A U.S. appeals court panel has said no to resurrecting a 2019 lawsuit alleging that AbbVie broke antitrust laws by using a “patent thicket” to cover its blockbuster monoclonal antibody Humira…
Generics makers will soon have the option to submit expedited safety reports electronically to the FDA Adverse Event Reporting System (FAERS), according to a new draft guidance that provides instructions…
Johnson & Johnson (J&J) disclosed that it has pursued arbitration against beleaguered vaccine manufacturer Emergent BioSolutions for alleged breach of contract. Source: Drug Industry Daily
More than 100 West Virginia cities and counties have reached a $400 million settlement with drug distributors McKesson, AmerisourceBergen and Cardinal Health, resolving allegations that the companies recklessly oversupplied West…
Gilead Sciences’ Biktarvy, a three-component antiviral, suppressed HIV infections in 99 percent of patients who took it as part of two phase 3 studies. There were no treatment failures, the…
Sanofi has failed to convince a federal appeals court that Viatris monopolized the market for injected epinephrine through anticompetitive pricing for its EpiPen. Source: Drug Industry Daily
Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine…
After less than stellar interim results from a phase 3 trial focused on head and neck cancer, AstraZeneca is calling it quits in the indication for the checkpoint inhibitor it…
Recognizing that a lack of standard methods is the primary challenge to widespread manufacturing of cell and gene therapies, two groups are aiming to lower the barrier by bringing best…
Massachusetts-based Editas Medicine announced that the FDA has removed a partial clinical hold on its trial of EDIT-301 (AsCas12a), its experimental gene treatment for severe sickle cell disease. Source: Drug…