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FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). [More]
Research provides definitive evidence of safety of Tdap immunization during pregnancy

Research provides definitive evidence of safety of Tdap immunization during pregnancy

A preliminary study finds that receipt of the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in the third trimester of pregnancy did not increase the risk of adverse events for the mother or infant, according to a study in the May 7 issue of JAMA, a theme issue on child health. [More]
Sinovac Biotech commits to commercialize Sabin Inactivated Polio Vaccine in China

Sinovac Biotech commits to commercialize Sabin Inactivated Polio Vaccine in China

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China that focuses on the research, development, manufacturing and commercialization of vaccines, announced today that it has entered into a license agreement with Intravacc (Institute for Translational Vaccinology) from The Netherlands to develop and commercialize the Sabin Inactivated Polio Vaccine (sIPV) for distribution to China and other countries. [More]
Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Alexion Pharmaceuticals obtains orphan drug designation from EC for Soliris

Alexion Pharmaceuticals, Inc. today announced that the European Commission has granted an orphan drug designation (ODD) to Soliris (eculizumab), a first-in-class terminal complement inhibitor, for the prevention of graft rejection following solid organ transplantation. Graft rejection can cause severe injury to the transplanted organ and is a significant barrier to successful transplantation. [More]
Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer Inc. announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. [More]
Doctors must consider factors when administering combination vaccines, say researchers

Doctors must consider factors when administering combination vaccines, say researchers

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive option, according to a new study by University of Illinois researchers. [More]

Quest Diagnostics acquires Summit Health

Quest Diagnostics, the world's leading provider of diagnostic information services, has completed the previously announced acquisition of Summit Health, a leading provider of on-site prevention and wellness services. Financial terms were not disclosed. [More]
FDA grants Orphan Drug Designation to Emergent BioSolutions' BioThrax for PEP of anthrax disease

FDA grants Orphan Drug Designation to Emergent BioSolutions' BioThrax for PEP of anthrax disease

Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. [More]
Evidence-based interventions provide promising strategies for reducing racial, ethnic health disparities

Evidence-based interventions provide promising strategies for reducing racial, ethnic health disparities

Evidence-based interventions at the local and national levels provide promising strategies for reducing racial and ethnic health disparities related to HIV infection rates, immunization coverage, motor vehicle injuries and deaths, and smoking, according to a new report by the CDC's Office of Minority Health and Health Equity. [More]
Pitt CVR and Sanofi Pasteur join forces to help assess effectiveness of dengue vaccine

Pitt CVR and Sanofi Pasteur join forces to help assess effectiveness of dengue vaccine

The University of Pittsburgh Center for Vaccine Research (CVR) and Sanofi Pasteur, the vaccines division of Sanofi, have entered a scientific collaboration to help assess the effectiveness of a dengue vaccine once introduced for immunization programs. [More]
Study: Immunization program in UK has reduced HPV infections in young women

Study: Immunization program in UK has reduced HPV infections in young women

Each year around 2,000-2,500 women are diagnosed with cervical cancer in England, the most common cancer in women under 35. Infection with high-risk human papillomavirus (HR HPV) types 16 and 18 is responsible for around 70-80% of cervical cancers. [More]
Criterions EHR certified under Drummond Group's ONC-ACB program

Criterions EHR certified under Drummond Group's ONC-ACB program

Criterions EHR version 3.0 has been tested and certified under the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body program. This EHR software is compliant in accordance with the criteria adopted by the Secretary of the U.S. Department of Health and Human Services. [More]
NextGen earns ONC 2014 Edition criteria certification for Emergency Department Solution

NextGen earns ONC 2014 Edition criteria certification for Emergency Department Solution

NextGen Healthcare Information Systems, LLC., a wholly owned subsidiary of Quality Systems, Inc. (NASDAQ: QSII) and a leading provider of healthcare information systems and connectivity solutions, announced today that NextGen® Emergency Department Solution version 6.0 is compliant with the ONC 2014 Edition criteria and was certified as an electronic health record (EHR) Module on March 7, 2014 by the Certification Commission for Health Information Technology (CCHIT®), an ONC-ACB, in accordance with the applicable Hospital certification criteria adopted by the Secretary of Health and Human Services. [More]
New research reveals that immunization can trigger distinct change in body odor

New research reveals that immunization can trigger distinct change in body odor

​Our understanding of the role of body odor in conveying personal information continues to grow. New research from the Monell Chemical Senses Center and the U.S. Department of Agriculture (USDA) reveals that immunization can trigger a distinct change in body odor. This is the first demonstration of a bodily odor change due to immune activation. [More]
FDA expands age indication of Adacel vaccine for immunization against tetanus, diphtheria, pertussis

FDA expands age indication of Adacel vaccine for immunization against tetanus, diphtheria, pertussis

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has expanded the approved age indication of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; Tdap) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 10 through 64 years of age. [More]
CDC receives 2014 Franz Edelman Award for Achievement in Operations Research and Management Sciences

CDC receives 2014 Franz Edelman Award for Achievement in Operations Research and Management Sciences

​The U.S. Centers for Disease Control and Prevention (CDC), which collaborated with Kid Risk, Inc. to use analytics and operations research to combat the remaining pockets of polio around the world, last night won the 2014 Franz Edelman Award for Achievement in Operations Research and the Management Sciences at a banquet sponsored by the Institute for Operations Research and the Management Sciences (INFORMS) in Boston. [More]
CDC receives 2014 Franz Edelman Award for Achievement in Operations Research, Management Sciences

CDC receives 2014 Franz Edelman Award for Achievement in Operations Research, Management Sciences

The U.S. Centers for Disease Control and Prevention (CDC), which collaborated with Kid Risk, Inc. to use analytics and operations research to combat the remaining pockets of polio around the world, tonight won the 2014 Franz Edelman Award for Achievement in Operations Research and the Management Sciences at a banquet sponsored by the Institute for Operations Research and the Management Sciences (INFORMS) in Boston. [More]
Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

Two doses of HPV-16/18 AS04-adjuvanted vaccine Cervarix non-inferior to three-doses

A recent study in the journal Human Vaccines & Immunotherapeutics, showed that two doses of the HPV-16/18 AS04-adjuvanted vaccine Cervarix (GlaxoSmithKline) are non-inferior to three-doses in the current schedule. [More]
Roundup: Calif. malpractice cap ballot measure; Colo. immunizations bill; Fla. cash-only clinic loophole

Roundup: Calif. malpractice cap ballot measure; Colo. immunizations bill; Fla. cash-only clinic loophole

A selection of health policy stories from California, Colorado, Florida, Arizona, Virginia, Maryland and Massachusetts. [More]
Viewpoints: Mcconnell, Wasserman Schultz, Barasso on Obamacare's 4th anniversary; defending surgeon general nominee

Viewpoints: Mcconnell, Wasserman Schultz, Barasso on Obamacare's 4th anniversary; defending surgeon general nominee

The promises that were made to sell Obamacare -; that it wouldn't disrupt people's previous health care arrangements and that premiums would go down -; are now being exposed for the cheap and deceptive sales pitch they were. It may be tempting for some to brush all this aside as standard politics. [More]