On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
In Washington: The Centers for Disease Control and Prevention (CDC) said it is looking to let cruise lines resume trips in the U.S. by mid-July and changing some of the rules to allow the ships to sail. A spokeswoman for...more
The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more
There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the...more