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
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...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
In Washington: With only hours to spare, House and Senate lawmakers were forced to pass a last-minute short-term extension of government funding (H.J. Res. 107) to stave off a government shutdown while congressional...more
On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of...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
According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time. The Yale University Open Data Access (“YODA”)...more