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.
Bristol-Myers Squibb completes part of Medarex acquisition
NEW YORK Bristol-Myers Squibb Co. has completed the initial part of its $2.4 billion tender offer for a Princeton, N.J.-based biotech company, the New York-based drug maker announced Thursday.
Bristol said 87.7% of shares of Medarex had been offered for sale and that it would attempt to acquire the remaining 12.3%. The offer for the remaining shares will expire at midnight Monday.
Medarex develops monoclonal antibodies using its UltiMAb platform.
Pfizer, Abbott to develop cancer treatment
NEW YORK Drug makers Pfizer and Abbott Labs have announced they will develop a test and therapy for non small-cell lung-cancer tumors.
Pfizer has developed an investigational drug, code named PF-02341066, which selectively targets cancer-causing genes that cause many cancers to progress, but to be eligible to receive it, patients must have a particular rearrangement of the genes found in such cancers as NSCLC.
Under the terms of the agreement, Abbott will develop a companion diagnostic test to determine whether patients in clinical trials can receive the drug.
“This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate, Pfizer Oncology Business Unit general manager Garry Nicholson said in a statement. “Working in close partnership with the experienced Abbott team, we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC.”