Articles tagged with: Janssen Therapeutics
Norvir Prescribing Information Updated To Include Risk Of Life-Threatening Skin Condition – The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Norvir (ritonavir) to warn of the possibility of toxic epidermal necrolysis, a rare, life-threatening reaction to medications in which the top layer of skin detaches from the bottom layer and dies. The new prescribing information also notes that when Norvir is taken with the cancer drugs Tasigna (nilotinib) or Sprycel (dasatinib), used to treat certain forms of leukemia, or the painkiller fentanyl (Duragesic, Actiq), dose adjustments of these drugs may be necessary. For more information, please see the FDA press release.
Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.
GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.
Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.
Tibotec Pharmaceuticals and Gilead Sciences have agreed to develop a new once-daily combination antiretroviral pill that combines the protease inhibitor Prezista with the investigational booster cobicistat.
In addition, the companies are currently in negotiations to develop a second pill combining Prezista, cobicistat, Emtriva, and an investigational new form of Viread called GS 7340.
“We are excited to be able to study and develop Prezista with an alternative boosting agent in a combination product which has the potential to reduce the number of tablets patients take,” said Dr. Johan Van Hoof, …
Texas AIDS Drug Assistance Program Faces Budget Shortfall – The Texas AIDS Drug Assistance Program has failed to secure additional funding and will face budget shortages starting in September 2012. State officials have said that they will likely implement cost-cutting measures, such as excluding more expensive HIV drugs and asking pharmaceutical companies for discounts, to mitigate the shortages. The Texas legislature had previously decided not to give the program an additional $19 million to prevent cutbacks (see related AIDS Beacon news), instead deciding that the program could receive additional funds from the state’s Medicaid budget if needed. However, Medicaid also faces a $4.8 billion shortfall, making such assistance unlikely. For more information, please see the Associated Press article.
GeoVax Adds Los Angeles Site To Phase 1 Trial Of Therapeutic HIV Vaccine – Biotechnology company GeoVax Labs has announced that it is adding a third location, in Los Angeles, to its Phase 1 trial of a therapeutic vaccine to treat HIV. The first two sites are in Atlanta and Birmingham, AL. The trial is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. GeoVax expects to enroll 10 participants. For more information, please see the GeoVax press release or the U.S. Clinical Trials Registry.
Tibotec Therapeutics Changes Name To Janssen Therapeutics – Tibotec Therapeutics, the maker of the HIV drugs Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine), has changed its name to Janssen Therapeutics. The name change is an attempt to create a common link between all of the Janssen companies, which are subsidiaries of Johnson & Johnson and include Janssen Pharmaceuticals and Janssen Biotech. The company’s new website includes links to information on its antiretrovirals and patient assistance programs to help low-income patients pay for the drugs. For more information, please see the Johnson & Johnson press release or the Janssen Therapeutics website.
Reminder: Free HIV Testing Today – As part of National HIV Testing day, many locations nationwide will offer free HIV testing today (see related AIDS Beacon news). To find a testing location, please see the Centers for Disease Control’s National HIV Testing Day website.