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Zevalin radioimmunotherapy drug approved for treating non-Hodgkin's lymphoma

SNM applauds the U.S. Food and Drug Administration's (FDA) recent decision to approve the radioimmunotherapy (RIT) drug, Zevalin, as a front-line treatment of non-Hodgkin's lymphoma (NHL).

11 Sep 2009

Abbreviated New Drug Application for nateglinide tablets approved

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets.

11 Sep 2009

New Drug Application for trabectedin approved by the FDA

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer.

11 Sep 2009

Students do not comply with basic preventative measures to combat H1N1

As public health experts warn of potential widespread outbreaks of H1N1 flu this school year, a new study from North Carolina State University shows that students do not comply with basic preventative measures as much as they think do. In other words, the kids aren't washing their hands.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Today's editorials and opinions

At Last, Firing Back On Health Reform The Washington Post [T]he most striking aspect of the address may have been its call to battle: The days of taking incoming fire without any return volleys are over (E.J. Dionne, Jr., 9/10).

10 Sep 2009

Also in Global Health news: PEPFAR in Swaziland; GSK HIV patent pool; Pediatric ARVs in Uganda; PNG declares health emergency; Israeli, ECOWAS agreement; Somali children

PEPFAR on Wednesday donated eight computers to Swaziland's Ministry of Health to aid in the country's ability to track the progress of the nation's HIV/AIDS programs, the Swazi Observer reports. According to the newspaper, the computers will be distributed to regional clinics across the country (Masilela, 9/10).

10 Sep 2009

Drought, food shortages lead Guatemala to declare 'state of public calamity'

"Guatemalan President Alvaro Colom declared 'a state of public calamity' late Tuesday to help mobilize funds and resources to confront a food shortage that will affect thousands of families," the Associated Press reports (9/9).

10 Sep 2009

FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

10 Sep 2009

Quatrx' second phase 3 study of ospemifene tablets provides positive results

QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, today announced positive efficacy results from the second of two patient cohorts in the second pivotal Phase 3 study for Ophena(TM) (ospemifene tablets), the company's investigational compound in development for the treatment of postmenopausal vulvovaginal atrophy (VVA).

10 Sep 2009

Health care reform should tackle food safety

Linda Rivera’s excruciating case of food poisoning (Severe Case Gives Context to Issue of Food Safety Washington Post 9/1/09) should shine some light on a crucial reality that is missing from most health care reform plans: you can’t fix America’s health care unless you provide Americans with a safe food supply.

10 Sep 2009

FDA removes clinical hold on HEPLISAV hepatitis B vaccine

Dynavax Technologies Corporation today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease.

10 Sep 2009

METOZOLV drug approved for treating gastroesophageal reflux disease

Wilmington Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) has granted marketing approval for METOZOLV ODT (metoclopramide HCl), an orally disintegrating formulation of metoclopramide for the treatment of gastroesophageal reflux disease (GERD) and diabetic gastroparesis.

10 Sep 2009

Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Inspire Pharmaceuticals, Inc. announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

10 Sep 2009

Family mealtimes promote healthy eating habits

In a new report, University of Illinois professor Barbara H. Fiese urges local, state, and federal governments, businesses, and community leaders to promote family mealtimes as a matter of public policy.

10 Sep 2009

Natural plant hormone can help eliminate pesticide residues in food crops

Scientists in China are reporting the "intriguing" discovery that a natural plant hormone, applied to crops, can help plants eliminate residues of certain pesticides. The study is scheduled for the Sept. 23 issue of ACS' Journal of Agricultural and Food Chemistry, a bi-weekly publication.

10 Sep 2009

Varying physical activity for optimal health benefits

How hard and for how long should you exercise in order to shed excess abdominal fat and reduce your risk of cardiovascular disease?

10 Sep 2009

New Influenza A/H1N1 detection kit launched

QIAGEN, today announced both the launch of a new Influenza A/H1N1 test and several updates to its activities in providing solutions for the global surveillance of the swine flu pandemic. QIAGEN’s new kit enables both the highly sensitive and specific detection of the novel Influenza A/H1N1, the virus that causes “swine flu”, as well as of all other known Influenza A and B virus strains.

10 Sep 2009

GlaxoSmithKline's CERVARIX receives favorable recommendation from FDA Advisory Committee

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX((R)), the company's candidate cervical cancer vaccine (12-1 and 11-1, respectively).

10 Sep 2009

Newly formed Med-Vet-Net Association to be launched

To celebrate and reflect on the scientific achievements of one of Europe's most successful Networks of Excellence, and to launch the newly formed Med-Vet-Net Association — the future incarnation of the Med-Vet-Net partnership that will forge ahead with research tackling the zoonoses and food-borne diseases that threaten the public health of the European Community.

10 Sep 2009