Sun seeks to get the ball rolling again on Taro acquisition
MUMBAI, India An Indian generic company will restart its bid to buy an Israeli drug maker.
Sun Pharmaceutical Industries announced last week that it had filed an application with the Federal Trade Commission and the Antitrust Division of the Department of Justice to restart the Hart-Scott-Rodino Act waiting period related to its tender offer to buy Taro Pharmaceutical Industries through subsidiary Alkaloida Chemical Co.
The Supreme Court of Israel issued an order temporarily suspending the offer until it makes a decision on litigation by Taro against Alkaloida concerning the applicability of the offer under Israeli law.
Japanese drug maker permitted to start clinical trials of diabetes drug
OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.
Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.
The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.
FDA rejects application for new epilepsy drug
TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.
Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.
J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.