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Drugmakers that are obtaining biotechnology-derived proteins in the EU should include effective evaluation and verification studies in their process validation documentation, the European Medicines Agency says. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to the European Medicines Agency verifying that the information used to gain marketing authorization remains valid in practice. Read More
Boehringer Ingelheim (BI) will spend $650 million to settle approximately 4,000 state and federal lawsuits alleging the drugmaker didn’t do enough to warn patients about the hazards of its blockbuster blood thinner Pradaxa. Read More
The FDA wants vaccinemakers to begin making adverse events reports electronically, and is launching a pilot study to assess whether its Adverse Event Reporting System is adequate for vaccine reports. Read More
Two California counties sued five drugmakers, alleging they improperly promoted addictive painkillers for chronic pain management, the latest localities to target opioid manufacturers as a way to combat abuse. Read More
A Las Vegas jury has found Takeda Pharmaceutical not liable for the bladder cancer of two women who took the Japanese drugmaker’s diabetes drug Actos, marking the firm’s fifth legal victory out of six cases that have gone to trial so far. Read More
International and U.S. authorities this week seized more than $31 million in potentially counterfeit and dangerous drugs and shut down more than 10,600 websites for peddling unapproved and substandard pharmaceuticals in the third annual international sweep of its kind. Read More
The FDA blasted generic drugmaker Alvogen for its promotion of the alcoholism treatment disulfiram that omitted potentially life-threatening risks. Read More
The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More