SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi.
Merck & Co. Inc. has reported the development of a novel monobactam for use in combination with its class A/C β-lactamase inhibitor (BIL) relebactam (MK-7655) in order to achieve the broadest activity against multidrug-resistant (MDR) gram-negative pathogens that express a variety of β-lactamases. The in vitro efficacy of the combination of the monobactam – MSD-045934942 – against a panel of MDR and non-MDR gram-negative bacteria was evaluated using in vitro broth microdilution testing.
The floodgates have opened for challenges to the new U.S. drug price negotiation process laid out in the Inflation Reduction Act (IRA) that was narrowly passed last year.
Bristol Meyers Squibb Co. (BMS) joined the Inflation Reduction Act (IRA) pile-on June 16, filing a third constitutional challenge to the U.S. Medicare drug price negotiations mandated in the law that was narrowly passed last year on a partisan vote.
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year.
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
As Merck & Co. Inc.’s whopper proposal to take over Prometheus Biosciences Inc. for $10.8 billion faded from the ever-churning headlines, officials of the pharma heavyweight set about answering questions with regard to plans for the newly gained PRA-023, a humanized monoclonal antibody that targets tumor necrosis factor-like ligand 1A (TL1A).
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the WHO is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions.
