• Received a 483? The Clock is Ticking.

    Updated: 2012-07-31 12:12:52
    If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast.  With new agency enforcement policies in action since 2009, companies are expected to respond to 483s within 15 business days.  What's the ...

  • Biopharma Manufacturing Partnerships

    Updated: 2012-07-31 12:12:52
    Tomorrow opens the Biopharmaceutical Manufacturing Partnerships conference in Philadelphia, in coordination with CBI and Pharmaceutical Technology magazine. Experts are expected to speak on number of key outsourcing issues including effective due diligence, good procurement practices, QbD implementation, tech transfer strategies, and emerging business models. I'll be there as will be Patricia ...

  • USP Highlights Excipient Performance

    Updated: 2012-07-31 12:12:52
    It’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients. But their importance in drug formulation and in ensuring final product quality has been gaining recognition over the past few years, unfortunately due to some ...

  • Increased Generics Spending in Pharmerging Markets Predicted

    Updated: 2012-07-31 12:12:52
    The pharmerging nations are expected to nearly double their spending on medicine by 2016, according to an IMS Institute for Healthcare Informatics report, The Global Use of Medicines: Outlook through 2016, the Institute said in a press release. The report lists the pharmerging nations as: China, Brazil, India, Russia, ...

  • On the sidelines: Lisa Fitzpatrick on fighting AIDS in America

    Updated: 2012-07-30 17:53:27
    Dr. Lisa Fitzpatrick is medical director of the Infectious Diseases Care Center at United Medical Center in Washington,D.C., and now  has about 100 HIV-positive patients. From 2005 to 2007, she also was the Centers for Disease Control and Prevention chief of party for the Caribbean. She spoke at several events in and around the conference, [...](Read more...)

  • Conversations from AIDS 2012: Ron Valdiserri and Terrance Moore on Addressing HIV Disparities Among Black Gay & Bisexual Men

    Updated: 2012-07-30 17:44:49
    Editor’s Note: We had opportunities to catch up with so many great partners on so many important issues while at the XIX International Conference on AIDS (AIDS 2012) last week, we’ll continue bringing you interviews this week and next. In this conversation from AIDS 2012, Dr. Ron Valdiserri, Deputy Assistant Secretary for Health, Infectious Diseases...

  • HIV/AIDS in the Nation’s Capitol

    Updated: 2012-07-27 22:25:15
    On Tuesday, Whitman Walker Health Center of Washington, DC, hosted “Return to Lisner: A Forum on HIV/AIDS” to discuss the current state of the HIV/AIDS epidemic. The event marked the 29th anniversary of DC’s first HIV/AIDS forum at George Washington University’s Lisner Auditorium. Jeanne White-Ginder, the mother of Ryan White, an Indiana teenager who died...

  • Hopes Raised by HDAC Inhibitor, but Uncertainties Remain

    Updated: 2012-07-27 21:33:00

  • USG @ AIDS 2012 Video: Dr. Koh with Dr. Kevin Fenton

    Updated: 2012-07-27 21:30:28
    At the XIX International AIDS Conference (AIDS 2012) , Assistant Secretary for Health Dr. Howard Koh sat down with Dr. Kevin Fenton to discuss the U.S. Centers for Disease Control and Prevention’s (CDC) new “high-impact prevention” approach to HIV. Dr. Fenton is Director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB...

  • USG @ AIDS 2012: How to Talk About a “Cure”

    Updated: 2012-07-27 21:05:31
    In an interview with AIDS.gov Director Miguel Gomez, Dr. Carl Dieffenbach discussed how to talk about “a cure” for HIV, and how talk of a cure is different from talk of an “AIDS-free generation.” Dr. Dieffenbach is Director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases (NIAID). According to...

  • AIDS 2012 and the Road Ahead

    Updated: 2012-07-27 18:30:51
    Today is the last day of AIDS 2012, the first International AIDS Conference to be held in the United States in more than 20 years. AIDS 2012 helped crystallize the extraordinary opportunities—and serious challenges—that lie ahead as we work to bring about an AIDS-free America. Since the last International AIDS Conference was held in the United...

  • USG @ AIDS 2012 Video: Phill Wilson and Miguel Gomez

    Updated: 2012-07-27 17:19:33
    In his remarks at the Monday plenary of the XIX International AIDS Conference (AIDS 2012), Phill Wilson, Founder and Executive Director of the Black AIDS Institute and member of the Presidential Advisory Council on HIV/AIDS, gave delegates an update on the epidemic in the United States. “We are at a deciding moment in the trajectory...

