We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
The FDA has adopted the final version of an International Conference for Harmonisation (ICH) guidance on the validation of bioanalytical methods and studies. Read More
The Centers for Disease Control and Prevention (CDC) has revamped its recommendations for prescribing opioids, nixing controversial dose and duration limits from 2016 that critics say hurt patients who needed opioids. Read More
The Orphan Drug designation is for drug or biological products to prevent, diagnose or treat rare diseases or conditions that affect fewer than 200,000 patients in the United States. Read More