FDA changes HIV drug label
ROCKVILLE, Md. The Food and Drug Administration has notified healthcare professionals and patients of a change to the labeling of an HIV drug amid reports of adverse side effects.
The agency announced changes to the labeling of Tibotec Therapeutics drug Intelence (etravirine), citing reports of Stevens-Johnson syndrome, a severe skin disease that causes rashes and blisters, toxic epidermal necrolysis and erythema multiforme, an allergic reaction.
The FDA approved Intelence tablets in 2008. Tibotec is a division of Centocor Ortho Biotech Products, itself a division of Johnson & Johnson.
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.”