  • Subsequent HPTN 052 data shows early HIV treatment is even more beneficial to patient, cost-effective

    Updated: 2012-07-27 16:47:15
    The good news keeps getting better for the HIV Prevention Trials Network (HPTN) 052 study, which found last year that HIV-infected persons on antiretroviral therapy (ART) were 96 percent less likely to transmit the virus to an uninfected partner through vaginal sex. At the International AIDS Conference (IAC) in Washington this week, two late-breaker sessions [...](Read more...)

  • World Hepatitis Day

    Updated: 2012-07-27 14:00:03
    Tomorrow, July 28, we will join the global observance of World Hepatitis Day.  Organized by the World Hepatitis Alliance , a non-governmental organization that represents hepatitis B and hepatitis C patient groups from around the world, the annual observance focuses attention on the huge impact of viral hepatitis infection globally – with as many as one...

  • HIV/AIDS funding reality check: Tanzanias of the world can’t do it alone

    Updated: 2012-07-27 04:16:57
    In Tanzania, an east African country home to 46.2 million people where the national HIV/AIDS prevalence rate is 5.7 percent, the domestic HIV/AIDS response accounts for 10 percent of the national budget, or about $20 million per year. Sixty-five percent of government funding finances antiretroviral therapy (ART). Still, there is a gap of financing of [...](Read more...)

  • Community based groups note risks, seize opportunities social media offer sexual minorities

    Updated: 2012-07-27 01:54:05
    Driven underground by laws and discrimination, their needs for information ignored in much of the global AIDS response, social media provided a refuge but also risks for members of sexual minorities in countries around the world, panelists agreed Thursday. But, representatives of groups from Thailand, the Netherlands, Morocco and Cameroon said, social media and communications [...](Read more...)

  • USG @ AIDS 2012 Video: Dr. Koh and A. Toni Young

    Updated: 2012-07-26 23:26:02
    In the latest interview from the Conversations from AIDS 2012 series, Assistant Secretary for Health Dr. Howard Koh speaks with A. Toni Young, Executive Director of the Community Education Group (CEG) in Washington, D.C. Ms. Young discusses CEG’s massive testing program focusing on heterosexual African-Americans living in the District and the program’s involvement in HPTN...

  • The future of the AIDS response: A fragile affair

    Updated: 2012-07-26 22:04:39
    “The 1,200 wealthiest people in the world have about $4.2 trillion in wealth,” said Kent Buse, a senior advisor on policy and strategy at UNAIDS. If that super elite group contributed 0.1 percent of their wealth, he said, it would pay for all of global health. Buse opened what was a sobering discussion about the [...](Read more...)

  • AIDS 2012: HIV in Gay and Bisexual Men

    Updated: 2012-07-26 21:00:49
    The impact of the HIV epidemic on gay, bisexual, and other men who have sex with men (MSM) around the world has received considerable attention at the XIX International AIDS Conference (AIDS 2012). The Lancet (the British medical journal) distributed a special issue on MSM across the globe to more than 20,000 conference attendees. The...

  • Antiviral Activity of Virus-Specific CD8 T Cells Linked to Rate of CD4 T Cell Decline in HIV Infection

    Updated: 2012-07-26 20:00:50

  • USG @ AIDS 2012 Video: Dr. Koh and Ambassador Goosby

    Updated: 2012-07-26 19:30:22
    The XIX International AIDS Conference (AIDS 2012) is the largest meeting of individuals from around the world working to end the HIV/AIDS pandemic. In this video interview, Dr. Howard Koh, Assistant Secretary for Health at the U.S. Department of Health and Human Services talks with Ambassador Eric Goosby, U.S. Global AIDS Coordinator, about how the...

  • Congressional leaders say bipartisanship, enthusiasm are key to continued AIDS support on the Hill

    Updated: 2012-07-25 23:24:16
    Despite much disruption from protesters – to the visual and audible discontent of event moderator and former Senate Majority Leader Bill Frist (R-TN) – U.S. Congressional leaders were able to get the point across Tuesday that in order to defeat AIDS support must come from both sides of the aisle on Capitol Hill. Rep. Barbara [...](Read more...)

  • NIDA grants $5 million to pursue combo anti-heroin and HIV vaccine

    Updated: 2012-07-25 22:37:07
    It sounds like a fantasy, but researchers are making headway in the development of an effective, safe and easily manufactured combination anti-heroin/HIV vaccine. The National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) has chosen Gary R. Matyas, PhD, to receive the NIDA Avant-Garde Award for Medications Development – a $1 [...](Read more...)

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