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The painkiller Celebrex nearly halves the chance of developing colon polyps but nearly doubles the risk of heart problems, say newly published studies that may rule out the drug's widespread use for preventing cancer.
Sanofi-aventis announced that the U.S. District Court for the Central District of California has set a revised trial date of December 4, 2006, for the separate trial on intent issues in the Lovenox patent infringement case against Amphastar and Teva pending before that court.
Curis, Inc., a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, announced that pursuant to the terms of its 2003 collaboration agreement with Genentech it has elected to cease its participation in the co-development of the basal cell carcinoma drug candidate for which the parties had previously announced they were halting enrollment in the Phase I clinical trial and had made a decision not to move forward with the molecule in its current formulation.
Attorneys for Merck & Co. want to see bank and cellphone records that could show the extent of a juror's financial relationship with a plaintiff who won a $32 million verdict against the drug company in the death of a 71-year-old man who took Vioxx.
Pfizer Inc said that a federal court in the Middle District of North Carolina has upheld the company's U.S. patent covering amlodipine besylate, the active ingredient in Norvasc, the world's most-prescribed branded medicine for treating hypertension.
The FDA and the industry must address inadequate brief-summary drug labeling to ensure that DTC ads protect public health, a prominent consultant says.
Biovail has asked a federal district court to block the FDA from approving any generic versions of its extended-release antidepressant, Wellbutrin XL, until after the agency resolves bioequivalence issues in a citizen petition filed by the drugmaker.
The FDA has been denied two of its central strategies in regulating compounded drugs by a federal court decision that could undermine future agency efforts to regulate this practice, industry sources said.