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Experimental vaccine protects mice and monkeys against chikungunya virus

An experimental vaccine developed using non-infectious virus-like particles (VLP) has protected macaques and mice against chikungunya virus, a mosquito-borne pathogen that has infected millions of people in Africa and Asia and causes debilitating pain, researchers at the National Institutes of Health have found.

29 Jan 2010

QIAGEN hosts panel discussion to educate public about the emerging promise of personalized medicine

The treatment of illness has traditionally been based on the law of averages – what works best for the largest number of patients. As a result, billions of dollars are spent every year on treatments that could be ineffective or even harmful for some patients. What if doctors could tell with a simple test which course of treatment would be best for a particular patient?

From QIAGEN Manchester Limited 29 Jan 2010

Health benefits of aerobics can be greatly affected by what you eat after exercise

Many of the health benefits of aerobic exercise are due to the most recent exercise session (rather than weeks, months and even years of exercise training), and the nature of these benefits can be greatly affected by the food we eat afterwards, according to a study published in the Journal of Applied Physiology (http://jap.physiology.org).

29 Jan 2010

AMP releases new position statement on the oversight of LDTs

Today, the Association for Molecular Pathology (AMP) released its new position statement on the oversight of laboratory developed tests (LDTs), a recent focus of debate among policy makers, the laboratory community and other stakeholders.

29 Jan 2010

Ongoing parenting is necessary to improve children's food choices

Many parents become passive when it comes to their children's food choices. The growing epidemic of obesity in America is a strong indicator of this lapse in parenting. With the variety of resources available from the USDA My Pyramid program to local schools' curriculums, Dr. Sasson ("Dr. Sass") Moulavi, M.D., is surprised by parents' neglect when it comes to allowing poor food choices for children.

29 Jan 2010

Labeling update for Tibotec Therapeutics' PREZISTA tablets approved

Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for PREZISTA® (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies.

29 Jan 2010

Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA’s pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in Ampyra™.

29 Jan 2010

FDA approves LPI's Perindopril Erbumine tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Perindopril Erbumine tablets, 2mg, 4mg and 8mg. Commercial shipments of the product will commence shortly.

29 Jan 2010

NovaSom Diagnostic System approved for diagnostic evaluation of adults with OSA

Some 18-20 million Americans are at risk for Obstructive Sleep Apnea (OSA) and of those, only 5 to 10 percent have been diagnosed. Studies prove that fatality is a major risk of undiagnosed and untreated OSA; however, once detected, OSA can be readily and successfully treated.

29 Jan 2010

FDA cautions drug makers about potential abuse

The Los Angeles Times reports that the Food and Drug Administration "this week released a draft of voluntary guidelines to assist drug makers in figuring out which compounds should be placed under the Controlled Substances Act. The law regulates the handling, record-keeping and dispensing of drugs deemed to be dangerous or addictive if misused -- in some cases imposing criminal penalties for misuse.

28 Jan 2010

Aubrey receives FDA clearance to market bioengineered wound dressings in U.S.

Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States.

28 Jan 2010

Zelos Therapeutics commences dosing in clinical study of ZT-034 nasal spray for osteoporosis

Zelos Therapeutics, Inc. has initiated dosing in a seven day clinical study of a nasal spray formulation of ZT-034 (teriparatide) that is being developed in collaboration with development partner Aegis Therapeutics, LLC. Nasal spray ZT-034 is being developed as an alternative to Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) which generated approximately $800M in annual sales in 2009 for the treatment of osteoporosis and is administered by daily injection.

28 Jan 2010

Haitian President asks for better aid coordination, tents, jobs

Haitian President Rene Preval said the country is in need of sturdy tents and jobs to prevent an ongoing crisis, the Miami Herald reports. At a press conference, Preval said, "Help the people with tents. Create employment so people can buy food in the country. That is what's most important."

28 Jan 2010

NIDA supports Omeros' Addiction program

Omeros Corporation today announced that the National Institute on Drug Abuse (NIDA) is providing support for the Company's Addiction program. NIDA will fund substantially all of the costs of a Phase 2 clinical study to be conducted by New York State Psychiatric Institute researchers.

28 Jan 2010

Life Spine's DYNA-LINK Spinal System and PRESIDIO Spinal Plating System receive FDA marketing clearance

Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to both the DYNA-LINK Spinal System and the PRESIDIO Spinal Plating System.

28 Jan 2010

EnteroMedics to submit an IDE application for next-generation Maestro RC System

EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced today that, following a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s EMPOWER™ study results and the regulatory process, the Company intends to submit an Investigational Device Exemption (IDE) application for a clinical trial to support a possible Premarket Approval (PMA) application for the next-generation Maestro® RC System in the treatment of morbid obesity.

28 Jan 2010

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

28 Jan 2010

NBTY announces record results for fiscal first quarter

NBTY, Inc. (NYSE: NTY), a leading global manufacturer and marketer of nutritional supplements, today announced record results for the fiscal first quarter ended December 31, 2009.

28 Jan 2010

First-quarter fiscal 2010 results announced by Nutraceutical International

Nutraceutical International Corporation today reported results for the fiscal 2010 first quarter ended December 31, 2009. Net sales for the fiscal 2010 first quarter were $44.8 million compared to $39.6 million for the same quarter of fiscal 2009. For the first quarter of fiscal 2010, net income was $3.9 million, or $0.37 diluted earnings per share, compared to net income of $3.1 million, or $0.28 diluted earnings per share, for the same quarter of fiscal 2009.

28 Jan 2010

MPM Capital leads Alnara Pharmaceuticals' $35M Series B venture capital financing

Alnara Pharmaceuticals, Inc., a pharmaceutical company developing non-systemic, orally-delivered protein therapeutics for the treatment of metabolic diseases, announced today that it has secured $35 million in Series B venture capital financing. The round was led by new investor MPM Capital, joined by current investors Third Rock Ventures, Frazier Healthcare and Bessemer Venture Partners. In conjunction with the MPM investment, managing director Ashley Dombkowski, Ph.D., will join Alnara’s board of directors.

28 Jan 2010