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Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults. [More]
Bioethics Commission makes recommendations on preparedness for public health emergencies

Bioethics Commission makes recommendations on preparedness for public health emergencies

Today the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) reported that the federal government has both a prudential and a moral responsibility to actively participate in coordinated global responses to public health emergencies wherever they arise. [More]
Study shows how financial incentives can influence some HIV-positive patients in clinical settings

Study shows how financial incentives can influence some HIV-positive patients in clinical settings

A new study by the HIV Prevention Trials Network shows that some HIV-positive patients were motivated by financial incentives to take their HIV antiretroviral therapy (ART) medication regularly and maintain control of their HIV - enhancing their own health benefits and reducing the chance of passing the virus on to others. [More]
Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-PKKRx. In this study, healthy volunteers treated with ISIS-PKKRx achieved dose-dependent reductions of up to 95 percent in prekallikrein, or PKK. ISIS-PKKRx is a RNA-targeted antisense drug designed to inhibit the production of PKK for the prophylactic treatment of hereditary angioedema (HAE). [More]

Added benefit of simoctocog alfa not proven for haemophilia A

Simoctocog alfa (trade name Nuwiq) has been approved since July 2014 for people with type A haemophilia, an inherited disorder that impairs blood clotting. The German Institute for Quality and Efficiency in Health Care examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier, however, because the drug manufacturer did not submit any suitable data. [More]
HIV Prevention Trials Network launches two phase 2 studies to evaluate new HIV drugs

HIV Prevention Trials Network launches two phase 2 studies to evaluate new HIV drugs

The HIV Prevention Trials Network has launched two new phase 2 studies, HPTN 076 and HPTN 077, which are designed to evaluate new drugs to protect people from getting infected with HIV. [More]
NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

Two new clinical trials are examining the safety and acceptability of antiretroviral medicines administered via injection as a means of protecting against HIV infection. The studies are being funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and conducted by the NIAID-funded HIV Prevention Trials Network (HPTN). [More]
Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis. [More]
New AGA guideline provides guidance to prevent HBV reactivation

New AGA guideline provides guidance to prevent HBV reactivation

Long-term immunosuppressive therapy can cause the hepatitis B virus (HBV) to become active, even in patients who are not aware that they are infected with the virus. A new guideline from the American Gastroenterological Association provides guidance to physicians and patients who use immunosuppressive agents for the treatment of a variety of disorders, including gastrointestinal, dermatologic, neurologic and rheumatologic, among others. [More]
National #KnowBetterDoBetter movement comes to Los Angeles to end AIDS epidemic

National #KnowBetterDoBetter movement comes to Los Angeles to end AIDS epidemic

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to Los Angeles, CA and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with greater knowledge and skills. [More]

National #KnowBetterDoBetter movement comes to Houston to end AIDS epidemic

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to Houston and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with greater knowledge and skills. [More]

National #KnowBetterDoBetter movement comes to Chicagoland to end AIDS epidemic

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to Chicagoland and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with the greater knowledge and skills. [More]

BAI-led #KnowBetterDoBetter movement comes to Broward County to eliminate HIV/AIDS

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to Broward County and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with greater knowledge and skills. [More]

National #KnowBetterDoBetter movement comes to Bay Area to eliminate HIV and AIDS

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to the Bay Area and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with greater knowledge and skills. [More]

National #KnowBetterDoBetter movement comes to Charlotte, NC to eradicate HIV/AIDS

The national #KnowBetterDoBetter movement led by the Black AIDS Institute (BAI) is coming to Charlotte, NC and the message is loud and clear- we can end the AIDS epidemic if we fully engage non-medical workers on the frontline of the battle with greater knowledge and skills. [More]

HIV science and treatment knowledge can end AIDS epidemic in the US

The scientific evidence is clear. As a result of extraordinary advances in biomedical research, we now have the tools we need to end the HIV epidemic in the United States. Or do we? [More]
Hikma prepares to launch colchicine 0.6mg capsules in the US market

Hikma prepares to launch colchicine 0.6mg capsules in the US market

Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, today notes that Takeda Pharmaceuticals U.S.A. Inc. has been unsuccessful in appealing the decision by the United States District Court for the District of Delaware to deny Takeda's motion for a preliminary injunction in relation to the distribution of Hikma's colchicine 0.6mg capsules for the prophylaxis of gout flares in adults. [More]
Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Crealta Pharmaceuticals LLC, today announced that the Journal of Clinical Rheumatology published a comprehensive review of a post-hoc safety analysis that was completed for Krystexxa (pegloticase), including data from the two pivotal randomized Phase III trials and one open-label extension trial. [More]
NTU scientists discover how malaria parasite develops resistance towards front-line drugs

NTU scientists discover how malaria parasite develops resistance towards front-line drugs

Scientists from Nanyang Technological University have discovered exactly how the malaria parasite is developing resistance towards the most important front-line drugs used to treat the disease. [More]
Simple rectal swab cultures can thwart drug-resistant E. coli in patients undergoing TRUSBx procedures

Simple rectal swab cultures can thwart drug-resistant E. coli in patients undergoing TRUSBx procedures

Some infections after prostate biopsy due to drug-resistant Escherichia coli can be thwarted by simple rectal swab cultures prior to the procedure. The cultures test for antibiotic-resistant E. coli, and the findings are used to direct the selection of antimicrobial prophylaxis used for the procedure, according to Rhode Island Hospital researchers. [More]