“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office.
The existence of two approved therapies, Lumakras (sotorasib, Amgen Inc.) and Karzati (adagrasib, Mirati Therapeutics Inc.), has been a triumphant success against KRAS, a protein that was once considered undruggable.
The existence of two approved therapies, Lumakras (sotorasib, Amgen Inc.) and Karzati (adagrasib, Mirati Therapeutics Inc.), has been a triumphant success against KRAS, a protein that was once considered undruggable. KRAS is the most frequently mutated oncogene in solid tumors. KRAS driver mutations are found in about 30% of non-small-cell lung cancers (NSCLC), about half of colorectal cancers, and more than 90% of pancreatic cancers. Lumakras and Karzati both target the G12C mutation. Inhibitors that target other mutations, like G12D, are now making their way through preclinical and clinical development, while some companies are developing therapies that would target mutated KRAS more broadly, irrespective of the specific mutation that is activating the protein.
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.
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 U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
Limited data exist on checkpoint inhibition that targets the early activation phase of adaptive immunity. B-and T-lymphocyte attenuator (BTLA) blockade is known to enhance and broaden CD8+ T-cell responses to a target antigen.
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
Two companies who needed partners have found each other, as privately held Elicio Therapeutics Inc. will merge with Angion Biomedica Corp. in an all-stock deal.
