With the July 25 PDUFA priority review date looming for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic anal cancer, the FDA has one voting question for its Oncologic Drugs Advisory Committee (ODAC): Should it hold off on its approval decision until more data are in from a phase III study?
Curing HIV remains a dream for now, but it is clearly not a pipe dream. One of the challenges for developing a vaccine is that there is no natural immune response to model such a vaccine on. Over time, an untreated HIV infection will almost certainly kill its host. However, there is a group of elite controllers – people who, although they cannot eliminate the virus, manage to keep it in check.
In 2020, the Conference on Retroviruses and Opportunistic Infections (CROI) was the first medical conference to go virtual, with two days advance warning, when news of infections resulting from a Biogen Inc. conference with about 150 attendees made it abundantly clear that SARS-CoV-2 was circulating, well, probably everywhere.
Excision Biotherapeutics Inc.’s CEO is specific when he talks about his company’s therapies and what they may achieve: a functional cure. “When you treat someone and they become cancer free, you can’t use the world ‘cured’ because the cancer may come back decades later,” Daniel Dornbusch told BioWorld. “But you can talk about a functional cure, meaning the cancer didn’t come back for a very long time. It’s functionally cured for maybe 10, 20 or 30 years."
CAJICA, Colombia – A phase III trial for an HIV vaccine developed Janssen Vaccines & Prevention BV is finally moving forward in Latin America and elsewhere in the world after a delay of more than a year caused by slow regulatory progress and worsened by a string of COVID-19 lockdowns.
Despite challenges tossed at the phase III study of mitapivat from Agios Pharmaceuticals Inc. by COVID-19, top-line data showed the oral therapy hit its primary endpoint in treating adults with pyruvate kinase (PK) deficiency who don’t receive regular transfusions.
It didn’t take long for a U.S. district judge to grant Gilead Sciences Inc.’s request for a temporary restraining order to stop two interconnected health care networks in Florida from defrauding the company’s Advancing Access Medication Assistance Program that provides free HIV pre-exposure prophylaxis drugs to eligible, uninsured people.
Researchers at the University of Virginia have used a retrospective database analysis to show that the use of nucleoside reverse transcriptase inhibitors for the treatment of HIV or hepatitis B reduced the risk of developing type 2 diabetes by 33%.
The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human deficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.
With COVID-19, questions about how infections cause lasting immunity, or don’t, and how you know and what it all means for vaccines have become a matter of public focus. But some immunologists have been pondering those questions for years. “The immune system has a very good memory,” Bali Pulendran told BioWorld. “Clearly, some viruses and some pathogens can enter the body and stimulate the immune system, and the immune system can remember that encounter for decades.”
