUFA action date for Cell Therapeutics' NDA for pixantrone

Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

5 Sep 2009

Spectrum's ZEVALIN expanded label receives FDA approval for treating non-Hodgkin’s Lymphoma

Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (FDA) for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.

5 Sep 2009

College students need a variety of messages to practice good hand hygiene

The path to poor hand sanitation is paved with good intentions, according to researchers from Kansas State and North Carolina State Universities.

5 Sep 2009

Delcath Systems to present abstract at ILCA Annual Conference

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that Dr. James F. Pingpank, Associate Professor of Surgery for the University of Pittsburgh School of Medicine will present an abstract at the International Liver Cancer Association's (ILCA) Third Annual Conference on Saturday, September 5, 2009 in Milan, Italy.

4 Sep 2009

AARP/Blue Zones Vitality Project launches "6 Weeks to Longevity" program

People don't want to just live longer; they want to live healthier and more purposeful lives. Now, through the AARP(R)/Blue Zones(R) Vitality Project sponsored by United Health Foundation, people from across America will have the opportunity to add healthy years to their lives by joining the project at AARP.org/BlueZonesProject and signing up for the "6 Weeks to Longevity," which kicks off on September 8, 2009.

4 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

R'09 Conference to be held for improving the material usage and energy efficiency

Everyone will be thinking about energy efficiency and resource management in Davos from the 14th to the 16th September. The primary aim of the R'09 Conference, now being held for the ninth time, is to improve the material usage and energy efficiency of manufactured products, services and processes, whether during the production, usage or even the recycling phases.

4 Sep 2009

Filing and review of belatacept's license application accepted by the FDA

Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company’s submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.

4 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

South Dakota Biotech Association to present the 4th Annual South Dakota Biotechnology Summit

Investing in Biotechnology for Life, Food and Energy,” is the theme for the 4th Annual South Dakota Biotechnology Summit and Annual Meeting on Thursday, September 17, 2009. This annual event is presented by the South Dakota Biotech Association and will be held at the Ramkota Hotel, Rushmore Room in Sioux Falls, SD.

4 Sep 2009