Prophylaxis News and Research

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Web site marketing fraudulent H1N1 flu supplements warned by the FDA and the FTC

On October 15, 2009, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

20 Oct 2009

Cangene to acquire U.S. commercialization rights for HepaGam B

Cangene Corporation today announces that it has signed an agreement with its majority shareholder, the Apotex Group, under which Cangene acquires all U.S. commercialization rights for HepaGam B(R) (Hepatitis B Immune Globulin Intravenous (Human)). HepaGam B(R) is Cangene's hepatitis B immune globulin, which is approved for treating two hepatitis-B-related indications in the U.S.

20 Oct 2009

Menarini granted exclusive European licence rights to Ipsen's Adenuric

Ipsen, an innovation-driven global specialty pharmaceutical group, announced an agreement whereby Ipsen grants the Menarini Group the exclusive licence rights to Adenuric® (febuxostat) in 41 countries. Ipsen retains co-promotion rights for Adenuric® in France.

20 Oct 2009

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC- (febuxostat) treatment.

20 Oct 2009

URL Pharma's Colcrys approved by FDA for prevention of gout flares

URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

19 Oct 2009

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Biogen Idec and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients.

19 Oct 2009

Mothers receiving HAART less likely to transmit HIV virus to their newborns through breastfeeding

Mothers receiving highly active antiretroviral therapy (HAART) to treat HIV-1 infection are less likely than untreated mothers to transmit the virus to their newborns through breastfeeding, according to a new study.

19 Oct 2009

FDA urges consumers to exercise care on online H1N1 drug products

The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus.

19 Oct 2009

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL).

15 Oct 2009

Vantia Therapeutics announces the start of Phase II proof-of-concept trials of its VA111913 drug

Vantia Therapeutics today announces that its novel oral small molecule drug for the treatment of dysmenorrhoea (painful menstruation) has entered Phase II proof-of-concept trials. In addition, Vantia announces results of the successful Phase I trial of VA111913, which showed the product candidate to be safe and well tolerated.

6 Oct 2009

Phase 1 clinical trial to test safety and activity of human MAB launched in India

MassBiologics of the University of Massachusetts Medical School today announced the beginning of a Phase 1 clinical trial, testing the safety and activity of a human monoclonal antibody (MAB) developed to neutralize the rabies virus.

1 Oct 2009

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

Prophylaxis News and Research

Web site marketing fraudulent H1N1 flu supplements warned by the FDA and the FTC

Cangene to acquire U.S. commercialization rights for HepaGam B

Menarini granted exclusive European licence rights to Ipsen's Adenuric

Data on ULORIC treatment for gout flares presented at the 73rd American College of Rheumatology meeting

URL Pharma's Colcrys approved by FDA for prevention of gout flares

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Mothers receiving HAART less likely to transmit HIV virus to their newborns through breastfeeding

FDA urges consumers to exercise care on online H1N1 drug products

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Vantia Therapeutics announces the start of Phase II proof-of-concept trials of its VA111913 drug

Phase 1 clinical trial to test safety and activity of human MAB launched in India

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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