Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?
At the end of June, the FDA sent a Notice of Violation (NOV) letter to Dr. C (you can find his name in the letter), Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).Here's the ad in question:Unless Dr. C (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C...
Source: Pharma Marketing Blog - July 8, 2014 Category: Pharma Commentators Tags: 14 letters FDA Girl from Google Legal/Regulatory Source Type: blogs
New CDC Guidelines: People at Risk for HIV Should Consider Truvada PrEP
Healthcare providers should advise people at "substantial risk" for HIV infection about pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine, or Truvada, according to new guidelines issued by the U.S. Centers for Disease Control and Prevention (CDC). This includes HIV negative people in an ongoing sexual relationship with HIV positive partners, gay or bisexual men who have had (Source: Nelson Vergel's HIV Blog)
Source: Nelson Vergel's HIV Blog - May 28, 2014 Category: HIV AIDS Authors: Nelson Vergel Source Type: blogs
MKSAP: 33-year-old woman with whitish spots in the mouth and throat
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians.
A 33-year-old woman is evaluated for a 5-week history of whitish spots in the mouth and the back of the throat and discomfort with swallowing solid foods. This is her first episode of these symptoms. She has had no mouth pain, trouble ingesting liquids or pills, nausea, vomiting, diarrhea, fever, chills, sweats, or skin problems. She has a 3-year history of HIV infection and also has moderately severe asthma, which is now well controlled with inhaled medications that were recently prescribed. Her medications are...
Source: Kevin, M.D. - Medical Weblog - December 1, 2013 Category: Family Physicians Tags: Conditions Infectious disease Source Type: blogs
Anti-Retroviral Intravaginal Ring Very Promising in Preventing HIV Infection
Vaginal gels containing the anti-retroviral drug tenofovir seemed promising at first in preventing HIV infection, but failed during trials because of poor delivery. Now an intra-vaginal ring that slowly dispenses the drug has been shown effective in controlling simian immunodeficiency virus (SHIV) in macaque monkeys. The TDF-IVR (tenofovir disoproxil fumarate intravaginal ring) has shown complete control in preventing SHIV transmission over a four month period with monthly ring changes. All the monkeys that had the ring and were exposed to the virus remained SHIV negative, while the control group was essentially comple...
Source: Medgadget - October 2, 2013 Category: Technology Consultants Authors: Editors Tags: Medicine Ob/Gyn Source Type: blogs
China Revokes Patent On Gilead AIDS Drug Over Pricing
In the latest row between global drugmakers and governments over affordable medicines, China's State Intellectual Property Office revoked the patent on Viread, a drug sold by Gilead Sciences for treating HIV/AIDS and hepatitis B, after a challenge by Aurisco, the largest manufacturer of active pharmaceutical ingredients in the Asian country, BioWorld writes.
The rational for the move was that the Viread patent lacked novelty and was not entitled to protection, China health analyst Robert McTiernan of IHS Healthcare told the paper. And in this instance, the decision means that, unlike when a government issues a compulsory l...
Source: Pharmalot - August 6, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
China nixes patent for Gilead HIV, hepatitis drug Viread
Gilead Chairman and CEO John Martin.The patent protecting Gilead Sciences Inc.'s HIV and hepatitis B drug Viread has been revoked by China officials.The move, explained BioWorld, gives China greater leverage in ongoing negotiations with drug companies around pricing. For Gilead, it is another strike against Viread, which also has had its patent protection reversed in India and Brazil."It is a fairly groundbreaking decision," China health analystRobert McTiernan of IHS Healthcare told BioWorld. "The big trend is that (China wants) pharma companies to be more flexible on pricing. They will likely be able ...
Source: PharmaGossip - August 3, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Prevention In A Pill: Gilead Med Lowers HIV Risk In Injectable Drug Users
This study completes the picture of PrEP efficacy for all major HIV risk groups,” says principal investigator Michael Martin, chief of clinical research for the Thailand Ministry of Public Health–US CDC Collaboration, in a statement. “We now know (PrEP) can be a potentially vital option for HIV prevention in people at very high risk for infection, whether through sexual transmission or injecting drug use.”
“Injection drug use accounts for a substantial portion of the HIV epidemic around the world and we are hopeful that PrEP can play a role in reducing the continued toll of HIV infection in this population,” sa...
Source: Pharmalot - June 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot… Pharmalittle… Good Morning
Rise and shine, everyone, another busy day is on the way. We, however, have something of a respite this morning, if only because the local schoolhouses are closed this week, which means the short people are sleeping in. As a result, we have more time to devote to rummaging for fascinating developments. This calls for celebration, so please join us as we hoist another cup of stimulation and dig in for another interesting session. Hope your own goes well and you conquer the world. Meanwhile, do stay in touch…
Almost One-Third Of Chemotherapies Are Used Off-Label: Study (Reuters)
US Deaths From Overdoses Up For 11th Con...
Source: Pharmalot - February 20, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Allergan Botox Chemotherapy Gilead Sciences GlaxoSmithKline Isis Pharmaceuticals JJ Johnson & Johnson Off-Label Overdose Peregrine Pharmaceuticals Takeda Pharmaceuticals Teva Pharmaceuticals Vaginal Mesh Implants Source Type: blogs
Recent Studies Show Concerns With The Use of Tenofovir (Viread), Popular Drug in HIV Treatment
This study let us know that NRTI drugs, already known for causing the damage to mitochondrial DNA that leads to peripheral neuropathy, fat loss and some other side-effects, also exert an effect on cellular DNA, and that in this case tenofovir may be the drug to keep an eye on.
Telomerase shortening is, by definition, a side-effect that won’t (Source: Nelson Vergel's HIV Blog)
Source: Nelson Vergel's HIV Blog - February 4, 2013 Category: HIV AIDS Authors: Nelson Vergel Source Type: blogs
