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Covidien receives 510(k) clearance to market Mallinckrodt Taperguard Evac endotracheal tube

Covidien, a leading global provider of healthcare products and recognized innovator in mechanical ventilation and respiratory care devices, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Mallinckrodt™ TaperGuard™ Evac endotracheal tube.

1 Oct 2009

It is possible to reduce the risk of HIV infection with a vaccine: AVAC

"Today marks an historic milestone in the search for an AIDS vaccine; we now have evidence that it is possible to reduce the risk of HIV infection with a vaccine," said AVAC executive director Mitchell Warren, reacting to the results of the first AIDS vaccine trial to ever show efficacy at preventing HIV. "It will take time and resources to fully analyze, understand and validate the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit."

24 Sep 2009

CSL Behring offers new dosage strength of Helixate FS in U.S.

Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.

22 Sep 2009

U.S. Department of Health & Human Services requests BioCryst for proposal for peramivir supply

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has received a request for proposal (RFP) from the U.S. Department of Health & Human Services (HHS) for the supply of intravenous (i.v) peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization (EUA).

21 Sep 2009

Single inoculation for rabies vaccination

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21 Sep 2009

Intermittent preventive treatment could prevent a third of infant malaria cases, study finds

Research into intermittent preventive treatment of malaria in infants (IPTi) found that one-third of malaria cases in African babies can be prevented by giving them regular doses of malaria drugs even if they have not contracted the disease, according to a Lancet study, published on Thursday, Reuters reports. The study found that IPTi "helped children build better immunity to the disease and reduced the risk of the parasite becoming drug-resistant," but "these benefits decrease if treatment is given continuously as a prophylaxis," Reuters writes.

18 Sep 2009

Preventive treatment extension after kidney transplantation reduces the risk of CMV disease

For kidney transplant recipients, infection with a virus called cytomegalovirus (CMV) may lead to devastating complications. New research suggests that extending the period of preventive treatment after kidney transplantation can reduce the risk of CMV disease, according to an upcoming report in the Journal of the American Society of Nephrology (JASN).

18 Sep 2009

Second-quarter fiscal 2009 results announced by Gentium

Gentium S.p.A. (NASDAQ: GENT) today reported financial results for the second quarter ended June 30, 2009.

17 Sep 2009

Study: Antiretroviral drugs may prevent HIV infection in women

Hopeful that some of the same antiretroviral (ARV) drugs used to treat HIV infection can also prevent it, researchers from the Microbicide Trials Network have enrolled the first participants into a new, large-scale clinical trial testing two approaches of the strategy in women.

17 Sep 2009

VOICE clinical study for testing the efficacy of two HIV prevention strategies

A new, large-scale clinical trial is examining whether antiretroviral medications normally used to treat HIV infection can also prevent HIV infection in women when applied as a vaginal gel or taken as oral tablets once daily.

16 Sep 2009

Rib-X and NIAID collaborate to develop an antibiotic treatment for N. gonorrhoeae

Rib-X Pharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel drugs for the treatment of multi-antibiotic resistant infections, today announced that it intends to enter into a Clinical Trials Agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services.

15 Sep 2009

AzaSite production increased to combat erythromycin ophthalmic ointment shortage

InSite Vision Incorporated today announced that Inspire Pharmaceuticals, its commercial partner for AzaSite (azithromycin ophthalmic solution) 1% in the U.S and Canada, has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

15 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

Published today, as an original investigation, in the peer-reviewed Journal of Clinical Oncology, are statistically significant Phase II clinical results of The GI Company's lead clinical compound, rhITF (recombinant human Intestinal Trefoil Factor) oral spray. The article is titled, "A Phase II, Randomized, Double-blind, Placebo-Controlled Study of rhITF Oral Spray for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving 5-Fluorouracil-based Chemotherapy."

10 Sep 2009

St. Vincent develops the first-ever HIV educational widget

Saint Vincent Catholic Medical Centers and the New York State Department of Health (DOH) today unveiled a novel Web-based technology to rapidly instruct health care providers throughout New York State about HIV diagnosis and prevention.

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

Phase III trials for CS-8958 neuraminidase inhibitor successful

Hovione is pleased to announce that its TwinCaps(R) inhaler licensees Daiichi Sankyo Co. Ltd. (Tokyo, Japan) and Biota Holdings Ltd (Victoria, Australia) have both announced successful Phase III trials for CS-8958, a new long-acting neuraminidase inhibitor for treatment of influenza (known as a prodrug of laninamivir).

9 Sep 2009

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that data from the Company's third generation recombinant protective antigen (rPA) anthrax vaccine program and its Valortim((R)) anthrax anti-toxin program were presented at the Bacillus - ACT 2009 meeting, August 30 - September 3, 2009, organized by the American Society for Microbiology.

4 Sep 2009

Sheller, P.C helps to settle the largest whistleblower complaint

Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise. The drug giant also defrauded federal and state taxpayers by marketing Zyvox off-label, according to a qui tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and other documents unsealed with today's $2.3 billion Pfizer settlement.

3 Sep 2009

Pathogenic microbes can suppress immune system in newborns

Group B Streptococcus (GBS), a bacterial pathogen that causes sepsis and meningitis in newborn infants, is able to shut down immune cell function in order to promote its own survival, according to researchers at the University of California, San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences.

2 Sep 2009

Prophylaxis News and Research

Covidien receives 510(k) clearance to market Mallinckrodt Taperguard Evac endotracheal tube

It is possible to reduce the risk of HIV infection with a vaccine: AVAC

CSL Behring offers new dosage strength of Helixate FS in U.S.

U.S. Department of Health & Human Services requests BioCryst for proposal for peramivir supply

Single inoculation for rabies vaccination

Intermittent preventive treatment could prevent a third of infant malaria cases, study finds

Preventive treatment extension after kidney transplantation reduces the risk of CMV disease

Second-quarter fiscal 2009 results announced by Gentium

Study: Antiretroviral drugs may prevent HIV infection in women

VOICE clinical study for testing the efficacy of two HIV prevention strategies

Rib-X and NIAID collaborate to develop an antibiotic treatment for N. gonorrhoeae

AzaSite production increased to combat erythromycin ophthalmic ointment shortage

Merck update on the status of telcagepant clinical development programs

GI Company's Phase II study demonstrates safety of rhITF oral spray formulation

St. Vincent develops the first-ever HIV educational widget

Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Phase III trials for CS-8958 neuraminidase inhibitor successful

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

Sheller, P.C helps to settle the largest whistleblower complaint

Pathogenic microbes can suppress immune system in newborns

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