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In the ongoing saga of the Pasteur Act — a thus-far unsuccessful bill introduced in 2020 to encourage new treatments for fighting drug-resistant pathogens — a group of academics and advocacy organizations sent a letter to Congress contending that the “fatally flawed” bill would squander taxpayer dollars and may exacerbate the threat of antibiotic resistance in the U.S. rather than fix it. Read More
GSK’s Blenrep (belantamab mafodotin), an antibody-drug conjugate that won accelerated approval in 2020, has failed its required confirmatory study as a treatment for relapsed or refractory multiple myeloma (RRMM), missing its primary endpoint. Read More
In the latest twist in an ongoing patent case with far-reaching implications, the U.S. Supreme Court will consider Amgen’s petition seeking review of an appeals court decision that invalidated the company’s patent for its blockbuster cholesterol drug Repatha (evolocumab). Read More
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data. Read More
The FDA handed Lupin a warning letter citing the company’s failure to correct cross-contamination issues noted in an inspection of its manufacturing plant in Palghar, India, earlier this year. Read More