In the latest skirmish over who can get the 340B discounts on prescription drugs that are supposed to help qualifying U.S. providers offer charity care, the Pharmaceutical Research and Manufacturers of America (PhRMA) is challenging a recently passed Arkansas law that seeks to regulate drug manufacturers’ participation in the federal drug pricing program.
Low-grade gliomas with mutated isocitrate dehydrogenase-1 (IDH1) produced and secreted higher levels of the cytokine granulocyte colony-stimulating factor (G-CSF) than other glioma types, which improved their antitumor immune response in animal models.
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.
The FDA unveiled a draft guidance addressing the responsibilities of clinical investigators for safety reporting for investigational drugs and devices, a novel attempt to combine the disparate adverse event reporting timelines for investigational drugs and devices.
As part of its real-world evidence (RWE) program, the U.S. FDA is issuing a draft guidance on using electronic health records and medical claims data in clinical trials to support a drug’s safety and effectiveness.
When the White House COVID-19 Response Team announced its booster program in August, it justified the broad use of a third vaccine dose with antibody studies and real-world data from Israel.
Biopharma companies that have agreed to pay the U.S. Department of Justice millions of dollars to resolve allegations that they illegally used charities to cover patients’ Medicare copays for brand drugs are finding those settlements may be just the beginning of their legal woes, even when the companies admit no liability in the settlement.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks.
858 Therapeutics Inc. emerged from stealth mode, unveiling $60 million in series A funding and plans to drug a series of protein targets involved in modulating RNA biology in cancer.
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