Karuna Therapeutics’ investigational schizophrenia drug KarXT (xanomeline-trospium) reduced symptoms of the disorder in a late-stage study, with clinically meaningful changes seen within two weeks of beginning treatment. Source: Drug Industry…
Regeneron Pharmaceuticals has sued Viatris over the company’s proposed biosimilar of Regeneron’s blockbuster vision loss drug, saying it violates multiple patents. Source: Drug Industry Daily
Data from an ongoing phase 3 study show the investigational PD-L1 antibody sugemalimab buys an extra four months of progression-free time for patients with unresectable stage III non-small cell lung…
Pfizer’s proposed copay assistance program for its $225,000-a-year heart treatment would violate the Federal Anti-Kickback Statute (AKS). Source: Drug Industry Daily
The Pharmaceutical Research and Manufacturers of America (PhRMA) is incensed about the reconciliation bill the Senate passed on Sunday night, which would permit the government to negotiate with drugmakers on…
Pfizer announced that it will pay $5.4 billion for Global Blood Therapeutics (GBT), manufacturer of Oxbryta (voxelotor), one of a handful of drugs for treating sickle cell anemia. Source: Drug…
FDA has approved Enhertu (fam-trastuzumab-deruxtecan-nxki), the first approved therapy targeted to patients with unresectable or metastatic HER2-low breast cancer subtype, a newly defined subset of HER2-negative breast cancer. Source: Drug…
Only 45 percent of cancer drug trials made their individual participant data (IPD) available to other qualified researchers over the past 10 years, according to a new study. Source: Drug…
After more than a year of missed opportunities, Senate Democrats yesterday passed a landmark, $740 billion reconciliation bill that would grant Medicare the authority to negotiate the price of prescription…
The FDA issued a warning letter to over-the-counter (OTC) drug manufacturer DSP Skin Care for quality lapses at its facility in Los Angeles, Calif., noting that the company had failed…