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Trials of drugs to treat cancer in the central nervous system (CNS) that has metastasized from solid tumors outside the CNS should examine whether the treatment controls the cancer at all disease sites, according to an FDA draft guidance released Wednesday. Read More
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Read More
The Department of Justice (DOJ) has charged a Teva Pharmaceuticals subsidiary with allegedly conspiring to rig prices for generic drugs, making it the seventh drugmaker to be indicted as part of an ongoing probe. Read More
Partner Therapeutics has enrolled the first patient in a phase 2 trial evaluating its inhaled Leukine (sargramostim) for hospitalized COVID-19 patients. Read More
Three ranking Democrats have asked a Virginia-based consulting firm to reveal details of its government contract for Operation Warp Speed’s chief adviser Moncef Slaoui, citing concerns that the contract allows the former pharma executive to skirt ethics rules and avoid disclosing potential conflicts of interest. Read More
Moderna’s coronavirus vaccine candidate was well-tolerated and worked well in elderly COVID-19 patients in a small, early-stage trial, the company said Wednesday, following promising results announced in July for younger patients. Read More
A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Read More
The National Institutes of Health (NIH) said it plans to study an investigational antiviral from Gilead Sciences that proponents believe may offer significant advantages over remdesivir as a possible COVID-19 treatment. Read More
AstraZeneca has dosed the first participants in a phase 1 trial of its investigational monoclonal antibody product AZD7442 for preventing and treating COVID-19. Read More