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FDA can promote personalized medicine by identying gaps in laboratory operations: ACLA

The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced way according to the American Clinical Laboratory Association (ACLA). ACLA, which represents the nation's leading clinical laboratories, says that the factors supporting this approach include the growing role that such tests play in clinical decision making, especially in the area of new advanced diagnostics that derive from the mapping of the human genome and help fulfill the promise of personalized medicine.

17 Jul 2010

Also in Global Health News: WHO reacts to Amnesty's N. Korea report; Universal flu vaccine; Malaria-resistant mosquitoes

The WHO is questioning the validity of the findings of a recent Amnesty International report which highlighted the dire needs of North Korea's health system, "contradict[ing] the rosier picture given by WHO chief Margaret Chan after her April trip there," the Associated Press reports. Although WHO spokesman Paul Garwood "insisted he wasn't criticizing Amnesty's work … he said Thursday's report was anecdotal, with stories dating back to 2001," which "[h]e contrasted … with WHO's science-based approach" (7/16).

17 Jul 2010

Hemispherx publishes report of Japanese government funded program to develop nasally delivered H5N1 vaccine

Hemispherx Biopharma, Inc. announced that it was publicizing the full technical (unedited) report in Japanese, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease (NIID, formerly Japan's National Institute of Health) and the certified English translation.

16 Jul 2010

New drug launches for HCV in the Philippines to increase market earned revenues to $4.5 billion by 2017

Efforts to raise disease awareness in the Philippines have increased the number of cases and patient pool available for hepatitis C treatment. Screening and detection efforts by the Red Cross as well as growing awareness in the Philippines have been largely responsible for the rise in the number of diagnosed cases. These campaigns have encouraged people, mostly from the urban areas, to opt for physical examinations that enable the detection of hepatitis C.

15 Jul 2010

First 1M doses of smallpox vaccine for immune-compromised populations delivered

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project BioShield contract.

15 Jul 2010

Over half of UK swine flu hospital admissions, deaths occurred in previously healthy people: Research

Over half of UK swine flu hospital admissions and inpatient deaths occurred in people with no underlying health problems or obvious risk factors, research at the University of Liverpool has found.

15 Jul 2010

Hendra virus treatment to be ready in a few months

Of the dozen people who were exposed to a horse infected with the Hendra virus, 11 have been cleared of the infection by repeated tests on Queensland's Sunshine Coast. These 12 people had first come into contact with the infected horse at Tewantin in May and have since then been subjected to testing to rule out infection with the deadly virus. It is expected that the 12th person will also be cleared soon. Quarantine restrictions were also lifted last month.

14 Jul 2010

Health Canada approves FluMist for preventing seasonal influenza

AstraZeneca Canada Inc. announced today that Health Canada has approved FluMist (Influenza Vaccine, Live, Attenuated) for the prevention of seasonal influenza. FluMist is the first vaccine in Canada that is administered as a gentle mist sprayed into the nose.

14 Jul 2010

Call for clarification, education on enactment of new FSA restriction

A provision of health care reform could blindside consumers and create an administrative nightmare for providers and retailers as its January 1, 2011 implementation date draws closer. Without intervention, the Patient Protection and Affordable Health Care Act, passed earlier this year, will require consumers to obtain a physician's "prescription" in order to use their pre-tax flexible spending accounts (FSAs) to pay for over-the-counter (OTC) medicines other than insulin.

14 Jul 2010

Researchers detail innovations that may facilitate earlier detection, improved public health preparedness

With current public health threats ranging from swine flu to bioterrorism to environmental contamination, innovations that better predict disease outbreaks have vast potential to protect the public. In a paper published online in advance of print on July 6 in Emerging Health Threats Journal, public health researchers describe their vision for the future of disease surveillance, detailing innovations on the horizon that may facilitate earlier detection and improved public health preparedness.

14 Jul 2010

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Hi-Tech Pharmacal Co., Inc. today reported results for the fourth quarter and year ended April 30, 2010.

