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Mass poultry vaccination programmes lead to dramatic decline in Salmonella infections

Mass poultry vaccination programmes introduced to combat Salmonella infections have led to a dramatic fall in the number of cases since the late 1990s, according to a researcher at the University of Liverpool.

17 Jan 2013

FDA clears Zimmer’s iASSIST technology for knee replacement procedures

Zimmer Holdings, Inc., a global leader in musculoskeletal health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market iASSIST Knee, the Personalized Guidance System for knee replacement procedures.

17 Jan 2013

Viewpoints: Obama 'wise' to add mental health focus to gun initiative; Calif. considers giving localities responsibility for expanded Medicaid

President Obama's sweeping proposals to combat gun violence represent a sound response to the mass shootings that have horrified the country. In his legislative proposals and executive actions announced Wednesday, the president and Vice President Biden showed a willingness to confront a difficult problem head-on -- a problem that is not only about laws but also about culture and mental-health care.

17 Jan 2013

SyNAPSe® Trial by BHR Pharma deemed to have no safety issues according to DSMB

BHR Pharma, LLC announced today that the SyNAPSe® Trial's independent Data and Safety Monitoring Board (DSMB) evaluated safety data from 803 randomized patients and determined that no issues exist; therefore, the trial may continue towards its intended completion.

17 Jan 2013

Head-scratching persists despite nodding syndrome study

Nodding syndrome is an epileptic disorder, with telltale nodding episodes caused by atonic seizures, concludes a pioneering study of the mysterious neurologic illness that has been reported in only three African countries.

17 Jan 2013

FDA clears Sanovas’ Vas Zeppelin Smart Catheter to treat chronic pulmonary diseases, lung cancer

Sanovas Inc., a life science technology company developing and commercializing the next-generation of micro-invasive diagnostics, devices and drug delivery technologies, announced today that it has filed with the U.S. Food and Drug Administration for clearance of the company's Vas Zeppelin Smart Catheter for the treatment of chronic pulmonary diseases and lung cancer.

17 Jan 2013

Carob extract could fight the microbe responsible for listeriosis

The latest episode in the American Chemical Society's (ACS') award-winning Global Challenges/Chemistry Solutions podcast series reports that an antibacterial extract from the leaves of the carob tree (the source of a popular chocolate substitute) could fight the microbe responsible for the serious form of food poisoning called listeriosis.

17 Jan 2013

IRIN examines global food situation for 2013

"IRIN -- with the help of food experts, the most recent reports from [the U.N. Food and Agriculture Organization (FAO)] and the U.S. Department of Agriculture (USDA) -- reflects on the global food situation in 2012 and the outlook for 2013," the news service reports

17 Jan 2013

New menu of 61 genetically engineered E. coli strains may improve efficacy of vaccines

Researchers at The University of Texas at Austin have developed a menu of 61 new strains of genetically engineered bacteria that may improve the efficacy of vaccines for diseases such as flu, pertussis, cholera and HPV.

17 Jan 2013

Many people still affected with asthma after exposure to chemicals at work

Despite known risks and recommendations for protective equipment, many people are still affected with asthma after exposure to chemicals at work. This is the finding of an international study of 13,000 people carried out at the Sahlgrenska Academy, University of Gothenburg, Sweden.

17 Jan 2013

QrxPharma to resubmit MOXDUO NDA with FDA

QRxPharma Limited announced today that the steps necessary for approval of immediate release MOXDUO have been clarified with the United States Food and Drug Administration (FDA).

17 Jan 2013

Cuban authorities work to contain cholera outbreak in capital city

"Cuban authorities are scrambling to contain a cholera outbreak that has sickened dozens of people in Havana, the capital city of 2.2 million residents and a popular tourism destination," Reuters reports.

17 Jan 2013

Partisan strife, interest group concerns emerge in spending debate

The New York Times explores how intra-GOP allegiances to the business community are changing. Meanwhile, AARP acknowleges that adjustments must be made, but argues against cutting back entitlements. Also in the news, the director of the National Institutes of Health expresses his wariness about the impact sequestration could have on biomedical research.

17 Jan 2013

FDA categorizes Cepheid's Xpert CT/NG test as 'Moderate Complexity' under CLIA

Cepheid today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert CT/NG test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA).

17 Jan 2013

Boston Scientific initiates Blazer Open-Irrigated Catheter clinical trial in atrial fibrillation

The first patient has been treated in the Boston Scientific Corporation ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation.

17 Jan 2013

FDA approves St. Jude Medical’s Merlin.net Patient Care Network

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the next-generation Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

17 Jan 2013

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).

17 Jan 2013

FDA approves InfraScan’s noninvasive handheld brain hematoma detector

InfraScan, a medical device company specializing in brain injury diagnostic products, announced today that it has obtained U.S. Food and Drug Administration approval to market the Infrascanner Model 2000, a noninvasive handheld brain hematoma detector.

17 Jan 2013

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations.

17 Jan 2013

Protein Sciences receives FDA approval for Flublok vaccine

The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

16 Jan 2013