Integrase strand transfer inhibitors (INSTI) under a once-daily oral schedule are the standard-of-care treatment for HIV. Longer-acting oral and injectable formulations to facilitate adherence to treatment regimens are needed.
As developers in the oft-troubled TIGIT class forge onward, Roche Holding AG’s Genentech unit provided an unfavorable update July 5 on the phase II/III Skyscraper-06 study testing anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer (NSCLC).
Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.
Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation.
Cartography Biosciences Inc. announced it has entered into a multiyear, strategic collaboration agreement with Gilead Sciences Inc. to discover and develop therapies for patients with triple-negative breast cancer and adenocarcinoma.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Gilead Sciences Inc. has patented 4'-Thionucleoside analogues acting as viral replication inhibitors reported to be useful for the treatment of HIV infection.
