For people living with HIV, the single greatest achievement to date has been the emergence of antiretroviral treatments (ART) that completely block the virus, resulting in reduced mortality and morbidity and improved quality of life. But taking one pill a day for life cannot be the end of this journey, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. Even with the success of ART, drug adherence remains a problem due to pill fatigue or depression and other mental health conditions, as well as drug-drug interactions, said Claudia Cortes, associate professor at the University of Chile in Santiago. New drugs that are longer lasting, more convenient, and affordable are desperately needed, she said.
Although huge strides have been made with antiretroviral therapy (ART) and prevention since HIV was first reported 42 years ago, there is still not an effective preventive vaccine or a scalable cure for those living with HIV. But broadly neutralizing antibodies (bNAbs) look to be a further step down the pathway to a cure, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia.
The HIV journey is a roller coaster of highs and lows for the patients living with HIV and their families and loved ones but also for the community of researchers and clinicians who pour their hearts and souls into the work they do, said speakers at the International AIDS Society (IAS) 2023 conference in Brisbane, Australia.
Vir Biotechnology Inc. said it won’t be discussing further the phase II data from the influenza A prevention study called Peninsula until the company’s second-quarter earnings update Aug. 3, and a closer look at the results has yet to decide the fate of monoclonal antibody VIR-2482, which missed its primary and secondary endpoints.
Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market.
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
In a move to address both prevention and treatment of hepatitis B virus (HBV), Brii Biosciences Ltd. has acquired from VBI Vaccines Inc. a global exclusive license to HBV therapeutic vaccine BRII-179 (VBI-2601) and an exclusive license for HBV prophylactic vaccine Prehevbri in the Asia Pacific region, excluding Japan.
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