13 Jul 2010

Proper management of asthma during pregnancy reduces risk of harmful effects on babies

Asthma is the most common complication of pregnancy in Australia with harmful effects on babies, but many of these could be prevented a University of Adelaide researcher says.

12 Jul 2010

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

Hemispherx Biopharma, Inc., announced that it has received a report, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease, that summarizes the results of a three year Japanese government funded program to develop and test a nasally delivered H5N1 (Avian Flu) vaccine which, when coupled with Ampligen®, an experimental therapeutic, provided a robust and long lasting immune response to the vaccine.

12 Jul 2010

UM researcher uses computer algorithms to develop vaccines for new strains of influenza viruses

Defeating the flu is challenging because the virus responsible for the disease undergoes frequent changes of its genetic code, making it difficult for scientists to manufacture effective vaccines for the seasonal flu in a timely manner. Now, a University of Miami computer scientist, Dimitris Papamichail, and a team of researchers from Stony Brook University have developed a rapid and effective approach to produce vaccines for new strains of influenza viruses.

9 Jul 2010

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.

9 Jul 2010

WHO report examines donors response to developing countries during H1N1 pandemic

CIDRAP News examines a recently-released WHO report on how donor countries and organizations have responded to the needs of developing countries during the H1N1 (swine flu) pandemic. In September, the WHO estimated the "64 'least-resourced countries' needed a total of $1.48 billion of aid for vaccine, medicines and supplies, laboratory and surveillance services, communications capacity, and other activities to respond to the pandemic," according to the news service.

9 Jul 2010

IBC offers more personalized online information about PHR to its members

Independence Blue Cross now offers its members more personalized online information about their health – as the amazon.com experience is to the savvy shopper, the ibxpress.com experience is to the smart health care consumer. Personal health information began to flow into members' electronic health records this month – available through ibxpress.com, the company's member website.

9 Jul 2010

Study reveals asthma as a risk factor for pneumonia in children hospitalized for influenza

Children with asthma are at increased risk of developing pneumonia as a complication of influenza, reports a study in the July issue of The Pediatric Infectious Disease Journal. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

8 Jul 2010

WHO H1N1 response probe's second meeting highlights divergent views

The independent team of health experts responsible for reviewing the WHO's response to H1N1 (swine flu) wrapped up a second round of public hearings on Friday, "during which members heard testimony from widely divergent groups, from health officials to some of its most public critics," CIDRAP News reports.

7 Jul 2010

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

Hard to Treat Diseases, Inc. and Shenzhen Mellow Hope are excited to announce that the company has secured a new business partner in Ethiopia through which Mellow Hope will distribute biomedical vaccines.

6 Jul 2010

Flu News and Research

FDA can promote personalized medicine by identying gaps in laboratory operations: ACLA

Also in Global Health News: WHO reacts to Amnesty's N. Korea report; Universal flu vaccine; Malaria-resistant mosquitoes

Hemispherx publishes report of Japanese government funded program to develop nasally delivered H5N1 vaccine

New drug launches for HCV in the Philippines to increase market earned revenues to $4.5 billion by 2017

First 1M doses of smallpox vaccine for immune-compromised populations delivered

Over half of UK swine flu hospital admissions, deaths occurred in previously healthy people: Research

Hendra virus treatment to be ready in a few months

Health Canada approves FluMist for preventing seasonal influenza

Call for clarification, education on enactment of new FSA restriction

Researchers detail innovations that may facilitate earlier detection, improved public health preparedness

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Proper management of asthma during pregnancy reduces risk of harmful effects on babies

Report on program to develop, test nasally delivered H5N1 vaccine filed with Japan's MHLW

UM researcher uses computer algorithms to develop vaccines for new strains of influenza viruses

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

WHO report examines donors response to developing countries during H1N1 pandemic

IBC offers more personalized online information about PHR to its members

Study reveals asthma as a risk factor for pneumonia in children hospitalized for influenza

WHO H1N1 response probe's second meeting highlights divergent views

HTDS, Shenzhen Mellow Hope secure new business partner in Ethiopia

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