Avadel Specialty Pharmaceuticals called on the FDA to deny approval for certain demopressin acetate treatments for nocturia, including a pending drug application by Ferring, expressing concern over the pharmaceutical company’s…
New guidance from the FDA on bioanalytical method validation revises a 2013 document with expanded principles and new appendices on documentation and acceptance criteria. Source: Drug Industry Daily
Clinical trials for acne drugs should limit efficacy assessments to patients’ faces and assess results based on a drug’s effect on the number of lesions and the lesions’ severity, the…
Novartis and Par Pharmaceutical were hit with a pay-for-delay lawsuit filed by Puerto Rican drug manufacturer Drogueria Betances alleging the two companies engaged in years of anticompetitive conduct that delayed…
The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Source: Drug Industry Daily
Sponsors of trials for drugs to prevent cytomegalovirus (CMV) infection in transplantation should use incidence of disease within 6 to 12 months post-transplantation as their primary endpoint, according to new…
Allergan’s contested patents for the dry-eye drug Restasis took another potential hit last week as four major retailers filed an antitrust lawsuit against the drugmaker. Source: Drug Industry Daily
The FDA issued an alert to clinical investigators, doctors and consumers about safety issues associated with use of Keytruda or Tecentriq as a monotherapy in oncology clinical trials. Source: Drug…
The FDA finalized guidance outlining clinical trial designs for hypogonadotropic hypogonadism treatments, recommending efficacy endpoints and enrollment criteria. Source: Drug Industry Daily
Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new…