Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
By Jeannie Baumann
Jan. 22 — A pharmaceutical segment of Johnson & Johnson has suspended two clinical trials following news in France of a patient death during tests of another drug in the same class.
Janssen Research & Development LLC said the decision to stop a dosing study of an experimental treatment for mood disorders was entirely voluntary.
“At Janssen, the safety and well-being of patients who participate in our clinical trials are most important,” the company said in a Jan. 17 statement.
The announcement by Janssen came days after early phase testing of another anxiety drug in Rennes, France, was linked to the death of one research subject and the hospitalization of five others (10 LSLR 02, 1/22/16). French health ministers said they have opened a preliminary investigation into the study.
Janssen wasn't involved in the France-based study that led to the serious events as they are separate experimental drugs, but both drugs involved inhibiting the same enzyme, called fatty acid amide hydrolase.
The clinical trial in France was being conducted by the Rennes-based contract research laboratory Biotrial for the Portuguese laboratory Bial, which owns the molecule. Bial's experimental drug was also at an earlier, phase I stage of drug development compared to the phase II clinical trials being suspended by Janssen.
Janssen said the suspension was a precautionary measure, even though it hasn't received any reports of serious adverse events in patients with social anxiety disorder and major depressive disorder with anxious distress, either in the phase II trials or in earlier, phase I safety studies of the drug.
“We have informed health authorities, research sites, and study investigators about the change in status with these studies and instructed investigators to inform study patients as soon as possible,” the Janssen statement said.
To contact the reporter on this story: Jeannie Baumann in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Lee Barnes at email@example.com
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)