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Boehringer Ingelheim seeks FDA approval for Pradaxa to treat DVT and PE

Boehringer Ingelheim seeks FDA approval for Pradaxa to treat DVT and PE

Legal-Bay LLC, The Lawsuit Settlement Funding Company, announced today that Pradaxa's maker, Boehringer Ingelheim Pharmaceuticals, is seeking FDA approval for its blood thinner to treat DVT and PE. [More]
Acacia Pharma begins APD421 Phase 3 study in combination with standard anti-emetics for PONV

Acacia Pharma begins APD421 Phase 3 study in combination with standard anti-emetics for PONV

Acacia Pharma Ltd, the supportive care company developing products for US and international markets, announces the initiation of a Phase 3 study investigating APD421 in combination with standard anti-emetics, in the prevention of post-operative nausea & vomiting (PONV) in high-risk patients. PONV remains a clinically significant problem in patients undergoing surgery, despite the availability of a range of anti-emetic medications. [More]
Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Baxter submits BAX 855 NDA to Japan's MHLW for treatment of hemophilia A patients

Nektar Therapeutics reported today that partner Baxter International Inc. announced that the company has submitted a new drug application (NDA) to Japan's Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment based on ADVATE [Antihemophilic Factor (Recombinant)] for patients over 12 years of age with hemophilia A. [More]
US health care providers reluctant to prescribe HIV prevention plan

US health care providers reluctant to prescribe HIV prevention plan

Many health care providers across the United States may be reluctant to prescribe an increasingly important prevention approach to some of their patients who are at substantial ongoing risk for HIV. [More]
Researchers reveal obstacles that prevent Ugandans with RHD from getting life-saving penicillin

Researchers reveal obstacles that prevent Ugandans with RHD from getting life-saving penicillin

Penicillin has nearly eradicated rheumatic heart disease (RHD) in the United States. But 15 million people still suffer with the disease worldwide, and 1.4 million die each year, according to World Heart Federation. [More]
Novo Nordisk announces U.S. launch of Novoeight for people living with hemophilia A

Novo Nordisk announces U.S. launch of Novoeight for people living with hemophilia A

Novo Nordisk today announced the company will launch Novoeight (Antihemophilic Factor [Recombinant]) in the United States for people living with hemophilia A. [More]
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

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]
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