Prophylaxis News and Research

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Amgen and Centocor Ortho Biotech Products: FDA approves REMS for Aranesp, EPOGEN and PROCRIT ESAs

Amgen Inc. and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa).

17 Feb 2010

Quark Pharmaceuticals' QPI-1002 receives orphan drug designation from FDA

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today that the US FDA has granted orphan drug designation for QPI-1002 (also referred to as "I5NP"), a synthetic siRNA targeting p53 mRNA for the prophylaxis of delayed graft function (DGF) in kidney transplant patients.

17 Feb 2010

People living with IBD are at high risk of blood clots

People living with Inflammatory Bowel Disease (IBD) are known to be at high risk of blood clots when admitted to hospital during a flare-up of their disease but now new research by scientists at The University of Nottingham has shown that those who are not admitted to hospital during flare-ups are also at risk.

10 Feb 2010

2010 HSR Impact Award recognizes research that improves patient safety and surgical outcomes

AcademyHealth today recognized research that improves patient safety and surgical outcomes with the 2010 Health Services Research (HSR) Impact Award. The WHO Surgical Safety Checklist was created as a tool to ensure adherence to basic safety standards of care.

9 Feb 2010

USPTO awards NexBio patent covering sialidase pharmaceutical compositions and methods of treating influenza

NexBio, Inc. today announced the issuance by the United States Patent and Trademark Office of United States Patent No. 7,645,448 entitled "Class of Therapeutic Protein Based Molecules". This patent covers NexBio's sialidase pharmaceutical compositions, including its lead compound DAS181 (Fludase®), and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions.

9 Feb 2010

Providing Tamiflu and educating on sanitizer use helped to stop spread of H1N1 at boys' summer camp

Providing preventive Tamiflu and educating and emphasizing the need for repeated hand sanitizer use and disinfectant spray helped stop the spread of H1N1 influenza at a boys' summer camp in northern Alabama, according the co-director of the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases.

4 Feb 2010

Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

Prometheus Laboratories executes commercialization agreement with Novartis

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced the execution of a commercialization agreement with Novartis under which Prometheus acquired exclusive rights to distribute, promote and sell PROLEUKIN® (aldesleukin) in the United States.

27 Jan 2010

Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

25 Jan 2010

Getting vaccinated within five days after exposing to chickenpox prevents chickenpox

For people who haven't had chickenpox and are exposed to an ill family member, getting vaccinated within five days can reduce the risk of developing chickenpox—or at least reduce the severity of disease, reports a study in the January issue of The Pediatric Infectious Disease Journal.

21 Jan 2010

Study: PrEP treatment offers protection against HIV transmission in humanized mice

Systemic pre-exposure administration of antiretroviral drugs provides protection against intravenous and rectal transmission of HIV in mice with human immune systems, according to a new study published January 21, 2010 in the online journal PLoS ONE.

21 Jan 2010

Three hospitals selected as recipients of the 2009 DVTeamCare Hospital Award

The North American Thrombosis Forum (NATF), in coordination with Eisai Inc., announced today that three hospitals have been selected as recipients of the 2009 DVTeamCare Hospital Award. This new award was established by Eisai to recognize hospitals that have made a significant commitment to preventing deep vein thrombosis (DVT) and its potentially fatal complications, including pulmonary embolism (PE).

20 Jan 2010

Antibiotics can reduce infections post-Caesarean section

Having a baby by Caesarean section is becoming increasingly common, despite the higher risks associated with the surgery compared to a vaginal birth. One important concern is the risk of infection, which is between five and 20 times greater for women who undergo scheduled or emergency Caesarean section.

20 Jan 2010

ViroPharma signs agreement with Sanquin Blood Supply Foundation to develop and commercialize Cinryze

ViroPharma Incorporated today announced that it has signed an agreement with Sanquin Blood Supply Foundation for rights to develop, file regulatory dossiers, and commercialize Cinryze(TM) (C1 esterase inhibitor [human]) for hereditary angioedema (HAE) as well as for potential new indications in certain European and rest of world (ROW) territories.

12 Jan 2010

RMEI and PIM sponsor medical education virtual lecture for physicians on HAE management

Hereditary angioedema (HAE) is a disease affecting between 4,000 and 10,000 people in the United States each year, causing recurrent attacks of intense localized edema. HAE can be both difficult to diagnose and difficult to treat.

7 Jan 2010

DSMB recommends Quark Pharmaceuticals to continue clinical study of QPI-1002

Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today that the independent Data Safety Monitoring Board ("DSMB") recommended that QPI-1002 (I5NP) continue on to the next phase of clinical testing.

5 Jan 2010

D-Pharm commences enrollment in MACSI Phase III clinical study for acute ischemic stroke

D-Pharm Ltd announced enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI). The first patient has been enrolled at the Wolfson Medical Center, Israel. The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm's most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).

3 Jan 2010

Colcrys Patient Assistance Program introduced by URL Pharma

URL Pharma, Inc. announced the launch of the Colcrys® (colchicine, USP) Patient Assistance Program, an initiative that will allow patients with limited means to save on Colcrys prescriptions. This program reflects URL Pharma's ongoing commitment to helping ensure that all patients who rely on the company's medications are able to access them, regardless of economic status. Colcrys is indicated for the prevention and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF).

24 Dec 2009

U.S. health officials announce shift in focus of prep trial in Botswana

U.S. health officials on Thursday announced they will shift the focus of a clinical trial in Botswana aimed at testing pre-exposure prophylaxis (PrEP) - the strategy that "a daily low dose of the drugs, which interfere with the ability of the virus to replicate, could also lower the risk of infection" - after researchers discovered they would be unable to determine the efficacy of Truvada, the medicine used in the trial, Reuters reports.

18 Dec 2009

Rib-X Pharmaceuticals and MGH enter into collaborative research agreement

Rib-X Pharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel drugs for the treatment of serious multi-drug-resistant infections announced today it has entered into a collaborative research agreement with Massachusetts General Hospital (MGH).

16 Dec 2009