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Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Emdeon acquires Chamberlin Edmonds

Emdeon Inc., a leading provider of healthcare revenue and payment cycle management solutions, today announced it has completed the acquisition of Chamberlin Edmonds & Associates, Inc., a leading provider of government program eligibility and enrollment services to over 200 acute care facilities in 31 states. Chamberlin Edmonds' technology-enabled services assist hospitals in lowering the incidence of uncompensated care, reducing bad-debt expense and increasing overall cash flow.

4 Oct 2010

FDA approves NovaBone Putty MIS Delivery System for orthopedic surgery

NovaBone Products, a medical device company, today announces the U.S. Food and Drug Administration's (FDA) approval of the NovaBone Putty® MIS Delivery System designed for use in minimally invasive orthopedic procedures.

4 Oct 2010

Meda completes Alaven acquisition

Meda has completed the acquisition of Alaven and has taken over its operations. The acquisition will benefit Meda both short term and long term. The acquisition will add the therapeutic focus to include both gastroenterology and women's health; areas that Meda operates in outside of the US. In addition, Alaven has a strategic OTC platform that accounts for approximately 25% of sales. Alaven will further diversify Meda's revenue base in the US, as well as serve as a platform for commercializing strategic pipeline opportunities.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Excessive profits made by cigarette manufacturers need to be capped

An independent regulatory agency is needed to cap the excessive profits made by cigarette manufacturers, say researchers from the University of Bath.

4 Oct 2010

NextGen Ambulatory EHR version 5.6 SP1 achieves ONC-ATCB 2011/2012 certification

NextGen Healthcare Information Systems, Inc., a wholly owned subsidiary of Quality Systems, Inc. and a leading provider of healthcare information systems and connectivity solutions, announced today that NextGen® Ambulatory EHR version 5.6 SP1 is 2011/2012 compliant and was certified as a Complete EHR on September 30, 2010 by the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, in accordance with the applicable eligible provider certification criteria adopted by the Secretary of Health and Human Services.

4 Oct 2010

Integra LifeSciences launches EGR system in the U.S.

Integra LifeSciences Holdings Corporation announced today the launch of the Integra™ Endoscopic Gastroc Release (EGR) System in the United States. Integra's EGR System is a disposable device with a unique articulating blade that allows selective cutting of soft tissues. It is intended for use in the surgical treatment for posterior heel cord, or equinus, contracture.

4 Oct 2010

Non-reversible gastric bypass surgery linked to increased risk of fetal neural tube defects

An increasing number of obese adolescents, particularly females, are undergoing gastric bypass surgery. Yet a case study presented Sunday, Oct. 3, at the American Academy of Pediatrics (AAP) National Conference and Exhibition in San Francisco, highlights the possible link between gastric bypass surgery in adolescent girls and an increased risk for neural tube defects, which can lead to varying degrees of disability such as paralysis and mental retardation due to damage to the nervous system, in their future children.

4 Oct 2010

Most toddlers able to reach kitchen countertops

Most toddlers can reach as high as a kitchen countertop, putting them at risk for severe burns from hot liquids, according to research presented Sunday, Oct. 3, 2010, at the American Academy of Pediatrics (AAP) National Conference and Exhibition in San Francisco.

4 Oct 2010

Increase in unemployment rate linked to child maltreatment

The stresses of poverty have long been associated with child abuse and neglect. In a study presented Sunday, Oct. 3, at the American Academy of Pediatrics (AAP) National Conference and Exhibition in San Francisco, researchers directly linked an increased unemployment rate to child maltreatment one year later.

4 Oct 2010

Pharmatek adds roller compaction to GMP manufacturing facilities

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has added roller compaction to its solid oral dosage form manufacturing capabilities. The company has purchased two roller compactors, a pilot-scale Vector TFC-220 roller compactor with a rate of 20 kg/hour, and a Vector TFC-LAB Micro lab-scale roller compactor with a rate of 1 kg/hour. Both machines have been integrated into Pharmatek's GMP facility and are ready for GMP manufacturing.

4 Oct 2010

MedCath sells two hospitals

MedCath Corporation announced today the completion of sales involving its interests in two hospitals, Arizona Heart Hospital and Avera Heart Hospital of South Dakota.

4 Oct 2010

Mylan subsidiary receives FDA approval for Fludarabine Phosphate Injection ANDA

Mylan Inc. today announced that its subsidiary Bioniche Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).

4 Oct 2010

Viking Systems increases cash and liquidity through common stock issue

Viking Systems, Inc. said today that it has increased its cash and liquidity position through the issuance of common stock. In a series of transactions from August 4, 2010 through September 30, 2010, the Company raised $1,171,117 by selling an aggregate of 3,665,335 shares of its common stock through its previously announced financing facility with Dutchess Opportunity Fund, II, LP.

4 Oct 2010

First Edition: October 4, 2010

In this Kaiser Health News column, Louis Saccoccio, executive director of the National Health Care Anti-Fraud Association, makes a case for including health plans' investments in fraud-fighting activities in the medical loss ratio definition. "While the federal government is investing heavily in anti-fraud efforts, private insurers should be given the incentive to do the same. Only through a cooperative and concentrated effort to root out health care fraud can we effectively protect Americans' quality of health care" (Kaiser Health News).

4 Oct 2010

Puerto Rican's awarness of genetic testing high, but usage low

Awareness of genetic testing was higher among adults in Puerto Rico compared to previous U.S. population-based studies, while use of genetic testing was lower, according to data presented at the Third AACR Conference on the Science of Cancer Health Disparities, held Sept. 30 to Oct 3, 2010.

4 Oct 2010

Nicotine reduction strategy should be an urgent research priority

After a major review of scientific information, six leading tobacco research and policy experts have concluded that a nicotine reduction strategy should be an urgent research priority because of its potential to profoundly reduce the death and disease from tobacco use. Their findings were published today in the journal Tobacco Control.

4 Oct 2010

Alexander Technique training program improves endurance and posture during surgery

A century-old posture improvement technique developed by Shakespearian actor F.M. Alexander to correct his chronic laryngitis appears to enhance the posture and proficiency of surgeons who perform minimally invasive procedures.

4 Oct 2010