Prophylaxis News and Research

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Study highlights challenges of adherence in successful deployment of PrEP interventions

"Data presented from the FEM-PrEP trial by Dr. Lut Van Damme Tuesday at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle highlighted the challenge that adherence plays in successfully deploying effective Pre-Exposure Prophylaxis (PrEP) interventions," HIV Medicine Association Executive Director Andrea Weddle writes in this guest post in the Center for Global Health Policy's "Science Speaks" blog.

8 Mar 2012

Allergan's cell-based assay for botulinum toxin type A products receives positive opinions

Allergan is pleased to announce the company has received two positive opinions regarding its fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX and VISTABEL (Allergan's botulinum toxin type A products).

23 Feb 2012

International Microbicides Conference to take place from April 15-18

The biennial International Microbicides Conference is the premier gathering for those working on new approaches to HIV prevention and this year's conference in Sydney, Australia will place a strong emphasis on the role of community in both research and implementation of scientific findings. The conference will take place from April 15-18 at the Sydney Exhibition and Conference Centre located on the Darling Harbour waterfront.

23 Feb 2012

FDA grants orphan drug designation to CSL Behring's rVIIa-FP

CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin.

16 Feb 2012

AHF dismayed at FDA decision to expedite review for expanded use of Gilead's AIDS drug, Truvada

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration's (FDA) decision to grant an expedited review for Gilead Sciences' application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people.

16 Feb 2012

FDA accepts Gilead's Truvada sNDA and grants Priority Review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.

14 Feb 2012

Positive data from Chimerix CMX001 Phase 2 study on CMV disease

Chimerix, Inc., a biotechnology company developing novel antiviral therapeutics, today announced positive results from CMX001 Study 201, a Phase 2 study evaluating CMX001 for the prevention of cytomegalovirus (CMV) disease in hematopoietic stem cell transplant (HCT) recipients.

6 Feb 2012

Positive results from Chimerix CMX001 study for CMV in hematopoietic stem cell transplant recipients

6 Feb 2012

AHF calls for top to bottom shake-up of management at FDA

AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."

3 Feb 2012

CSL Behring announces results of rIX-FP Phase I study on hemophilia B

CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B.

3 Feb 2012

Study explores links between antiretroviral prophylaxis, cleft lip and palate

HIV-positive mothers have been able to guard against transmitting the disease to their babies by taking antiretroviral drugs during pregnancy. Although the drugs prevent children from being born with HIV, they could cause birth defects, such as cleft lip and palate. A new study explores any links between antiretroviral prophylaxis and cleft lip and palate.

27 Jan 2012

IHS experts develop new guidelines for migraine clinical trials

Experts from the International Headache Society (IHS) have developed new recommendations for conduct of acute and preventive migraine clinical trials. The third edition of Migraine Clinical Trials Guidelines is now available in the IHS journal Cephalalgia, which is published by SAGE.

25 Jan 2012

ViroPharma's NDS for Cinryze receives Health Canada's Priority Review status

ViroPharma Incorporated today announced that Health Canada has granted the company Priority Review status for its New Drug Submission (NDS) for Cinryze (C1 inhibitor [human]).

13 Jan 2012

Study confirms safety and effectiveness of rAHF-PFM in managing hemophilia A

A Rush University Medical Center led international research team has announced that a treatment to prevent bleeding episodes in children with hemophilia A also is effective for adolescents and adults.

10 Jan 2012

CMS assigns permanent J-code for Savient's KRYSTEXXA to treat RCG

Savient Pharmaceuticals, Inc. today announced that a product-specific billing code, or permanent J-code, for KRYSTEXXA (pegloticase) became available on January 1, 2012.

7 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

Veloxis commences LCP-Tacro Phase IIIb study in kidney transplant patients

Veloxis Pharmaceuticals A/S today announced dosing of the first patient in the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) Phase IIIb study of LCP-Tacro in kidney transplant recipients experiencing drug-induced tremors.

4 Jan 2012

New gel could nip Lyme borreliosis infection in the bud

They come out in the spring, and each year they spread further - the ticks. Thirty percent of them transmit borrelia pathogens, the causative agent of Lyme borreliosis that can damage joints and organs.

19 Dec 2011

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

Enrollment complete in ThromboGenics, BioInvent TB-402 Phase IIb trial on VTE

ThromboGenics NV and co-development partner BioInvent International announce today that they have completed the enrolment of a 632-patient Phase IIb trial with their novel long-acting anticoagulant TB-402 for the prophylaxis of venous thromboembolism (VTE) after total hip surgery. The trial has recruited patients from 36 centers across Europe.

17 Dec 2011